Drugs and Cosmetics Laws~ Powders-#Drugs and Cosmetics Laws~ Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams and hair oils, etc.#Drugs and Cosmetics Laws~ Nail Polishes and Nail Lacquers#Drugs and Cosmetics Laws~ Lipsticks and Lipgloss, etc.#Drugs and Cosmetics Laws~ Depilatories#Drugs and Cosmetics Laws~ Preparations used for Eyes#Drugs and Cosmetics Laws~ Aerosol#Drugs and Cosmetics Laws~ Alcoholic Fragrance Solutions#Drugs and Cosmetics Laws~ Hair Dyes#Drugs and Cosmetics Laws~ Tooth Powders and Tooth Pastes, etc.#Drugs and Cosmetics Laws~ Toilet Soaps#Drugs and Cosmetics Laws~ SCHEDULE M III#Drugs and Cosmetics Laws~ GENERAL REQUIREMENTS#Drugs and Cosmetics Laws~ Requirements of Manufacture of Medical Devices#Drugs and Cosmetics Laws~ Raw-Materials#Drugs and Cosmetics Laws~ SCHEDULE N#Drugs and Cosmetics Laws~ Entrance#Drugs and Cosmetics Laws~ Premises#Drugs and Cosmetics Laws~ Furniture and apparatus#Drugs and Cosmetics Laws~ General provisions#Drugs and Cosmetics Laws~ SCHEDULE O#Drugs and Cosmetics Laws~ Provisions applicable to other disinfectant fluids#Drugs and Cosmetics Laws~ SCHEDULE P#Drugs and Cosmetics Laws~ [SCHEDULE P I#Drugs and Cosmetics Laws~ SCHEDULE Q#Drugs and Cosmetics Laws~ SCHEDULE R#Drugs and Cosmetics Laws~ Condoms#Drugs and Cosmetics Laws~ Other Mechanical Contraceptive#Drugs and Cosmetics Laws~ SCHEDULE R1#Drugs and Cosmetics Laws~ SCHEDULE S#Drugs and Cosmetics Laws~ SCHEDULE T#Drugs and Cosmetics Laws~ Area Specifications/requirement for an applicant companies only to have GMP of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineral/metallic compounds) of Ayurveda, Siddha and Unani medicines

II. REQUIREMENTS OF PLANT AND EQUIPMENT

The following equipment, area and other requirements are recommended for the manufacture of-

A. Powders-Face powder, cake make-up, compacts, face packs, masks and rouges, etc.

Equipment:

(a) Powder mixer of suitable type provided with a dust collector.

(b) Perfume and colour blender.

(c) Sifter with sieves of suitable mesh size.

(d) Ball mill or suitable grinder.

(e) Trays and scoops (stainless steel).

(f) Filling and sealing equipment provided with dust extractor.

(g) For compacts-

(i) A separate mixer,

(ii) Compact pressing machine.

(h) Weighing and measuring devices.

(i) Storage tanks.

An area of 15 square metres is recommended. The section is to be provided with adequate exhaust fans.

B. Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams and hair oils, etc.

(a) Mixing and storage tanks of suitable materials.

(b) Heating kettle-steam, gas or electrically heated.

(c) Suitable agitator.

(d) Colloidal moll or homogeniser (wherever necessary).

(e) Triple roller mill (wherever necessary).

(f) Filling and sealing equipment.

(g) Weighing and measuring devices.

An area of 25 square metres is recommended.

C. Nail Polishes and Nail Lacquers

1. Equipment:

(a) A suitable mixer.

(b) Storage tanks.

(c) Filling machine-hand operated or power driven.

(d) Weighing and Measuring devices.

An area of 15 square metres is recommended. The section shall be provided with flame proof exhaust system.

2. Premises-The following are the special requirements related to Nail Polishes and Nail Lacquers:-

(a) It shall be situated in an industrial area.

(b) It shall be separate from other cosmetic manufacturing areas by metal/brick partition up to ceiling.

(c) Floors, walls, ceilings and doors shall be fire proof.

(d) Smoking, cooking and dwelling shall not be permitted and no naked flame shall be brought in the premises.

(e) All electrical wiring and connections shall be concealed and main electric switch shall be outside the manufacturing area.

(f) All equipment, furniture and light fittings in the section shall be flame proof.

(g) Fire extinguisher like foam and dry powder and sufficient number of buckets containing sand shall be provided.

(h) All doors of the section shall open outwards.

3. Storage-All explosive solvents and ingredients shall be stored in metal cupboards or in a separate enclosed area.

4. Manufacture:

(a) Manufacture of lacquer shall not be undertaken unless the above conditions are complied with.

(b) Workers shall be asked to wear shoes with rubber soles in the section.

5. Other requirements-No objection certificate from the local Fire Brigade Authorities shall be furnished.

D. Lipsticks and Lipgloss, etc.

Equipment:

(a) Vertical mixer.

(b) Jacketted Kettle-steam, gas or electrically heated.

(c) Mixing vessel (stainless steel).

(d) Triple roller mill/Ball mill.

(e) Moulds with refrigeration facility.

(f) Weighing and measuring devices.

An area of 15 square metres is recommended.

E. Depilatories

Equipment:

(a) Mixing tanks

(b) Mixer.

(c) Triple roller mill or homogeniser (where necessary).

(d) Filling and sealing equipment.

(e) Weighing and measuring devices.

(f) Moulds (where necessary).

An area of 10 square metres is recommended.

F. Preparations used for Eyes-Such preparations shall be manufactured under strict hygienic conditions to ensure that these are safe for use.

1. EYEBROWS, EYELASHES, EYELINER, ETC.

Equipments:

(a) Mixing tanks.

(b) A suitable mixer.

(c) Homogeniser (where necessary).

(d) Filing and sealing equipment.

(e) Weighing and measuring devices.

An area of 10 square metres is recommended.

2. KAJAL AND SURMA

Equipments:

(a) Base steriliser.

(b) Powder steriliser (dry heat oven).

(c) Stainless steel tanks.

(d) A suitable mixer.

(e) Stainless steel sieves.

(f) Filling and sealing arrangements.

(g) Weighing and measuring devices.

(h) Homogeniser (where necessary).

(i) Pestle and Mortar (for Surma).

An area of 10 square metres with a separate area of 5 square metres for base sterilization is recommended.

Other requirements for 1 and 2:

(a) False ceiling shall be provided wherever required.

(b) Manufacturing area shall be made fly proof. An airlock or an aircurtain shall be provided.

(c) Base used for Kajal shall be sterilised by heating the base at 150 degree C for required time in a separate enclosed area.

(d) The vegetable carbon black powder shall be sterilised in a drying oven at 120 degree C for required time.

(e) All utensils used for manufacture shall be of stainless steel and shall be washed with detergent water, antiseptic liquid and again with distilled water.

(f) Containers employed for 'Kajal' shall be cleaned properly with bactericidal solution and dried.

(g) Workers shall put on clean overalls and use handgloves wherever necessary.

G. Aerosol:

Equipment:

(a) Air compressor (wherever necessary).

(b) Mixing tanks.

(c) Suitable propellant filling and crimping equipments.

(d) Liquid filling unit.

(e) Leak testing equipment.

(f) Fire extinguisher (wherever necessary).

(g) Suitable filtration equipment.

(h) Weighing and measuring devices.

An area of 15 square metres is recommended.

2. Other requirements-No objection certificate from the Local Fire Brigade Authorities shall be furnished.

H. Alcoholic Fragrance Solutions

Equipment:

(a) Mixing tanks with stirrer.

(b) Filtering equipment.

(c) Filling and sealing equipment.

(d) Weighing and measuring devices.

An area of 15 square metres is recommended.

I. Hair Dyes

Equipment:

(a) Stainless steel tanks.

(b) Mixer.

(c) Filling unit.

(d) Weighing and measuring devices.

(e) Masks, gloves and goggles.

An area of 15 square metres with proper exhaust is recommended.

J. Tooth Powders and Tooth Pastes, etc.

1. Tooth Powder in General

Equipments:

(a) Weighing and measuring devices.

(b) Dry mixer (powder blender)

(c) Stainless steel sieves.

(d) Powder filling and sealing equipments.

An area of 15 square metres with proper exhaust is recommended.

2. Tooth Pastes

Equipments:

(a) Weighing and measuring devices.

(b) Kettle-steam, gas or electrically heated (where necessary).

(c) Planetory mixer with deaerator system.

(d) Stainless steel tanks.

(e) Tube filling equipment.

(f) Crimping machine.

An additional area of 15 square metres with proper exhaust is recommended.

3. Tooth Powder (Black)

Equipment:

(a) Weighing and measuring devices.

(b) Dry mixer powder blender.

(c) Stainless steel sieves.

(d) Powder filling and arrangements.

An area of 15 square metres with proper exhaust is recommended. Areas for manufacturing "Black" and "White" tooth powders should be separate.

K. Toilet Soaps

Equipment :

(a) Kettles/pans for saponification.

(b) Boiler or any other suitable heating arrangement.

(c) Suitable stirring arrangement.

(d) Storage tanks or trays.

(e) Driers.

(f) Amalgamator/chipping machine.

(g) Mixer.

(h) Triple roller mill.

(i) Granulator.

(j) Plodder.

(k) Cutter.

(l) Pressing, stamping and embossing machine.

(m) Weighing and measuring devices.

A minimum area of 100 square metres is recommended for the small scale manufacture of toilet soaps.

The areas recommended above are for basic manufacturing of different categories of cosmetics. In addition to that separate adequate space for storage of raw materials, finished products, packing materials, shall be provided in factory premises.

Note I.- The above requirements of Schedule are made subject to the modification at the discretion of the Licensing Authority, if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of particular case.

Note II.- The above requirements do not include requirements of machinery, equipments and premises required for preparation of containers and closures of different categories of cosmetics. The Licensing Authority shall have the discretion to examine the suitability and adequacy of the machinery equipments and premises for the purpose taking into consideration of the requirements of the licensee.

Note III.-Schedule M II specifies equipments and space required for certain categories of cosmetics only. There are other cosmetics items, viz., Attars, perfumes, etc., which are not covered in the above categories. The Licensing Authority shall, in respect of such items or categories of cosmetics, have the discretion to examine the adequacy of factory premises, space, plant and machinery and other requisites having regard to the nature and extent of the manufacturing operations involved and direct the licensee to carry on necessary modification in them.]

1[SCHEDULE M III

(See rule 76)

REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES

1. GENERAL REQUIREMENTS

1.1.1 Location and Surroundings-The factory building(s) shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall not be used for residence or inter-connected with residence. It shall be well ventilated and clean.

1.1.2 Buildings-The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects, rodents, flies, etc.

_______________________

 1. Ins. by G.S.R. 109(E), dated 22nd February, 1994 (w.e.f. 22-2-1994).

The walls of the rooms in which manufacturing operations are carried out, shall be up to a height of six feet from the floor, be smooth, water-proof and capable of being kept clean. The floor shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust.

1.1.3 Water Supply-The water used in manufacture shall be of potable quality.

1.1.4 Disposal of waste-Suitable arrangements shall be made for disposal of waste water.

1.1.5 Health, Clothing and Sanitation of workers-All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks, headgears and gloves wherever required. Washing facilities shall also be provided.

1.1.6 Medical Services-Adequate facilities for first-aid shall be provided.

1.1.7 Work benches shall be provided for carrying out operations such as moulding, assembling, labelling, packing etc. Such benches shall be fitted with smooth impervious tops capable of being washed.

1.1.8 Adequate facilities shall be provided wherever required for cleaning, washing drying of different containers of devices.

1.1.9 The premises shall be kept under controlled conditions of temperature and humidity so as to prevent any deterioration in the properties of materials and products due to storage and process conditions.

2. Requirements of Manufacture of Medical Devices-

The process of manufacture of medical devices shall be conducted at the licensed premises, wherever required, and shall be divided into the following separate operations/sections-

(1) Moulding (wherever manufacture of medical devices is to start from granules).

(2) Assembling (including cutting, washing and drying, sealing, packing, labelling, etc.).

(3) Raw Materials.

(4) Storage Area.

(5) Washing, drying and sealing area (wherever required).

(6) Sterilization.

(7) Testing facilities.

The following equipments and space are recommended for the basic manufacture of different categories of medical devices.-

A. Sterile Disposable Perfusion and Blood Collection Sets.

(1) Moulding:

(a) Injection Moulding Machine

(b) Extruder Machine

(c) PVC Resin Compounding Machine

(2) Assembling :

(a) Hand Pressing Machine for filter fixing a Drip Chamber.

(b) Bag Sealing Machine.

(c) Compressor Machine.

(d) Leak Testing Bench.

(e) PVC Tube Cutting Machine.

(f) Tube Winding Machine (wherever necessary).

(g) Welding Machine (wherever necessary).

An area of 30 square metres for Moulding and 15 square metres for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The moulding section shall, if necessary, have proper exhaust system.

Note.-An additional area of 20 square metres is recommended for any extra category.

B. Sterile Disposable Hypodermic Syringes.

(i) Moulding:

(a) Granulator

(b) Injection Moulding Machine

(c) Air-Compressor

(d) Weighing devices.

(ii) Assembling :

(a) Blister Pack Machine

(b) Vacuum Dust Cleaner

(c) Rubber-tip Washing-Machine

(d) Foil Stamping or screen printing equipment.

An area of 30 square metres for moulding and 15 square metres for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The moulding section shall, if necessary, have proper exhaust system.

Note.-An additional area of 20 square metres is recommended for any extra category.

C. Sterile Disposable Hypodermic Needles.

(i) Moulding :

(a) Needle grinding and levelling machine

(b) Electropolishing Machine

(c) Cutting Machine

(d) Injection Moulding Machine

(e) Needle Pointing Deburrine Machine

(f) Air-Compressor.

(ii) Assembling :

(a) Needle cleaning Machine with Magnetic Separator

(b) Blister Packing Machine

(c) Needle Inspection Unit.

An area of 30 square metres for Moulding and 15 square metres for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The moulding section shall, if necessary, have proper exhaust system.

Note.-An additional area of 20 square metres is recommended for any extra category.

3. Raw-Materials

The licensee shall keep an inventory of all raw materials to be used at any stage of manufacture of devices and shall maintain records as per Schedule U. All such raw materials shall be identified and assigned control reference number. They shall be conspicuously labelled indicating the name of the material, control reference number, name of the manufacturer and be specifically labelled "Under Test" or "Approved" or "Rejected". The under test, approved or rejected materials shall appropriately be segregated. These shall be tested for compliance with required standards of quality.

A minimum area of 10 square metres shall be provided for storage of raw materials.

4. Storage Area-The licensee shall provide separate storage facilities for quarantine and sterilized products.

An area not less than 10 square metres shall be provided for each of them.

5. Washing, drying and sealing area-The licensee shall provide wherever required adequate equipments like water distillation still, deionizer, washing machine, drying over with trays for washing, drying and sealing of medical device.

An area not less than 10 square metres shall be provided.

6. Sterilization-The licensee shall provide requisite equipments with required controls and recording device for sterilization of medical devices by Ethylene Oxide Gas in his own premises or may make arrangements with some Institution approved by the Licensing Authority for sterilization. The products sterilized in this manner shall be monitored to assure acceptable levels of residual gas and its degradation products. An area of 10 square metres is recommended for basic installation of such facility:

Provided that the above equipment may not be required in case the licensee opts for sterilization of medical devices by Ionising Radiation.

7. Testing facilities-The licensee shall provide testing laboratory for carrying out Chemical and Physio-Chemical testing of medical devices and of raw materials used in its own premises:

Provided that the Licensing Authority shall permit the licensee in the initial stage to carry out testing of sterility, pyrogens, toxicity 1[wherever applicable] on their products from the approved testing institutions but after one renewal period the licensee shall provide testing facilities of all such tests in their own premises.

8. Records-The licensee shall maintain records of different manufacturing activities with regard to each stage of manufacture in-process controls, assembling, packing, batch records for the quantity of devices manufactured from each lot of blended granules, duration of work, hourly quantum of production in respect of each item as well as record of each sterilizing cycle of the gaseous method employed.

Note.- The above requirements of machinery, equipments, space, qualifications are made subject to the modification at the discretion of the Licensing Authority, if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of a particular case.]

2[SCHEDULE N

[See rule 64(1)]

LIST OF MINIMUM EQUIPMENT FOR THE EFFICIENT RUNNING OF A PHARMACY

1. Entrance-

The front of a pharmacy shall bear an inscription "Pharmacy" in front.

2. Premises-

The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well-built, dry, well-lit and ventilated and of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept

________________________

1. Ins. by G.S.R. 548(E), dated 16th July, 2003 (w.e.f. 16-7-2003).

2. Subs. by S.O. 2139, dated 5th June, 1972 (w.e.f. 12-8-1972).

 in a clearly visible and appropriate manner. The area of the section to be used as dispensing department shall be not less than 6 square metres for one pharmacist working therein with additional 2 square metres for each additional pharmacist. The height of the premises shall be at least 2.5 metres.

The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.

A pharmacy shall be provided with ample supply of good quality water.

The dispensing department shall be separated by a barrier to prevent the admission of the public.

3. Furniture and apparatus-

The furniture and apparatus of a pharmacy shall be adapted to the uses for which they are intended and correspond to the size and requirements to the establishment.

Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust.

Every container shall bear a label of appropriate size, easily readable with names of medicaments as given in the Pharmacopoeias.

A pharmacy shall be provided with dispensing bench, the top of which shall be covered with washable and impervious material like stainless steel, laminated or plastic, etc.

A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the word "POISON" in red letters on a white background.

Containers of all concentrated solution shall bear special label or marked with the word "TO BE DILUTED".

A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions:-

Apparatus:-

Balance, dispensing, sensitivity 30 mg.,

Balance, counter, capacity 3 Kgm., sensitivity 1 gm.

Beakers, lipped, assorted sizes.

Bottles, prescription, ungraduated assorted sizes.

Corks assorted sizes and tapers.

Cork, extracter.

Evaporating dishes, porcelain.

Filter paper.

Funnels, glass.

Litmus paper, blue and red.

Measure glasses cylindrical 10 m., 25 ml., 100 ml. and 500 m.

Mortars and pesties, glass.

Mortars and pesties, wedgwood.

Ointment pots with bakelite or suitable caps.

Ointment slab, porcelain.

Pipettes, graduated, 2 ml., 5 ml. and 10 ml.

Ring, stand (retort) iron, complete with rings.

Rubber stamps and pad.

Scissors.

Spatulas, rubber or vulcanite.

Spatulas, stainless steel.

Spirit lamp.

Glass stirring rods.

Thermometer, 0° to 200°C.

Tripod stand.

Watch glasses.

Water bath.

Water distillation still in case Eye drops and Eye lotions are prepared

Weights, Metric, 1 mg. to 100 gm.

Wire Gauze.

*Pill finisher, boxwood.

*Pill Machine

*Pill Boxes.

*Suppository mould.

Books:

The Indian Pharmacopoeia [Current Edition]

National Formulary of India [Current Edition]

The Drugs and Cosmetics Act, 1940.

The Drugs and Cosmetics Rules, 1945.

The Pharmacy Act, 1948.

The Dangerous Drugs Act, 1930.

4. General provisions-

A pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist whose name shall be displayed conspicuously in the premises.

The Pharmacist shall always put on clean white overalls.

The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean.

All records and registers shall be maintained in accordance with the laws in force.

Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person.

Medicaments when supplied shall have labels conforming to the provisions of laws in force.

Note.- The above requirements are subject to modifications at the discretion of the Licensing Authority if he is of opinion that having regard to the nature of drugs dispensed, compounded or prepared by the licensee. It is necessary to relax the above requirements or to impose additional requirements in the circumstances of a particular case. The decision of the Licensing Authority in that regard shall be final.

* These items are to be provided only by those who intend to dispense pills or suppositories, as the case may be.]

1[SCHEDULE O

[See rule 126]

STANDARD FOR DISINFECTANT FLUIDS

2[PART I

Provisions Applicable to black fluids and white fluids

The standards for disinfectants shall conform to the Indian Standards specification (IS 1061: 1997) laid down from time to time by the Bureau of Indian Standards.]

____________________

1. Added by Notification No. F. 1-20/60-D, dated 24th January, 1964, and subs. by G.S.R. 1243, dated 19th September, 1979, (w.e.f. 6-10-1979).

2. Subs. by G.S.R. 735(E), dated 21st December, 2005, for

“PART I

Provision applicable to Black Fluids and White Fluids

1. CLASSIFICATION—The disinfectants shall be classified as follows:—

(a) Black fluids.

(b) White fluids.

(A) Black fluids—These shall be homogeneous dark brown solution of coal tar acids or similar acids derived from petroleum with or without hydrocarbons, and/or other phenolic compounds, and their derivatives and a suitable emulsifier.

(B) White fluids—These shall be finely dispersed homogeneous white to off-white emulsion consisting of coal tar acids or similar acids derived from petroleum, with or without hydrocarbons, and/or other phenolic compounds, and their derivatives. 

2. GRADATION—Each of the above classes of disinfectant fluids shall be graded on the basis of the minimum requirements in respect of:  

Rideal Walker (RW) Coefficient as follows:—

Grade   

 Rideal Walker (R.W.)   

 Coefficient (Minimum)

1.   

 18   

 

2.   

 10   

 

3.   

 5   

 

3. TYPE—Each of the above grades of disinfectant fluids shall be stable in the range of temperature indicated against each type—

Type   

 Stable in the range of

(I) Normal   

 15oC to 45oC

(II) Winder   

 5oC to 30oC

4. REQUIREMENTS—All classes and grades of disinfectant fluids shall comply with the following requirements, namely:—

(1) Stability after dilution—When tested by the method described hereinafter the disinfectant fluids shall be miscible with artificial hard water (for Black fluids) or with artificial sea water (for White fluids) in all proportion from 1 per cent to 5 per cent by volume, to give emulsion which shall not break or show more than traces of separation of either top or bottom oil when kept for 6 hours at 15oC to 45oC for Type (I) (Normal) and 5oC to 30oC for Type (II) (Winter).

(2) Germicidal Value—Rideal Walker Coefficient—Black fluids and White fluids shall be tested for the determination of Rideal Walker Coefficient (R.W. Coefficient) by the method described hereinafter. (3) Storage—Disinfectant fluids of all classes shall be stored in mild steel, tinned mild steel or other suitable containers. These shall not be stored in containers made of galvanised iron. (4) Labelling—Subject to the other provisions in these rules, the label on the container shall state—

(i) the name of the product,

(ii) the name and full address of the manufacturer,

(iii) grade, type, R.W. Coefficient of product,

(iv) date of manufacture,

(v) quantity present in the container,

(vi) indications and mode of use, and

(vii) date up to which the product can be used.

5. METHOD OF TESTING—

(1) Preparation of sample—The sample of disinfectant fluids to be tested should be mixed thoroughly taking care that no air is beaten into the fluid immediately before withdrawing ny portion for testing. The rest portion should be withdrawn from the middle of the sample.

(2) Method of testing stability after dilution—

(a) Preparation of Artificial Hard Water : 40 ml. of IN Hydrochloric Acid (Analytical Reagent Quality) is neutralised with a slight excess of Calcium Carbonate and filtered. The filtrate is diluted to 1000 ml. with distilled water, 10 parts of this solution is further diluted to 100 parts with distilled water.

(b) Preparation of Artificial Sea Water : 27 G of Sodium Chloride (Analytical Reagent Quality) and 5 g of Magnesium Sulphate (Analytical Reagent Quality) are dissolved in distilled water and diluted to 1000 ml. The solution is filtered before use.

(c) Procedure : Take 1 ml. and 5 ml. portions of the sample in duplicate in 100 m. stoppered measuring cylinder (IS : 878-1956) by means of pipettes. Dilute the sample with Artificial Hard water of Artificial Sea water (as the case may be) upto 10 ml. mark. Mix thoroughly by inverting the cylinders 5 times. Keep the cylinders containing the diluted fluids for 6 hours at the extremes of the temperature range specified for the articular type.

The sample complies with the test if the solution shows not more than a trace of separation at its top and bottom.

(3) Method of determination of Rideal Walker Coefficient (R.W.C.)

Apparatus—A loop, 4 mm. in internal diameter is made at end of a 28 swg (0.376 mm) wire of platinum or platinum iridium alloy, 38 mm. long from the loop to the holder. The loop is bent at such an angle to the length of the wire as will facilitate in removal vertically from the surface of the liquid while keeping the place of the loop horizontal.

Incubator—Set and maintained at 37oC + 1oC.

Pipettes—Standard graduated pipettes of capacity 10 ml.; 5 ml, and 1 ml.

Dropping Pipette—Made to deliver 0.2 ml.

Medication tubes—5 sterile plugged rimless test tubes 125 mm x 22 mm (5 inch x 3/4 inch) made of hard neutral glass.

Broth tubes—About 2 dozens of the same description as medication tubes.

Standard measuring cylinders stopped and graduated—500 ml. graduated in 10 ml.—100 ml. graduated 1 ml.—five. All apparatus must be scrupulously clean and sterile immediately before use.

Reagents— (a) Broth—Prepare a mixture of the following ingredients:

Meat extract (Microbiological grade) 20 g. Peptone (Micro biological grade) 20 g. Sodium Chloride (Reagent Quality) 10 g. Distilled Water—1000 ml. Dissolve the solid in distilled water add sufficient sodium hydroxide to neutralise the solution; then boil it to bring down phosphates and filter while hot. The broth thus prepared is then adjusted to pH. 7.6 with normal Hydrochloric acid. The broth is then sterilised by autoclaving at 15 lbs. pressure for 20 minutes. It is then filtered and placed in 5 ml. quantities in sterilised broth tubes. The tubes of media thus prepared are sterilised by autoclaving at 15 Ibs. pressure for 10 minutes. The final pH of the medium should lie between 7.3 and 7.5. Further resterilisation in bulk or in tubes is not permissible.

(b) Test Organism—The organism used in Salmonella typhi (NCTC 786) of which suitable culture shall be obtained from the Director, Central Drugs Laboratory, Calcutta. This culture is maintained by weekly sub-culture on a nutrient agar slope [made by dissolving 2.5 per cent Agar (Bacteriological grade) in the broth prepared as above, incubating the sub-culture for 24 hours at 370C and then storing in refrigerator at a temperature below 220C. For the purpose of the test a little of the growth from the most recent sub-culture in nutrient agar slope is placed in tube of R.W. broth and incubated for 23 hours at 380C. A standard loopful  is then transferred to a second tube and incubated as before. This is done for at least three times before a test is carried out. Sub-culturing in broth is limited to 14 days.

(c) Standard phenol : 5 per cent W/V solution in sterile distilled water of chemically pure phenol having a crystallising point of not less than 40.50C is prepared. Test dilutions are prepared from this stock solution containing 1 g. of phenol in each 95, 100, 105, 115 ml. of the solution made. These dilutions shall be used within a week of preparation.

(d) Test dilutions of Disinfectant (sample)—The sample is prepared as described under “Preparation of samples”. A test portion of 5 ml. is withdrawn as discharged into about 480 ml. of sterile distilled water in a 500 ml. glass stoppered sterile measuring cylinder and the pipette is rinsed three times or more in the clear liquid. The whole is then made up to 500 ml. with sterile distilled water, the cyclinder is stoppered and the contents thoroughly mixed by inverting the cylinder several times. Suitable test dilutions in sterile distilled water are then immediately prepared from this stock solution.

Procedure—5 ml. of 4 chosen dilutions of the disinfectant are placed in 4 medication tubes which are then placed in a rack provided with water bath maintained at a constant temperature between 170C and 190C, with strongest dilution on the left. The fifth medication tube containing 5 ml. of the particular phenol dilution is  placed on the right. When the content on the medication tubes and broth culture of the test organism have reached the temperature of the water bath, starting at Zero time, 0.2 ml. of the culture is added to the left hand medication tube and the tube is shaken gently. After 30 seconds the next tube is inoculated similarly and the process is repeated with each successive tube at intervals of 30 seconds until the phenol control has been inoculated. Thirty second after this last addition (that is 2-1/2 minutes from zero) a loopful of the well-shaken content of the tube at the extreme left is withdrawn and placed in tube containing 5 ml. of the broth medium. Thirty second after this similar operation is performed on the second medication tube. The procedure is repeated at an interval of 30 seconds with each of the 5 medication tubes working from left to right until 4 sets of cultures have been made i.e. at 2-1/2, 5, 7-1/2 and 10 minutes respectively after exposure. In each withdrawal care should be taken to ensure  that the loop is removed vertically from the surface of the liquid with its place horizontally and without touching the side of test tubes. The loop shall be sterilised by flaming between each operation, care being taken that the loop is cooled before being again used. The inoculated broth tubes are incubated for not less than 48 hours and not more than 72 hours at 370C when the tubes showing growth of the test organisms will be recognised by turbidity of the broth.

Calculation of coefficient—The R.W. coefficient is obtained by dividing that dilution of the disinfectant which shows life of test organism in 2-1/2 and 5 minutes but no life thereafter by that dilution of the phenol which gives the same response.

PART II

Provisions applicable to other disinfectant fluids:

Disinfectant fluids which are made with chemicals other than those specified under Part I of this Schedule shall conform to the formula or list of ingredients shown on the label. 

Labelling : Subject to the provisions of rules on labelling, the label of container shall state-

(i) the name of the product;

(ii) the names and full address of the manufacturer;

(iii) the full formula or list of ingredients of the preparation;

(iv) date of manufacture;

(v) date up to which the product can be used;

(vi) quantity present in the container, and

(vii) indications and mode of use.

Cautionary note:

Mercury compounds shall be strictly excluded from all grades.]

1[SCHEDULE P

(See rule 96)

LIFE PERIOD OF DRUGS

Sl.No.   

 Name of the drug   

 Period in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified in Column No. 4

Conditions of storage

(1)

 (2)

(3)

 (4)

 ANTIBIOTICS   

   

1. Adramycin   

 30   

 In a cool place

2. Ampicillin   

 36   

 In a cool place

3. Ampicillin Capsules   

 24   

0

____________________

Contd. from pervious page

Sample disinfectant Dilutions

Time of exposures in minutes

5

10

 

1: 1000

-

-

-

-

 

1: 1100

+

-

-

-

R. W. Coefficient

1: 1200

+

+

-

-

=1200/100=12

1: 1300

+

+

+

-

 

1: 100 Phenol Control

+

+

-

-

 

(+ = growth; — = No growth) ” (w.e.f. 21-12-2005).

1. Added by Notification No. 1-7/62-D, dated 11th May, 1964 and subs. by G.S.R. 17(E), dated 7th January, 1986, (w.e.f. 7-1-1986), corrected vide corrigendum G.S.R. 1059(E), dated 5th September, 1986.

4.

Ampicillin Dry Syrup

24

 

5.

Ampicillin Injection

24

 

6.

Ampicillin Sodium

36

In a cool place.

7.

Ampicillin Trihydrate

30

In a cool place.

8.

Amoxycillin Trihydrate

36

In a cool place.

9.

Amoxycillin Trihydrate capsules

24

 

10.

Amoxycillin Trihydrate Dry Syrup

18

 

11.

Bacitracin

18

In a cool place.

12.

Bacitracin or Zinc Bacitracin Tablets

12

 

13.

Bacitracin Lozenges

12

 

14.

Carbenicillin Sodium Injection

24

At temperature not exceeding 50C.

15.

Carbanicillin Sodium Powder

24

At temperature not exceeding 50C.

16.

Cephalexin

24

In a cool place.

17.

Chloramphenicol

60

In a cool place.

18.

Chloramphenicol Capsules & Tablets

48

 

19.

Chloramphenicol Palmitate

48

 

20.

Chloramphenicol Palmitate Oral suspension

36

 

21.

Chloramphenicol Eye Drops

24

 

22.

Chloramphenicol Sodium Succinate Powder

48

In a cool place.

23.

Chloramphenicol Sodium Succinate Injection

36

In a cool place.

24.

Chlortetracycline Hydrochloride

60

In a cool place.

25.

Chlortetracycline Hydrochloride Capsules

60

 

26.

Chlortetracycline Hydrochloride Tablets

24

 

27.

Chlortetracycline Hydrochloride Ointment

24

 

28.

Cloxacillin (Oral)

36

In a cool place.

29.

Cloxacillin Sodium (Injection Grade)

36

In a cool place.

30.

Colistin Sulphate

60

Protected from light.

31.

D-Cycloserine

48

In a cool place.

32.

Dimethyl Chlortetracycline Hydrochloride

48

 

33.

Dimethyl Chlortetracycline Hydrochloride Capsules

36

 

34.

Daunoblastin Injection

36

 

35.

Doxycycline Hydrochloride

48

In a cool place.

36.

Doxycycline Monohydrate

36

In a cool place.

37.

Doxycycline Monohydrate for Oral Suspension

24

 

38.

Doxycycline Monohydrate Capsules

36

 

39.

Erythromycin Estolate

36

In a cool place.

40.

Erythromycin Ethylsuccinate

60

In a cool place.

41.

Erythromycin Oral Suspension

36

 

42.

Erythromycin Estolate for Oral Suspension

36

 

43.

Erythromycin Ethyl Succinate Tablet

24

 

44.

Erythromycin Estolate Tablets

24

 

45.

Erythromycin Stearate

36

In a cool place.

46.

Framycetin Sulphate

48

In a well closed container with temperature not exceeding 300C.

47.

Framycetin Sulphate Eye Drops

24

In a well closed container with temperature not exceeding 300C.

48.

Framycetin Sulphate Ointment

24

In a well closed container with temperature not exceeding 300C.

49.

Gentamycin Sulphate

60

In a cool place.

50.

Gentamycin Sulphate Injection

36

 

51.

Gramicidin

60

In a cool place.

52.

Griseofulvin

48

In a cool place.

53.

Griseofulvin Tablets

36

 

54.

Kanamycin Sulphate Injection

24

 

55.

Kanamycin Acid Sulphate Powder

48

In a cool place.

56.

Mitomycin C

48

In a cool place.

57.

Neomycin Sulphate

48

In a cool place.

58.

Nystatin

36

At a temperature not exceeding 50C.

59.

Oleandomycin Phosphate Sterile

24

In a cool place.

60.

Oleandomycin Phosphate Non-Sterile

36

In a cool place.

61.

Oxytetracycline Hydrochloride

48

In a cool place.

62.

Oxytetracycline Hydrochloride Capsules

36

 

63.

Oxytetracycline Hydrochloride Tablets

24

 

64.

Oxytetracycline Hydrochloride Injection

24

 

65.

Oxytetracycline Hydrochloride Ointment

36

 

66.

Penicillin Crystalline

36

In a cool place.

67.

Penicillin Tablets

18

In a cool place.

68.

Procaine Penicillin G

36

In a cool place.

69.

Benzathin Penicillin G

48

In a cool place.

70.

Potassium Phenoxy Methyl Penicillin

48

In a cool place.

71.

Potassium Phenoxy Methyl Penicillin Tablets

24

 

72.

Polymixin B Sulphate

48

In a cool place

73.

Polymixin B Sulphate Ointment or Powder

24

In a cool place.

74.

Rifampicin

36

In a cool place.

1[75. Rifampicin Capsules

36]

 

76.

Spiramycin Base

24

In a cool place.

77.

Streptomycin Injection

36

In a cool place.

78.

Streptomycin Ointment

24

 

79.

Streptomycin Tablets

24

 

80.

Streptomycin Sulphate

48

At temperature not exceeding 200C.

81.

Tetracycline Base

24

In a cool place.

82.

Tetracycline Hydrochloride

36

In a cool place

83.

Tetracycline Hydrochloride Capsules

36

 

84.

Tetracycline Tablets

24

 

85.

Tyrothricin

60

In a cool place.

VITAMINS

1.

Vitamin A Injection

24

 

2.

Vitamin B 1 Injection

24

 

3.

Thiamine Mononitrate Tablets

36

 

4.

Thiamine Hydrochloride

48

In a well closed container, protected from light, in a cool place.

5.

Thiamine Mononitrate

48

In a well closed container, protected from light, in a cool place.

6.

Riboflavin

60

In a well closed container, protected from light, in a cool place.

7.

Riboflavin 5 Phosphate

24

In a well closed container, protected from light, in a cool place.

8.

Riboflavin Tablets

36

 

9.

Vitamin B2 Injection

24

 

10.

Vitamin B6

60

In a well closed container, protected from light, in a cool place.

11.

Vitamin B 6 Tablets

36

 

12.

Cyanacobalamin

48

In a well closed container, protected from light, in a cool place.

13.

Hydroxycobalamin

48

In a well closed container, protected from light, in a cool place.

 _____________________________

1. Subs. by G.S.R. 250(E), dated 4th April, 2002 (w.e.f. 4-4-2002).

14.

Vitamin B12 Injection

36

 

15.

Calcium Pantothenate

36

In a well closed container, protected from light, in a cool place.

16.

Vitamin C Injection

24

 

17.

Calcium Pantothenate Tablets

36

 

1[18.

Vitamin C

48

In a well closed container, protected from light, in a cool place.]

19.

Vitamin D2 D3

36

In a well closed container, protected from light, in a cool place.

20.

Vitamin E or E-Acetate

60

In a well closed container, protected from light, in a cool place.

21.

Folic Acid

60

In a well closed container, protected from light, in a cool place.

22.

Folic Acid Tablets

36

 

23.

Vitamin K

60

In a well closed container, protected from light, in a cool place

24.

Vitamin K Injection

36

 

25.

Niacinamide

60

In a well closed container, protected from light, in a cool place.

26.

Niacinamide Tablets

36

 

27.

D-Panthenol

60

In a well closed container, protected from light, in a cool place.

INSULIN PREPARATIONS

 

 

1.

Golluline Zinc Insulin Injection

24

At temperature between 2oC and 8oC, must not be allowed to freeze.

2.

Insulin Injection

24

At temperature between 2oC and 8oC, must not be allowed to freeze.

3.

Insulin Zinc Suspension

24

At temperature between 2oC and 8oC, must not be allowed to freeze.

4.

Insphane Insulin Injection

24

At temperature between 2oC and 8oC, must not be allowed to freeze.

2[5.

Human Insulin Injection

30

At temperature between 2oC and 8oC, must not be allowed to freeze.]

NORMAL HUMAN PLASMA

 

 

1.

Anti-Haemophillic Human Globulin

12

In a cool place.

2.

Dried Plasma

60

At temperature not exceeding 25oC.

3.

Dried Normal Human Serum

 

 

 

Albumin

60

At temperature not exceeding 25oC.

4.

Frozen Plasma

60

In deep freeze.

5.

Liquid Plasma

24

In cold place.

__________________________

1. Subs. by G.S.R. 626(E), dated 14th October, 1991 (w.e.f. 14-10-1991).

2. Ins. by G.S.R. 215(E), dated 19th March, 1999 (w.e.f. 19-3-1999).

6.

Liquid Normal Human Serum Albumin

60

In cold place.

1[7.

Whole Human Blood--

 

 

(a) Collected in ACD Solution

21 days

At temperature between 4oC and 6oC.

(b) Collected in CPDA Solution

35 days

At temperature between 4oC and 6oC.]

SERA TOXIN & TOXOID

 

 

1.

Alum Precipitated Diphtheria Toxoid

24

In cold place.

2.

Alum Precipitated Diphtheria and Tetanus Toxoid and Pertussis Vaccine combined

18

In cold place.

3.

Alum Precipitated Tetanus Toxoid

24

In cold place.

4.

Aluminium Hydroxide Absorbed Diphtheria Toxoid

24

In cold place.

5.

Aluminium Hydroxide Absorbed Diphtheria Tetanus Toxoid and Pertussis Vaccine combined

18

In cold place.

6.

Aluminium Phosphate Absorbed Diphtheria Toxoid

24

In cold place.

7.

Aluminium Phosphate Absorbed Diphtheria and Tetanus Toxoid

24

In cold place.

8.

Aluminium Phosphate Absorbed Diphtheria Toxoid Tetanus Toxoid and Pertussis Vaccine combined

18

In a cool place.

9.

Diagnostic Diphtheria Toxin (Schick Test)

12

In cold place.

10.

Cobra Venom in Solution

3

Between 2oC and 5oC protected from light.

11.

Diphtheria Toxoid

24

In cold place.

12.

Inactivated Diagnostic Diphtheria Toxin

12

In cold place.

13.

Liquid Serum

12

Between 2oC and 10oC preferable at the lower limit.

14.

Lyophilised Anti-Snake Venom Serum

60

 

15.

Lyophilised Schick Test Toxin and control

60

 

16.

Old Tuberculin

60

In cold place.

17.

Thrombin (Bovine Original)

36

In cold place.

2[18.

Tetanus Toxoid

36

In cold place.]

19.

Tuberculin PPD

60

In cold place.

OTHER VACCINES

 

 

1.

Alum Precipitated Pertussis Vaccine

18

In cold place.

3[2.

BCG Vaccine

24

In cold place.]

3.

Cholera Vaccine

18

In cold place.

4.

DHL Vaccine (For Dog)

12

In cold place.

________________________

1. Subs. by G.S.R. 626(E), dated 14th October, 1991 (w.e.f. 14-10-1991).

2. Subs. by G.S.R. 26(E), dated 19th January, 2006 (w.e.f. 19-1-2006).

3. Susb. by G.S.R. 174(E), dated 16th March, 2005, for serial No. “2. BCG Vaccine 14 in cold place” (w.e.f. 16-3-2005).

5.

Measles Vaccine

24

In cold place.

6.

Plague Vaccine

36

In cold place.

7.

Polio Vaccine

24

When stored at minus 20oC.

6

When stored at ZerooC.

3

When stored at 4oC.

8.

Rabies Vaccine

6

In cold place.

9.

Typhoid Vaccine

18

In cold place.

10.

Typhoid and Para Typhoid Vaccine

18

In cold place.

11.

Typhoid Para Typhoid A and B Vaccine

18

In cold place.

12.

Typhoid Para Typhoid A, B and C Vaccine

18

In cold place.

13.

Typhoid Para Typhoid A, B and C and Tetanus Vaccine

18

In cold place.

14.

Typhus Vaccine

12

In cold place.

15.

Yellow Fever Vaccine

12

In cold place.

1[16.

Anti-Rabies Vaccine (Cell Culture)

24

In cold place.]

ANTI TOXIN

 

 

 

(For Serum Extracted preparations)

 

 

 

20% Excess potency

12

In cold place.

 

30% Excess potency

24

In cold place.

 

40% Excess potency

36

In cold place.

 

50% Excess potency

48

In cold place.

 

(for enzyme preparations) 5% Excess potency

12

In cold place.

 

10% Excess potency

24

In cold place.

 

15% Excess potency

36

In cold place.

 

20% Excess potency

48

In cold place.

MISCELLANEOUS DRUGS

2[1.

Adrenaline for Injection

12

[As prescribed in Indian Pharmacopoeia]

2.

Chorionic Gonadotrophin for Injection (Lyopholised)

36

At temperature not exceeding 20oC

3.

Corticotrophin

24

In cold place.

4.

Corticotrophin Lyophilised

36

In cold place.

5.

Heparin Injection

36

In a cold place.

6.

Liquid Extract of Ergot

12

In cold place.

7.

Liver Extract Crude Injection

24

In a cold place.

8.

Oxytocin Injection

24

In cold place.

9.

Paraldehyde Injection

6

In cool place protected from light.

10.

Pituitary Injection

24

In cold place.

11.

Vasopressin Injection

24

In cold place.

_________________________

1. Ins. by G.S.R. 215(E), dated 19th March, 1999 (w.e.f. 19-3-1999).

2. Subs. by G.S.R. 174(E), dated 16th March, 2005, for serial No. “1. Adrenaline for Injection 12 In cold place” (w.e.f. 16-3-2005).

Note. --     (1) The term “cool place” means place having a temperature between 10oC and 25oC.

(2) The term “cool place” means a place having a temperature not exceeding 8oC.

(3) Capsules should be kept in a well-closed container at temperature not exceeding 30oC.

(4) Wherever condition of storage is not specified in Column 4, it may be stored under normal room temperature.]

1[SCHEDULE P I

(See rule 109)

PACK SIZES OF DRUGS

Name of the Drug

Dosage form

Pack Size

1

2

3

Albendazole

Suspension

10 ml.

Atenolol

Tablets

14

Anti-Haemmorhoidal Topicals

Rectal Capsules

20

Aspirin (Low Dose)

Tablets

14

Cholecalciferol or Ergocalciferol

Granules

1 gm. Sachet

Ciclopiroxolamine

Vaginal Cream

30 gms.

Catalin

Ophthalmic drops

15 ml.

Famotidine

Tablets

14

Glyceryl Trinitrate

Spansules (Long Acting)

25

Isosorbide Dinitrate

Spansules (Long Action)

25

Isoniazide

Syrup

200 ml.

Ipecacuanha

Syrup

10 ml.

Oral Rehydration Salt (ORS)

Powder

Pouches to be reconstituted to one litre in one pack or in 5 unit dose sachets in one pack.

Piperazine

Granules

Syrup

5 gm.

30 ml.

Pyrantel Pamoate

syrup

8 ml. or 10 ml.

Potassium Chloride

Syrup

60 ml. and 200 ml.

Progestogen Qestrogen (Combinations for Oral Contraception)

Tablets

21 or 22 with or

without 7 placebo

Roxatidine Acetate

 

 

Hydrochloride

Tablets

14

Vitamine A Oral Drops

Drops

7.5 ml.]

2[Co-trimoxazole

Suspension

50 ml.

Haloperidol

Oral Solution

15 ml.

Loxapine

Oral Liquid Concentrate

15 ml.]

___________________________

1. Ins. by G.S.R. 796(E), dated 1st October, 1992 (w.e.f. 1-10-1992).

2. Ins. by G.S.R. 753(E), dated 4th November, 1999 (w.e.f. 4-11-1999).

1[SCHEDULE Q

(See rules 134 and 144)

2[PART I]

3[LIST OF DYeS, COLOURS AND PIGMENTS PERMITTED TO BE USED IN COsMETICS AND SOAPS AND GIVEN UNDER IS : 4707

(PART I)-1988

(AS AMENDED BY THE BUREAU OF INDIAN STANDARDS)

Common Name of the Colour

Colour Index Number

Chemical Names the Colour

1

2

3

Guinea Green B

42085

Monosodium salt of 40-N-ethyl-p-sulfo-benzylamino)-diphenylmethylone-(1-(N-ethyl- Np-sulfoniumbenzyl) *2, 5-cyclohexadienimine)

Light Green SF Yellowish

42095

Disodium salt of 4-[4-(N-ethyl-p-sulfobenzylamino)-phenyl) 4-sulfoniumphenyl) methylenel]-(-N-ethyl-N-sulfobenzyl) *2, 5-Cyclohexadienimine.

Tartrazine

19140

Trisodium salt of 3-carboxy-5-hydroxy-1-p-sulfophenyl 4-  p-sulfophenylazo-pyrazole.

Sunset Yellow FCF

15985

Disodium salt of 1-p-sulfophenylazo-2-naphthol-6-sulfonic acid.

Ponceau 3R

16155

Disodium salt of a mixture of 1-alkylphenylazo-2-naphthol-3, 6-disulfonic acids.

Amaranth

16185

Trisodium salt of 1-(4-sulfo-1-napthylazo)-2-naphthol 3, 6-disulfonic acid.

Erythrosine

45430

Disodium salt of 9-0-carboxyphenyl-6 hydroxy 2, 4, 5, 7-tetraiodo-3-isoxanthone.

Ponceau SX

14700

Disodium salt of 2-(5-sulfo-2,4-xylyl-azo)-1-naphthol-4 sulfonic acid.

Brilliant Blue FCF

42090

Disodium salt of 4-(9-4-(N-ethyl-p- sulfobenzylamino-phenyl)-(2-sulfonium-phenyl)-methylene)-(1-(N-ethyl-N-p- sulfobenzyl)-*2, 5-cyclohexadienimine).

Indigocarmine

73015

Disodium salt of 5, 5’-indigotindisulfonic acid.

__________________

1. Added by Notification No. F. 1-36/64-D, dated 17th August, 1964.

2. Renumbered as Part I by G.S.R. 11(E), dated 7th January, 1991 (w.e.f. 7-11-1991).

3. Subs. by G.S.R. 811(E), dated 14th November, 1994 (w.e.f. 14-11-1994).

Wool Violet 5 BN (Acid violet 6B)

42640

Monosodium salt of 4-(N-ethyl-p-sulfobenzylamino)-phenyl)-(4-(N-ethyl-p-

(sulfonium-benzylamine)-phenyl) methylene)-(N, N-dimethyl-*2, 5-cyclohexadienimine).

Light Green SF

42095

Calcium salt of 4-(4-N-ethyl-p-sulfobenzyl) (minophennyl)

Yellowish

 

(4-sulfonium-phenyl)-methylene), (1(N-ethyl-N-p-sulfobenzyl-) *2, 5-cyclohexadienimine).

Alizarine Cyanine

61570

Disodium salt of 1,4-bis (O-sulfo-p-toluino)

Green F

 

anthraquinone.

Quinazarine Green SS

61565

1,4-bis-(p-Tbluino)-anthraquinone.

Fast Green FCF

42053

Disodium salt of 4-(4-(ethyl-p-sulfobenzylamino)-phenyl) (4-hydroxy-2 sulphonium-phenyl) methylene)-(1-N-ethyl-N-p-sulfobenzyl) * 2, 5,-cyclohexadieni-mine)

Acid Fast Green

42100

Monosodium salt of (4-(4-(N-ethyl-p-sulfobenzylamino) phenyl)-(O-chlorophenyl)-methylene)-1-(N-ethyl-N

-p-sulfonium-benzyl- * 2, 5-cyclohexdadienimine).

Pyranine Concentrated

59040

Trisodium salt of 10-hydroxy-3,5,8-pyrenetrisulfonic acid.

Quinoline Yellow WS

47005

Disodium salt of disulfonic acid of 2-(2-Quinolyl)-1,3-indandione

Quinoline Yellow SS

47000

2-(2-quinolyl)-1, 3 indandione.

Poneoeau 2 R

16150

Disodium salt of 1-xylylazo-2-naphthol-3,6-disulfonic acid.

Lithol Rubin B

15850

Monosodium salt of 4-(0-sulfo-p-tolylazo) 3-hydroxy-2-naphthoic acid.

Lithol Rubin BCA

15850

Calcium salt of 4-(0-sulfo-p-tolylazo) 3-hydroxy-2-naphthoic acid.

Lake Red D

15500

Monosodium salt of 1-0-carboxyphenylazo-2-naphthol.

Lake Red DBA

15500

Barium salt of 1-0-carboxyphenylazo-2-naphthol.

Lake Red DCA

15500

Calcium salt of 1-0-carboxyphenylazo 2-naphthol.

Toney Red

26100

l-p-phenylazophenylazo-2-naphthol.

Oil Red OS

26125

l-Xylylazaxylylazo-2-naphthol.

Tetrabromofluoresoein

45380

2,4,5,7 Tetrabromo-3,6 fluroandiol

Eosin TS

45380

Disodium salt of 2,4,5,7-tetrabromo-9-0-carboxyphenyl-

6-hydroxy-3-isoxanthone.

Eosin YSK

45380

Dipotassium salt of 2,4,5,7-tetrabromo-9-0-carboxyphenyl-6

-hydroxy-3-isoxanthone.

Tetrachlorofluorescein NA

45366

2,4,5,7-tetrachloro-S, 6-Flurcandiol

Tetrachlorofluorescein K

45366

Disodium salt of 9-0-carboxyphenyl 2,4,5,7-tetrachloro-6-

hydroxy-3-isoxanthone.

Tetrachloro Tetrabromofluorexcien

45410

2,4,5,7-Tetrabramo-12,13,14,15-tetrachloro-3, 6-fluorandiol.

Phlaxine B

45410

Disodium salt of 2,4,5,7-tetrabromo-9-(3,4,5,6-tetrachloro-o-carboxyphenyl)-

6-hydroxy-3-isoxanthone.

Bluish Orange T.R.

45457

1,4,5,8,15,-Pentabromo-2,7-dicarboxy-3,6- fluorandiol.

Helindone Pink CN

73360

5, 5’-Dichloro-3,3-dimethyl-thioindigo

Brilliant Lake Red R

15800

Calcium salt of 3-hydroxy-4phenylazo-2-naphthoic acid.

Deep Maroon (Fanchon Maroon)

15880

Calcium salt of 4-(1-sulfo-2-napthylazo)-3-hydroxy-2-naphthoic acid. _

Toluidine Red

12120

1-(o-Nitro-p-tolylazo)-1-naphthol.

Flaming Red

12085

1-(o-Chloro-p-nitrophenylazo)-2-naphthol.

Deep Red (Maroon)

12350

3-Hydroxy-N-(m-nitrophsnyl)-4-(o-nitro-p-tolylazo)-2-napthamide

Alba Red

13058

o-(p-B,B’-Dihydroxy-diethylamino)-phenylazo)-benzoic acid.

Orange G

16230

Disodium salt of 1-phenylazo-2-napthol- 6-8-disulfonic acid.

Orange II

15510

Monosodium salt on 1-p-sulfophenylazo-2-naphthol.

Dichlorofluorescein

45365

4,5,-Dichloro-3, 6-fluorandiol

Dichlorofluorescein NA

45365

Disodium salt of 9-o-carboxyphenyl-4,5-dichloro-6-hydroxy-

3-isoxanathone.

Diiodofluorescein

45425

4,5,-Diiodo-3,6-fluorandiol.

Erythrosine Yellowish NA

45425

Disodium salt of 9-o - carboxyphenyl-6-hydroxy-4,5 diiodo-3-isoxanthone.

Erythrosine Yellowish K

45425

Dipotassium salt of 9-o-carboxyphenyl-6-hydroxy 

4,5-diiodo-3-isoxanthone.

Erythrosine Yellowish NH

45425

Dipotassium salt of 9-o-carboxyphenyl-6-hydroxy-4,5-diiodo-3-isoxanthone.

Orange TR

45456

4,5,15-Tribromo-2,7-dicarboxy-3,6 -fluorandiol.

Alizarin

58000

1,2-Anthraquinonediol.

Dibromodiiodofluorescein

45371

4,5-Dibromo-2,7-diiodo-3,6-fluorandiol.

Resorcin Brown

20170

Monosodium salt of 4-p-sulfophenylazo-2-(2,4,xylylazo)-1,3-resorcinol.

Alphazurine EG

42090

Diammonium salt of 4-(N-ethyl-p-sulfobenzylamino)-phenyl)-(2-sulfoniumphenyl)-

methylene)-(1-(N-ethyl-N-p-sulfobenzyl)- *2, 5-cyclohexadienimine).

Alizarin Astrol B

61530

Monosodium salt of 1-methylamino-4-(o-sulfo-p-toluino)-anthroquinone.

Indigo

73000

Indigotin.

Patent Blue NA

42052

Monosodium salt of 4-(4-(N-ethyl-benzylamino)-phenyl)-

5-hydroxy-4-sulfoniumphenyl-methylene) (N-ethyl-N-Benzyl 

*2, 5- cyclohexadienimine).

Patent Blue CA

42052

Calcium salt of 4-(4-(N-ethyl-benzylamino) -phenyl)-(5-hydroxy-4-sulfo-2-sulfoniumphenyl-methylene)-(N-ethyl-N-Benzyl *2,-5-cyclohexadienimine.

Carbanathrene Blue

69825

3,3-Dichloroindanthrene.

Naphthol Blue Black

20470

Disodium salt of 8-amino-7-p-nitrophenylazo 

3-phenylazo-1-naphthol 3, 6-disulfonic acid.

Alizurol Purple SS

60725

1-hydraxy-4-p-toluino-anthraquinone.

Acid Red 89

23910

 

Acid Red 97

22890

 

Acid Blue 1

42045

 

Food Blue 3

42045

 

Natural Orange 6

75480

 

Solvent Blue 4

44045

 

Solvent Yellow 18

12740

 

Food Yellow 12

12740

 

Solvent Red 1

12150

 

Solvent Yellow 32

48045

 

 

 

 

Fanchon Yellow (Hansa Yellow G)

11680

a)-(O-Nitro-p-tolylazo) acetoacetanilide.]

1[PART II

LIST OF COLOURS PERMITTED TO BE USED IN SOAPS

Common Name of the Colour

Colour Index Number

Chemical Names the Colour

Phthalocyanine Blue

74160

(phthalocyaninate (2-) copper.

Iragalite Rod CVPB

12075

1-(2, 4-dinithro phenylazo)-2-Naphthalenol.

Paste or Pigment

 

 

Orange 5

 

 

Citrus Red No. 2

12156

1-2(2, 5-dimethoxy phenylazo) 2-naphthol.

Rhodamine B 500

45170

3-ethochloride of 9-0 carboxy-ethenyl-6-diethylamino-3-ethylamine-3-isoxanthene.

Aqueous Green Paste

74260

Polychlor copper Phthalocyanine.

Pigment Yellow 3

11710

2-(4-Chloro-2-nitrophenyl)-azo-N-

(-2-Chlorophenyl)-3-Oxobutamide.

Irgalite Carmine F-P Powder or Pigments Red 5

12490

N-(5-Chloro-2, 4-Dimethoxy-phenyl)-4-(CS-diathylamine) Sulfonyl-2-methoxyphenyl)-azo-3-hydroxy-2-naphthalene carboxamide.

Monolite Red 4R HV Paste or Pigment Red 7

12420

N-(4-Chlcro-2-methylphenyl-4-(4-Chloro-2-methylphenyl) azo 3-hydroxy-2-naphthalanol Carbaxamice.

Oil Red No. 1 or Solvent Red 24 or Oil Red 3R

26105

4-0-Tolylazo-Toluidine azo 2-naphthalenol.

[This list of colours for use in soaps is in addition to those colours already given in schedule Q and are used for soaps.]

2[SCHEDULE R

(See rule 125)

Standards for Condoms made of rubber latex intended for single use and other mechanical contraceptive

I. Condoms

1. Description-

Condoms consist of cylindrical rubber sheaths with one end open. The open end shall terminate with an integral rim. The closed end may have a receptacle. They may be supplied rolled and shall be free from tackiness and shall be capable of being unrolled readily.

__________________________

1. Ins. by G.S.R. 11(E), dated 7th January, 1991 (w.e.f. 7-1-1991).

2. Added by Notification No. 1-28/65-D, dated 8th March, 1966 and subs. by G.S.R. 495 (E), dated 9th June, 1995 (w.e.f. 9-6-1995).

2. Materials-

 (1) Condoms shall be manufactured from good quality rubber latex and shall be free from embedded grit and shall be opaque or translucent prior to the application of dusting materials or lubricants;

(2) The rubber latex, colours used and any dusting materials or lubricants applied to the condoms shall neither contain nor liberate substances which are known to have toxic or other harmful effects under normal conditions of use. Any dusting material or lubricant or colour used shall not have deleterious effect on the condoms or be harmful to the users.

3. Procedure for sampling during production-

(1) Specimens constituting the test samples shall be taken at random successively from each quantum of production that is, from the quantity produced from the same finished rubber latex and under the same processing and finishing conditions of manufacture and samples from each quantum shall be tested separately to ascertain conformity of quantum with the specified requirements in accordance with the tests described in this Schedule.

(2)     (a) The number of samples drawn from each quantum shall not be less than 0.5 per cent of the number.

(b) The number of samples drawn from each quantum shall be tested for Burst Volume and Pressure Test and Water Leakage Test in accordance with the method prescribed in paras 9 and 10 of this Schedule; 75 per cent of the samples drawn will be tested for Water Leakage Test and 25 per cent will be tested for Burst Volume and Pressure Test;

(c) The number of test samples 'N' and the number of rejected samples 'R' from a sequence of production quanta shall be recorded in a register. The cumulative total of test samples 'N' and the cumulative total of rejects 'R' from the test shall be recorded and the condoms shall be deemed to comply with the requirements if the cumulative total of rejects 'R' is not more than 1[0.0025N + 3 x 0.0025N] for Water Leakage Test, and 1[0.01N + 3 x 0.01 N] for Burst Volume and Pressure Test.

(3) Each unit of 100 test samples shall be distributed for the various tests as follows:-

25 for Burst Volume Pressure Test, and;

75 for Water Leakage Test.

(4) Where the number of test samples is a multiple of 100 the distribution scale mentioned above shall be prorated.

(5) If the cumulative total of samples rejected exceeds the number of allowables at any point in the sequence of quanta, the quantum at which this occurs shall be liable to rejection. The assessment of quality of further production quanta shall include all previous test results starting from Quantum Number 1 and approval of production shall be in suspense until the condition required by the scheme is again fulfilled.

(6) At least one sample shall be taken at random from each production quantum not exceeding 10,000 condoms and shall satisfy all requirements regarding dimensions as specified in paragraph 8 of this Schedule.

4. Procedure for sampling and testing of finished products by a manufacturer.-

(A) Water Leakage Test-

(1) Statistical sampling for quality control assessment of the finished product in respect of water leakage test shall be done in accordance with the plant set out in Annexure I to this Schedule.

(2) A test sample failing in the above test is to be considered as defective. If the cumulative total of rejects 'R' is found to be equal to or greater than the number shown against 'R' in Annexure-I, the batch or lot shall be declared as not of standard quality.

____________________

1. Subs. by G.S.R. 353(E), dated 26th April, 2000 (w.e.f. 26-4-2000).

(B) Bursting Volume and Pressure Test-

(1) Sample condoms shall be tested for Bursting Volume and Pressure Test. Statistical sampling for this test shall be done in accordance with the plan set out in Annexure III to this Schedule.

Condom shall not leak or burst at a volume of less than that specified or at a pressure less than 1.0 kpa (guage), when tested as per paragraph 9, both before and after oven conditioning as specified in Annexure V. Bursting Volume minimum limit in litres 

[mean condom width (mm)2]  

 

__________________

shall be equal to rounded to the nearest 0.5 litre.

151.8

(2) A test sample failing in the above test is to considered defective. If the cumulative total of rejects 'R' is found to be equal to or greater than the number shown against 'R' in Annexure III, the batch or lot shall be declared as not of standard quality.

(C) Dimensions-

At least two samples from the lot or batch shall satisfy the requirements regarding dimensions as specified in paragraph 8 of this Schedule.

5. Procedure for sampling and testing of condoms by a purchaser.-

(A) Water Leakage Test.-

(1) Statistical sampling of condoms by a purchaser for Water Leakage Test shall be done in accordance with the pant set out in Annexure II to this Schedule.

(2) A test sample failing in the above test is to be considered as defective. If the cumulative total of rejects 'R' is found to be equal to or greater than the number shown against 'R' in Annexure-II, the batch or lot shall be declared as not of standard quality.

(B) Bursting Volume and Pressure Test.-

(1) Sample condoms shall be tested for Bursting Volume and Pressure Test. Statistical sampling for this test shall be done in accordance with the plan set out in Annexure III to this Schedule. If the cumulative total of rejects 'R' is found to be equal to or greater than the number shown against 'R' in Annexure-III, the batch or lot shall be declared as not of standard quality.

Condom shall not leak or burst at a volume of less than that specified or at a pressure less than 1.0 kpa (guage), when tested as per paragraph 9, both before and after oven conditioning as specified in Annexure V. Bursting Volume minimum limit in litres shall be equal to (mean condom with (mm)2) rounded to the nearest 0.5 litre. 151.8

(C) Dimensions.-

At least two samples from the lot or batch shall satisfy the requirements regarding dimensions as specified in paragraph 8 of this Schedule.

6. Sampling plan for a Drugs Inspector-

(1) Where an Inspector under the Act desires to take for test samples from the premises of manufacturer or a distribution depot; twenty containers from each batch of production may be selected by him on a random basis and from each of the containers, five samples shall be taken. The hundred samples so selected shall be distributed for various tests as specified in paragraph 7 of this Schedule. In case, the number of containers is less than twenty, the number of samples to be taken from each container shall be proportionately increased.

(2) Where an Inspector under the Act, desires to take samples from a sale premises, he shall take hundred samples from each batch of production in accordance with the procedure as specified in sub-paragraph (1).

7. Sampled condoms drawn under sub-paragraph (1) shall be distributed for the various tests as follows:-

Two samples for thickness, length and width;

Forty five samples for Water Leakage Test;

Forty five samples for Bursting Volume and Pressure Test; and

Eight samples as reserve.

The samples shall be declared as not of standard quality, if : (i) the number of condoms found defective in the Water Leakage Test exceeds one; (ii) the number of condoms found defective in Bursting Volume and Pressure Test exceeds two; (iii) samples fail to conform to the requirements of dimensions as specified in paragraph 8 of this Schedule.

8. Dimensions-

(1) The length when unrolled (excluding test) shall be not less than-

(i) 170 mm

(ii) 180 mm

(2) The width of a condom when laid flat and measured at any point within 85 mm from the open end shall be :

(i) 49 + 2 mm for 170 mm length

(ii) 53 + 2 mm for 180 mm length

(3) The single wall thickness of a condom when measured at three points, one at 30 + 2 mm from the open end, 30 + 5 mm from the close and excluding the reservoir tip and at the mid distance between these two point shall be from 0.045 mm to 0.075 mm.

Note 1.-The single-wall thickness shall be determined with a suitable micrometer dial guage graduated in intervals of 0.01 mm.

Note 2.-Condoms shall, prior to the measurements of thickness, have the dusting powder or the lubricant or both removed by means of water or Isopropanol.

9. Bursting Volume and Pressure Test-

Determination of Bursting Volume and Pressure Test shall be done as specified in Annexure IV.

10. Water Leakage Test-

Unroll the condom and fit the open end on a suitable mount, the condom thus being suspended open end upwards. Fill it with 300 ml water at room temperature and inspect it after a period of least 1 minute for leakage upto 25 mm from the open end. If raise the closed end until water level reaches this distance. After atleast 1 minute inspect the newly-wetted part of the condom for leakage. The condom shall be deemed to be defective if it bursts during test or shows any evidence of leakage or seepage or micro-droplets or does not hold 300 ml. water.

11. Quantity of Lubricant-

(1) The condoms shall be dressed with silicone lubricant. The quantity required on each individual condom should not be less than 200 gm. and the minimum viscosity shall be 200 centistokes.

(2) Lubricated condoms in individual foil packages shall be weighed on an Analytical Balance. Each condom shall be removed from its foil package and both condom and its foil package shall be washed in denatured ethanol or isopropanol, dried and then weighed again. All weights shall be recorded to the nearest milligram (mg). Compliance with the requirement shall be determined by subtracting the weight of the washed and dried condom and its foil package from the weight of the sample condom in individual foil package prior to the removal of lubricant. Washing and drying may be repeated upto a total of four times if the lubricant quantity is less than the required minimum.

(3) At least thirteen samples shall be drawn from the lot or batch and the samples shall satisfy the requirements regarding the quantity of lubricant.

12. Colour Fastness-

Not less than ten samples taken at random from each batch of coloured condoms shall pass the following test for colour fastness, namely:-

Thoroughly wet inside and outside of the condom with distilled water. Make no attempt to remove any dusting material or lubricant. Wrap the wet condom in white absorbent paper so that the largest possible surface area of the condom is in contact with the paper and seal the whole in a suitable container to prevent loss of moisture. Allow the container and its contents to stand for 16 hours to 24 hours at room temperature. After removing the absorbent paper from the container, examine it visually in natural day-light for any indication of staining. No part of the absorbent paper shall be stained. If there is any indication of staining of the absorbent paper by any colouring agent present in any of the condoms or any dusting material or lubricant, the entire batch shall be declared to be not of standard quality.

13. Labelling, packing and storage-

(1) The condoms shall be individually wrapped and sealed in laminates containing atleast eight microns of aluminium foil. The individual condom shall be packed in square (non-squeeze condition)/rectangular aluminium foil. The packing shall protect the condoms from contamination and mechanical damage. The smallest packing offered to the consumer shall bear a clear permanent marking with the following particulars, namely:-

(i) Manufacturer's name and address and the trade name of the condoms, if any;

(ii) Batch number;

(iii) Date of manufacture (Month and year only);

(iv) Date of expiry (Month and year only) which shall not be more than thirty six months from the date of manufacture;

(v) The words "For single use only"

(2) The condoms shall be stored in a cool dry place away from heat and direct sunlight.

14. Integrity of individual package seals-

Sample condoms in individual packages shall be placed in a sealed, transparent container (such as laboratory Bell jar) and subjected to vacuum of 50 + 10 kpa (gauge) for a period of one minute.

Condom packages that do not inflate or remain inflated for the period of the test shall be deemed non-compliers. In doubtful cases, the test may be repeated, and both the inflation and deflation of packages may be observed on application and removal of vacuum. An AQL of 2.5 per cent will be applied in assessing the results of this test. Thirty-two samples of condoms for a batch size less than 5 lakhs and fifty samples of condoms for batch size more than 5 lakhs shall be tested for integrity test of individual package seals and the compliance limit or acceptance number shall be not more than two or three condoms respectively.

II. Other Mechanical Contraceptive

15. Standards for other mechanical contraceptive-

Standards for 'Copper T' and 'Tube Ring' shall be as laid down in Annexure VI.

1[ANNEXURE I

(See paragraph 4.A)

Sampling Plan for Quality Control of Condoms at Manufacturers Level

Sample Size 200 :

AQL

AC

R

--

--

--

0.25

1

2

 

BATCH SIZE : 150001 to 5 LAKHS

Single Sampling Plan

 

 

 

Sample Size 315:

AQL

AC

R

--

--

--

0.25

2

3

 

BATCH SIZE : OVER 5 LAKHS

Single Sampling Plan

 

 

Sample Size 500 :

AQL

AC

R

--

--

--

0.25

3

4

Note.-AQL denotes Acceptance Quality Level:

AC denotes Acceptance Number i.e., the maximum allowable number of defectives for acceptance of the Batch; and

R denotes Rejection Number i.e., minimum number of defectives for rejection of the Batch.

_______________________

1. Subs. by G.S.R. 353(E), dated 26th April, 2000 (w.e.f. 26-4-2000).

ANNExURE II

(See paragraph 5.A)

Sampling Plan for Quality Control of Condoms at Purchaser's Level

BATCH SIZE : 35001 to 1.5 LAKHS

Single Sampling Plan

Sample Size 200 :

AQL

AC

R

--

--

--

0.25

1

2

BATCH SIZE : 150001 to 5 LAKHS

Single Sampling Plan

Sample Size 315 :

AQL

AC

R

--

--

--

0.25

2

3

BATCH SIZE : OVER 5 LAKHS

Single Sampling Plan

 

 

 

Sample Size 500 :

AQL

AC

R

--

--

--

0.25

3

4

Note.-AQL denotes Acceptance Quality Level :

AC denotes Acceptance Number i.e., the maximum allowable number of defectives for acceptance of the Batch; and

R denotes Rejection Number i.e., minimum number of defectives for rejection of the Batch.

ANNEXURE III

(See paragraphs 4.B and 5.B)

Sampling Plan for Bursting Volume and Pressure Test

BATCH SIZE : 35001 to 1.5 LAKHS

Single Sampling Plan

 

 

 

Sample Size 200 :

AQL

--

1.5

 

AC

--

7

 

R--

8

 

BATCH SIZE : 150001 to 5 LAKHS

Single Sampling Plan

 

 

 

Sample Size 315 :

AQL

--

1.5

 

AC

--

10

 

R

--

11

 

BATCH SIZE : OVER 5 LAKHS

Single Sampling Plan

 

 

 

Sample Size 500 :

AQL

--

1.5

 

AC

--

14

 

R

--

15

Note.-AQL denotes Acceptance Quality Level :

AC denotes Acceptance Number i.e., the maximum allowable number of defectives for acceptance of the Batch; and

R denotes Rejection Number i.e., minimum number of defectives for rejection of the Batch.]

ANNEXURE IV

(See paragraphs 9)

Determination of Bursting Volume and Pressure

1. Principle-Inflation of a constant length of the condom with air and recording the volume and pressure at the moment of bursting.

2. Apparatus- 

1) Apparatus suitable for inflating the condom with clean air at a specified rate and provided with equipment for measuring volume and pressure.

(2) Suitable mount for fitting the condoms to the apparatus as shown in the figure annexed.

(3) Rod, 140 mm in length having a smooth sphere 20 mm in diameter at its top (see the figure) for hanging the unrolled condom when fixed to the apparatus.

3. Procedure- 

(1) Unroll the condom, hang it on the rod (2.3), affix to the mount (2.2) and inflate with air at a rate of 0.4 to 0.5 litre/Sec (24 to 30 litres/min.).

(2) Measure and note the Bursting Volume, in litres rounded to the nearest 0.5 litre and the bursting pressure, in kilopascals rounded to the nearest 0.1 kpa.

4. Test report-

The test report shall include the following particulars :

(a) the identification of the sample;

(b) the Bursting Volume and Bursting Pressure of each tested condom;

(c) the date of testing.

ANNEXURE V

[(See paragraphs 4(B) and 5(B)]

Oven Conditioning

1. Principle of the Method-

The test consists in subjecting test samples to controlled deterioration by air at an elevated temperature and at atmospheric pressure after which Burst Volume and Pressure limits are measured.

2. Apparatus-

The air oven shall be of such a size that the total volume of the test samples does not exceed 10 per cent of the free air space of the oven. Provision shall be made for slow circulation of air in the oven of not less than three changes and not more than ten changes per hour. The temperature of the oven shall be thermostatically controlled so that the test samples are kept within + 2oC of the specified ageing temperature. A thermometer shall be placed near the centre of the ageing test samples to record the actual ageing temperature.

Note.-Copper or Copper alloys shall not be used for the material of construction of the oven prescribed.

3. Test Sample-The foil laminations of individual packages should remain intact throughout all laboratory handling including over conditioning.

4. Temperature of the oven-Maintain the oven at 70 + 2oC.

5. Duration of test-96 Hours.

6. Procedure-

Condition the requisite number of unopened packages of rubber condoms in the oven at 70 + 2oC for 96 Hrs. After heating, keep the packages 23 + 5oC for atleast 12 hours but not more than 96 Hours. Open the packages and examine conditioned condoms for tackiness, brittleness, or other signs of deterioration. Within 96 hours but not sooner than 12 hours after conditioning, do the Bursting Volume and Pressure Test as described in this Schedule.

ANNEXURE VI

(See paragraph 15)

1. Standards for Copper T (200B) (IS-12418) (Part 4)-1991-UDC 615.477.87-Contraceptive Device Copper T (200 B) shall conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards.

2. Standards for Contraceptive Tubal Ring (IS 13009:1990-UDC 615.472.6:611.656)-Contraceptive Device Tubal Ring shall conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards.]

1[SCHEDULE R1

(See rules 109A and 125A)

The following medical devices shall conform to the Indian Standards specification laid down from time to time by the Bureau of Indian Standards:-

(1) Sterile Disposable Perfusion sets for single use only (Sections 2 and 3 of item 1 of IS 9824 : 1981 read with Amendment number 1).

(2) Sterile Disposable Hypodermic Syringes for single use only (IS 10258 : 1982).

(3) Sterile Disposable Hypodermic Needles for single use only (IS 10654 : 1991).]

2[SCHEDULE S

(See rule 105A)

STANDARDS FOR COSMETICS

Standards for cosmetics in finished form-The following cosmetics in finished form shall conform to the Bureau of Indian Standards (BIS) specifications laid down from time to time by the 3[Bureau of Indian Standards (BIS)].

1. Skin Powders

2. Skin Powder for infants

3. Tooth Powder

4. Tooth Paste

5. Skin Creams

6. Hair Oils

7. Shampoo, Soap-based

8. Shampoo, Synthetic-Detergent based

9. Hair Creams

10. Oxidation hair dyes, Liquid

11. Cologne.]

4[12. Nail Polish (Nail Enamel)

13. After Shave Lotion

_____________________

1. Ins. by G.S.R. 109 (E), dated 22nd February, 1994 (w.e.f. 22-2-1994).

2. Omitted by G.S.R. 1098, dated 9th July, 1976, (w.e.f. 24-7-1976) and ins. by G.S.R. 510(E), dated26th July, 1982 (w.e.f. 26-7-1982).

3. Subs. by G.S.R. 673 (E), dated 27th October, 1993 (w.e.f. 27-10-1993).

4. Ins. by G.S.R. 731 (E), dated 23rd August, 1990 (w.e.f. 23-8-1990).

14. Pomades and Brilliantines

15. Depliatories chemicals

16. Shaving Creams

17. Cosmetic pencils

18. Lipstick]

1[19. Toilet Soap

20. Liquid Toilet Soap

21. Baby Toilet Soap

22. Shaving Soap

23. Transparent Toilet Soap]

2[24. Lipsalve, IS: 10284

25. Powder Hair Dye, IS: 10350

26. Bindi (Liquid), IS:10998

27. Kum Kum Powder, IS:10999

28. Henna Powder, IS:11142]

3[29. Bathing Bars IS: 13498:1997]

4[SCHEDULE T

(See Rule 157)

GOOD Manufacturing PRACTICES FOR AYURVEDIC

SIDDHA AND UNANI MEDICINES

The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and Part II to ensure-

(i) Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.

(ii) The manufacturing process is as has been prescribed to maintain the standards.

(iii) Adequate quality control measures are adopted, and

(iv) The manufactured drug which is released for sale is of acceptable quality.

(v) To achieve the objectives listed above, each licencee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, under IMCC Act, 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of Good Manufacturing Practices (GMP).

PART I

GOOD MANUFACTURING PRACTICES

1.1 Factory Premises:

The manufacturing plant should have adequate space for :-

(i) Receiving and storing raw material

(ii) Manufacturing process areas

________________________

1. Ins. by G.S.R. 673 (E), dated 27th October, 1993 (w.e.f. 27-10-1993).

2. Ins. by G.S.R. 553 (E), dated 20th July, 1995 (w.e.f. 20-7-1995).

3. Ins. by G.S.R. 592(E), dated 13th August, 2008 (w.e.f. 13-8-2008).

4. Subs. by G.S.R. 560(E), dated 7th March, 2003 (w.e.f. 7-3-2003). Earlier Schedule T was added by Notification No. 1-23/67D, dated 2nd February, 1970.

(iii) Quality control section

(iv) Finished goods store

(v) Office

(vi) Rejected goods/drugs store

1.1 General Requirements:

1.1(A) Location and surroundings.-The factory buildings for manufacture of Ayurveda, Siddha and Unani medicines shall be so situated and shall have such construction as to avoid contamination from open sewerage, drain, public lavatory or any factory which produces disagreeable or obnoxious odour or fumes or excessive soot, dust or smoke.

1.1(B) Buildings.-The building used for factory shall be such as to permit production of drugs under hygienic conditions and should be free from cobwebs and insects/rodents. It should have adequate provision of light and ventilation. The floor and the walls should not be damp or moist. The premises used for manufacturing, processing, packaging and labelling will be in conformity with the provisions of the Factory Act. It shall be located so as to be:

(I) Compatible with other manufacturing operations that may be carried out in the same or adjacent premises.

(II) Adequately provided with working space to allow orderly and logical placement of equipment and materials to avoid the risk of mix up between different drugs or components thereof and control the possibility of cross contamination by other drugs or substances and avoid the risk of omission of any manufacturing or control step.

(III) Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disinfection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean. The flooring shall be smooth and even and shall be such as not to permit retention or accumulation of dust or waste products.

(IV) Provided with proper drainage system in the processing area. The sanitary fitting and electrical fixtures in the manufacturing area shall be proper and safe.

(V) Furnace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient care should be taken to prevent flies and dust.

(VI) There should be fire safety measures and proper exits should be there.

(VII) During space.-There be separate space for drying of raw material, in process medicine or medicines require drying before packing. This space will be protected from flies/insects/dusts etc., by proper flooring, wire-mach window, glass pans or other material.

1.1(C) Water Supply.-The water used in manufacture shall be pure and of potable quality. Adequate provision of water for washing the premises shall be made.

1.1(D) Disposal of waste.-From the manufacturing sections and laboratories the waste water and the residues which might be prejudicial to the workers or public health shall be disposed off.

1.1(E) Container's cleaning.-In factories where operations involving the use of containers such as bottles, vials and jars are conducted, there shall be adequate arrangements separated from the manufacturing operations for washing, cleaning and drying of such containers.

1.1(F) Stores.-Storage should have proper ventilation and shall be free from dampness. It should provide independent adequate space for storage of different types of material, such as raw material, packaging material and finished products.

1.1(F)(A) Raw materials.-All raw materials procured for manufacturing will be stored in the raw materials store. The manufacture based on the experience and the characteristics of the particular raw material used in Ayurveda, Siddha and Unani system shall decide the use of appropriate containers which would protect quality of the raw material as well as prevent it from damage due to dampness. microbiological contamination or rodent and insect infestation, etc. If certain raw materials require such controlled environmental conditions, the raw materials stores may be sub-divided with proper enclosures to provide such conditions by suitable cabinization. While designing such containers, cabins or areas in the raw materials stores, care may be taken to handle the following different categories of raw materials:-

(1) Raw material of metallic origin;

(2) Raw material of mineral origin:

(3) Raw material from animal source;

(4) Fresh Herbs;

(5) Dry Herbs or plant parts;

(6) Excipients etc.;

(7) Volatile oils/perfumes & flavours;

(8) Plant concentrates extracts and exudates/resins.

Each container used for raw material storage shall be properly identified with the label which indicates name of the raw material, source of supply and will also clearly state the status of raw material such as "UNDER TEST" or "APPROVED" or "REJECTED" The labels shall further indicate the identity of the particular supply in (be form of Batch No. or Lot No. and the date of receipt of the consignment.

All the raw materials shall be sampled and got tested either by the in-house Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the laboratories approved by the Government and shall be used only on approval after verifying. The rejected raw material should be removed from other raw material store and should be kept in separate room. Procedure of 'First in first out' should be adopted for raw materials wherever necessary. Records of the receipt, testing and approval or rejection and use of raw material shall be maintained.

1.1(F)(B) Packaging Materials.-All packaging materials such as bottles, jars, capsules etc. shall be stored properly. All containers and closure shall be adequately cleaned and dried before packing the products.

1.1(F)(C) Finished Goods Stores.-The finished goods transferred from the production area after proper packaging shall be stored in the finished goods stores within an area marked "Quarantine". After the quality control laboratory and the experts have checked the correctness of finished goods with reference to its packing/labelling as well as the finished product quality as prescribed, then it will be moved to "Approved Finished Goods Stock" area. Only approved finished goods shall be dispatched as per marketing requirements. Distribution records shall be maintained as required.

If any Ayurvedic, Siddha and Unani drug needs special storage conditions, finished goods store shall provide necessary environmental requirements.

1.1(G) Working space.-The manufacturing area shall provide adequate space (manufacture and quality control) for orderly placement of equipment and material used in any of the operations for which these are employed so as to facilitate easy and safe working and to minimize or to eliminate any risk of mix-up between different dines, raw materials and to .prevent the possibility of cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises.

1.1(H) Health Clothing, Sanitation and Hygiene of Workers.-All workers employed in the Factory shall be free from contagious diseases. The clothing of the workers shall consist of proper, uniform suitable to the nature of work and the climate and shall be clean. The uniform shall also include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes shall be provided. Separate provision shall be made for lavatories to be used by men and women, and such lavatories shall be located at places separated from the processing rooms. Workers will also be provided facilities for changing their clothes and to keep their personal belongings.

1.1(I) Medical Services.-The manufacturer shall also provide :-

(c) adequate facilities for first aid;

(d) medical examination of workers at the time of employment and periodical check up thereafter by a physician once a year, with particular attention being devoted to freedom from infections. Records thereof shall be maintained.

1.1(J) Machinery and Equipments.-For carrying out manufacturing depending on the size of operation and the nature of product manufactured, suitable equipment either manually operated or operated semi-automatically (Electrical or steam based) or fully automatic machinery shall be made available. These may include machines for use in the process of manufacture such as crushing, grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labelling and packing etc. To ensure ease in movement of workers and orderliness in operations a suitably adequate space will be ensured between two machines or rows of machines. These machinery and equipments have to be properly installed and maintained with proper cleaning. List of equipments and machinery recommended is indicated in Part II A.

Proper standard operational procedures (SOPs) for cleaning, maintaining and performance of every machine should be laid down.

1.1(K) Batch Manufacturing Records.-The licencee shall maintain batch manufacturing record of each batch of Ayurvedic, Siddha and Unani drugs manufactured irrespective of the type of product manufactured (classical preparation or patent and proprietary medicines). Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940). These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. These records shall be duly signed by Production and Quality Control Personnel respectively. Details of transfer of manufactured drug to the finished products store including dates and quantity of drugs transferred along with record of testing of the finished product, if any, and packaging, records shall be maintained. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale.

It should be essential to maintain the record of date, manpower, machine and equipments used and to keep in process record of various shodhana, Bhavana, burning in fire and specific grindings in terms of internal use.

1.1(L) Distribution Records.-Records of sale and distribution of each batch of Ayurveda, Siddha and Unani Drugs shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary.

The duration of record keeping should be the date of expiry of the batch. Certain category of Ayurvedic, Siddha and Unani medicines like Bhasma, Rasa, Kupi-pakva, Parpati, Sindura, Karpu/uppu/puran, Kushta, Asava-arista, etc., do not have expiry date, in contrast their efficacy increases with the passage of time. Hence, records need to be maintained upto five years of the exhausting of stock.

1.1(M) Record of Market Complaints.-Manufacturers shall maintain a register to record all reports of market complaints received regarding the products sold in the market. The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority. The Register shall also be available for inspection during any inspection of the premises.

Report of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shall also be maintained in a separate register by each manufacturer. The manufacturer shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation.

1.1(N) Quality Control.-Every licensee is required lo provide facility for quality control section in his own premises or through Government approved testing laboratory. The test shall be as per the Ayurveda, Siddha and Unani pharmacopoeial standard. Where the tests are not available, the test should be performed according to the manufacturers's specification or other information available. The quality control section shall verify all the raw materials, monitor in process, quality checks and control the quality of finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate expert. The quality control section shall have the following facilities:

(1) There should be 150 sq. feet area for quality control section.

(2) For identification of raw drugs, reference books and reference samples should be maintained.

(3) Manufacturing record should be maintained for the various processes.

(4) To verify the finished products, controlled samples of furnished products of each batch will be kept for 3 years.

(5) To supervise and monitor adequacy of conditions under which raw materials. semi-finished products and finished products arc stored.

(6) Keep record in establishing shelf life and storage requirements for the drugs.

(7) Manufacturers who are manufacturing patent proprietary Ayurveda, Siddha and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.

(8) The record of specific method and procedure preparation that is, "Bhavana" "Mardana" and "Puta" and the record of every process carried out by the manufacturer shall be maintained.

(9) The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.

(10) All raw materials will be monitored for fungal, bacterial contamination with a view to minimise such contamination.

(11) Quality control section will have a minimum of-

1[(i)     (a) Expert in Ayurveda or Siddha or Unani medicine who possess a degree qualification recognized under Schedule II of Indian Medicine Central Council Act, 1970;

(b) Chemist, who shall possess at least a Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University; and

(c) Botanist (Pharmacognosist), who shall possess at least a Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University:]

(ii) The manufacturing unit shall have a quality control section as explained under section 35(ii). Alternatively, these quality control provisions will be met by getting testing etc., from a recognised laboratory for Ayurveda, Siddha and Unani drugs; under rule 160A of the Drugs and Cosmetics Act. The manufacturing company will maintain all the records of various tests got done from outside recognised laboratory.

(iii) List of equipments recommended is indicated in Part II C.

1.2 Requirement for Sterile Product:

1.2(A) Manufacturing Areas.-For the manufacture of sterile Ayurvedic, Unani and Siddha drugs, separate enclosed areas specifically designed for the purpose shall be provided. These areas shall be provided with air locks for entry and shall be essentially dust free and ventilated with an air supply. For all areas where aseptic manufacture has to be carried out, air supply shall be filtered through bacteria retaining filters (HEPA Filters) and shall be at a pressure higher than in the adjacent areas. The filters shall be checked for performance on installation and periodically thereafter the record of checks shall be maintained. All the surfaces in sterile manufacturing areas shall be designed to facilitate cleaning and disinfection. For sterile manufacturing routine microbial counts of all Ayurvedic, Siddha and Unani drug manufacturing areas shall be carried out during operations. Results of such count shall be checked against established in-house standards and record maintained.

Access to manufacturing areas shall be restricted to minimum number of authorised personnel. Special procedure to be followed for entering and leaving the manufacturing areas shall be written down and displayed.

For the manufacturing of Ayurvedic, Siddha and Unani drug that can be sterilised in their final containers, the design of the areas shall preclude the possibility of the products intended for sterilisation being mixed with or taken to be products already sterilised. In case of terminally sterilised products, the design of the areas shall preclude the possibility of mix up between non-sterile and sterile products.

1.2(B) Precautions against contamination and mix.-

(a) Carrying out manufacturing operations in a separate block of adequately isolated building or operating in an isolated enclosure within the building.

(b) Using appropriate pressure differential in the process area.

(c) Providing a suitable exhaust system.

(d) Designing laminar flow sterile air systems for sterile products.

(e) The germicidal efficiency of UV lamps shall be checked and recorded indicating the burning hours or checked using intensity.

(f) Individual containers of liquids, and ophthalmic solutions shall be examined against black-white background fitted with diffused light after filling to ensure freedom from contamination with foreign suspended matter.

(g) Expert technical staff approved by the Licensing Authority shall check and compare actual yield against theoretical yield before final distribution of the batch.

All process controls as required under master formula including room temperature, relative humidity, volume filled, leakage and clarity shall be checked and recorded.

    _________________________

1. Subs. by G.S.R. 463(E), dated 8th July, 2005 and corrected vide corrigendum G.S.R. 705(E), dated 29-11-2005.

PART II

A. LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS

CATEGORIES OF AYURVEDIC, Siddha system of medicine

One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids and Avaleha, Paks, could also be shared for these items.

S.No.

Category of Medicine

Minimum Manufacturing space required

Machinery/equipment recommended

1

2

3

4

 

 

1200 square feet covered area with separate cabins partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required

 

1.

Anjana/Pisti

100 sq. feet

Karel/machanised/motorised kharel, End runner/Ball-Mill Sieves/Shifier

2.

Churna/Nasya/Manjan/ Lepal/Kwath Churn

200 sq. feet

Grinder/Disintegrator/ Pulverizer/Powder mixer/ sieves/shifter

3.

Pills/Vatti/Gutika Matrica and tablets

100 sq.feet

Ball Mill, Mass Mixer/Powder-mixer Granulator drier. Tablet compressing machine, pill/vati cutting machine, stainless steel trays/containers for storage and sugar-coating, polishing pan in case of sugar coated tablets, mechanised chattoo (for mixing of guggulu) where required

4.

Kupi Pakva/Kasara/parpati/ Lavana Bhasma/Satva/Sindura Karpu/Uppu/Param

150 sq. feet

Bhatti, Karahi, Stainless Steel Vessels/Patila Flask, Multani Matti/Plaster of Paris, Copper Rod. Earthen container, Gaj put Bhatti. Muffle furnace (Electrically operated) End/Edge Runner, Exhaust Fan, Wooden/ S.S. Spatula

5.

Kajal

100 sq. feet

Earthen lamps for collection of Kajal. Tipple Roller Mill, End Runner, Sieves, S.S. Patila, Filling/packing and manufacturing room should be provided with exhaust fan and ultra violet lamps

6.

Capsules

100 sq.feet

Air Conditioner, Dehumidifier, hygrometer. Thermometer, Capsule filling machine and chemical balance

7.

Ointment/Marham Pasai

100 sq.feet

Tube filling machine, Crimping Medicine/Ointment Mixer, End Runner/Mill (Where required), S.S. Storage Container S.S. Patila

8.

Pak/Avaleh/Khand/Modak/Lakayam

100 sq.feet

Bhatti section fitted with exhaust fan and should be fly proof, Iron Kadahi/S.S Patila and S.S. storage container

9.

Panak Syrup/Pravahi Kwath Manapaku

150 sq. feet

Tinctum press, exhaust fan fitted and fly proof, Bhatti section. Bottle washing machine, filter press/Gravity filter liquid filling machine, P.P. Capping Machine

10.

Asava/Aristha

200 sq. feet

Same as mentioned above. Fermentation tanks containers and Distillation plant where necessary, Filler Press

11.

Sura

100 sq. feet

Same as mentioned above plus Distillation plant and Transfer pump

12.

Ark Tinir

100 sq. feet

Maceration tank, Distillation plant, Liquid filling tank with tap/gravity Filter/Filler press Visual inspection box

13.

Tail/Ghrit Ney

100 sq. feet

Bhatti, Kadahi/S.S. Patila S.S. Storage containers, Filteration equipment, filling tank with tap/Liquid filling machine

14.

Aschyotan/Netra Malham Panir Karn Bindu, Nasabindu

100. sq. feet

Hot air oven electrically heated with thermostatic control, kettle gas or electrically heated with suitable mixing arrangements collation mill or ointment mill. tube filling equipment, mixing and storage tanks of stainless steel or of other suitable material sintered glass funnel, seitz filter or filter candle, liquid filling equipment, autoclavee.

15. Each manufacturing unit will have a separate area for Bhatti, furnaces, boilers, puta, etc. This will have proper ventilation, removal of smoke, prevention of flies, insects, dust etc. The furnace section could have tin roof. 200 sq. feet  

B. LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURER OF VARIOUS

CATEGORIES OF UNANI SYSTEM OF MEDICINES

One machine indicated for one category of medicine could be used for

the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids could also be shared for these items.

S.No.

Category of Medicine

Minimum Manufacturing space required

Machinery/equipment recommended

1

2

3

4

 

 

1200 square feet covered area with separate cabins partitions for each activity. If Ayurveda/ Siddha medicines are also manufactured in same premises an additional area of 400 sq. feet will be required

 

1.

Itrifal Triyao/majoon/Laooq/Jawarish Khamiras

100 sq. feet

Grinder/Pulverizer, Sieves, powder mixer (if required), S.S. Patilas, Bhatti and other accessories, Planter mixer for Khamiras

2.

Arq.

100 sq. feet

Dissilation Plant (Garembic) S.S. Storage Tank, Boiling Vessel, Gravity filter, Bottle Filling machine, Bottle washing machine, Bottle drier

3.

Habb(Pills) and tablets

100 sq. feet

Ball Mill, Mass Mixer/Powder-mixer Granulator drier, tablet compressing machine, pill/vati cutting machine, stainless steel trays/containers for storage and sugar coating polishing pan in case of sugar coated tablets, mechanised chattoo (for maxing of guggul) where required

4.

Sufoof (Powder)

200 sq. feet

Grinder/Pulveriser, Seives, Trays, Scoops, Powder Mixer, (Where required)

5.

Raughan (oils) (Crushing & boiling)

100 sq. feet

Oil Expeller, S.S. Patilas, Oil filter bottle, Filling machine, Bottle drier, Bhatti

6.

Shiyaf, Surma, Kajal

100 sq. feet

End runner, mixing S.S. Vessel

7.

Marham, Zimad (Ointment)

100 sq. feet

Kharal, Bhatti, End runner, Grinder, Pulveriser, Tripple Roller Mill (if required)

8.

Qars (Tab)

100 sq. feet

Grinder/Pulveriser, Seives, Powder Mixer, (Where needed) Gra-nulator, Drier, Tablet Compressing Machine, Die punches Trays, O.T. Apparatus, Balance with weights, Scoops, Sugar Coating Pan, polishing pan, Heater

9.

Kushta

100 sq. feet

Bhatti, Kharal, Sil Batta, Earthen pots

10.

Murabba

100 sq. feet

Aluminium Vessels 50-100 kgs. capacity, Gendna, Bhatti

11.

Capsule

100 sq. feet

Pulveriser, Powder Mixer, (Where needed), capsule filling machine, air conditioner, De-humidifier, Balance with weights, storage-containers, glass

12.

Sharbat & Jushanda

100 sq. feet

Tinctum Press, exhaust fan fitted, Bhatti section, Bottle washing machine, Filter Press, Gravity filter Liquid filling tank with tap/liquid filling machine, air oven electrically heated with thermostatic control, Kettle

Hot air oven electrically heated with thermostatic control, Kettle

13.

Qutoor Chasm and Marham (Eye drops, eye ointment)

100 sq. feet

 

14.

Each manufacturing unit will have a separate area for Bhatti, furnaces, boilers, putta, etc. This will have proper ventilation, removal of smoke, prevention of flies, insects, dust etc.

200 sq. feet

 

C. List of Equipment Recommended for in House quality control section

(Alternatively unit can get the testing done from the government

approved laboratory)

(A)

Chemistry section

(B) Pharmacognosy section

1.

Alcohol Determination Apparatus (complete set).

1. Microscope Binocular

2.

Volatile Oil Determination Apparatus

2. Dissecting Microscope

3.

Boiling Point Determination Apparatus

3. Microtome

4.

Melting Point Determination Apparatus

4. Physical balance

5.

Refractometer

5. Aluminium Slide trays

6.

Polarimeter

6. Stage Micrometer

7.

Viscometer

7. Camera Lucida (Prism and Mirror Type).

8.

Tablet Disintegration Apparatus

8. Chemicals, Glass-ware etc.

9.

Moisture Meter

 

10.

Muffle Furnace

 

11.

Electronic Balance

 

12.

Magnetic Stirrer

 

13.

Hot Air Oven

 

14.

Refrigerator

 

15.

Glass/Steel Distillation Apparatus

 

16.

LPG Gas Cylinders with Burners

 

17.

Water Bath (Temperature Controlled)

 

18.

Heating Mantles/Hot Plates

 

19.

TLC apparatus with all Accessories (Manual)

 

20.

Paper Chromatography apparatus with accessories.

 

21.

Sieve Size 10 to 120 with Sieve shaker

 

22.

Centrifuge machine

 

23.

De-humidifier

 

24.

pH Meter

 

25.

Limit Test Apparatus

 

1[D. Supplementary guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat

(Herbo-mineral-metallic compounds) of Ayurveda, Siddha and Unani medicines

These guidelines are intended to complement those provided above and should be read in conjunction with the parent guidelines. The supplementary guidelines are to provide general and minimum technical requirements for quality assurance and control in manufacturing Rasaushadhis or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic formulations). These supplementary guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of Metals and Minerals origin) Druti Parpam, Karpu, and Kushta etc. used in Ayurvedic, Siddha and Uaani Systems of medicine.

______________________

1. Ins. by G.S.R. 157(E), dated 4th March, 2009 read with corrigendum G.S.R. 338(E), dated 15th April, 2010 (w.e.f. 9-3-2009).

The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal and Kushtajat are needed to establish the authenticity of raw drug, minerals and metals, in-process validation and quality control parameters to ensure that these formulation are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have Good Manufacturing Practices for ASU drugs and supplementary certificate of Rasaushadhies or Rasamarunthukal and Kushtajat formulations shall be allowed to manufacture the same. Supplementary Good Manufacturing Practices certificate for Rasaushadhies shall be issued by the State Licensing Authority only after thorough inspection by an expert team including Rasashstra experts nominated by the Department of AYUSH.

2. Manufacturing Process Areas.-For the manufacture of Bhasma and Kupipakawa and Rasaushadhi preparations made from metals and minerals the following specific areas shall be provided, which should be completely segregated from the production area used for preparation of plants and animal by product based formulation to avoid cross-contamination. The following exclusive areas are required for Rasaushadhies or Rasamarunthukal and Kushtajat:-

2.2.     (a) Bhatti or Heating Devise section for Bhasma and Rasaushadhies:-100 Sq. feet for heating, burning, putta and any heat related work with proper ventilation, exhaust and chimney. This could be tin shed also.

(b) Grinding, Drying and Processing section for Bhasma and Rasaushadhies:-100 Sq. feet (Manual or Mechanical, oven etc.). Drying 1[shall be] done in a space which is covered by glass or other transparent material to allow entry of sunrays on the material to keep for the purpose. If drying is being done in oven the temperature of the same may be selected specific temperature.

(c) Rashaushadi Related Store:-100 Sq. feet.

The size and dimensions of each Bhatti section would be so designed to suit the batch size or quantity of materials to be processed, keeping in mind the processing is done as per the conditions of Drug and Cosmetics Act mentioned under Schedule I official books.

In addition to the fuels prescribed in the schedule books namely coal, fire wood, cow dung cakes etc., use of other heating devices e.g., electrical heating, oil or gas fired furnaces and others 1[shall be] employed so as to provide the required temperature as per the nature of material and object of heating. Depending on the formulation being manufactured, manufacturers may adopt aerobic or anaerobic process. Properly baked and clean earthen pots of other crucibles and glass containers or appropriate design shall be used.

The manufacturing area should be designed with special attention to process the products that generate toxic fumes like SO2 arsenic and mercury vapour, etc. When heating and boiling of the materials is necessary, suitable ventilation and air exhaust flow mechanism should be provided to prevent accumulation of unintended fumes and vapours. Such areas may be provided with properly designed chimneys or ducts fitted with exhaust system and suitable scrubbing system to remove fumes and smoke, so that safety of personnel and environment is taken care of.

Since processing of Rasaushadhis may introduce heavy metal contamination and cross-contamination etc., therefore, cleaning of equipment is particularly important after every process by using appropriate cleaning agent which should not react with material of equipment and must be free from unwanted properties e.g., corrosiveness.

2.3 Records shall be maintained specially for temperatures attained during the entire process of Bhasmikaran, while employing different kinds of classical puta, furnaces using oil, gas or electricity. Appropriate temperature measuring instrument should be employed such as pyrometer and, pyrograph for manual reading or recording by heat sensors, connected to computer as the case may be.

_____________________

1. Subs. by corrigendum G.S.R. 338(E), dated 15th April, 2010, for “may be”.

In order to handle large quantities, appropriate technology like use of hand operated extruders for making chakrikas or pellets may be adopted. However, such equipments made of aluminium or its alloys should not be used.

Access to manufacturing areas shall be restricted to minimum number of authorized personal only.

3. Quality Control.-

A. IN PROCESS QUALITY CONTROL:

The registers as indicated below should exclusively be maintained for ready reference:

(a) Shodhan Register with following details:-

1. Sl. No.

2. Batch No. and Size

3. Date, time and duration

4. Name of the Raw-material with Quality reference and quantity

5. Quantity of Shodhana Dravya

6. Book Reference followed

7. Methodology

(b) Bhavana and Putta Register with following details:-

1. Sl. No.

2. Batch No.

3. Date, time

4. Name of the material and quantity of starting materials

5. Quantity of Nirvapya Dravya

6. Quantity of Bhavana Dravya

7. Date and Time of Starting and completion of Bhavana or Mardana and duration

8. Type and Number of Puttas

9. Time and Date of completion Puttas

10. Colour and texture of the product or standards

11. In process tests followed (Bhasma Pariksha and any other tests)

12. In case heating at a particular temperature is required, record of attainment of that temperature.

(c) Grinding Record Register:-(Finished Product/Intermediate procedure)-

1. Sl. No

2. Batch No

3. Date and time

4. Name of the material and quantity

5. Name of the equipment (SS/granite)

6. Duration of grinding

7. Repeat the grinding if required (Number of repetition)

(d) Packing details-

1. Name of Rasaushadhi

2. Type of Dosage Form (e.g., Powder, pill, tablet etc.)

3. Weight of Rasaushadhi in each unit.

B. PRODUCT QUALITY CONTROL:

The specifications for finished Rasaushadhi are primarily intended to define the quality rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the quality. Consistent quality for Rasaushdhi can only be assured if the starting material-metals and minerals are used of pharmacopoeial standards. In some cases more detailed information may be needed on aspects of their process. The manufacture will ensure in-house standards for the uniform quality of product.

Quality testing will be carried out as per official Pharmacopoeia or Schedule books for texts namely, colour, taste, varitaratwa, Rekhapurnatwa, Laghutva, Nirdhumatwa, Dutagre Kachakacha, Niruttha, Apunarbhava and Nischandratwa.

The Particle size of the product should be tested by adopting microscope fitted with micrometer or particle size analyzer or any appropriate other techniques. Required physio-chemical characterization of the product should be undertaken by appropriate analytical equipment. The Standard Manufacturing Process of the product should be evolved/follow up. The disintegration time of pills-vati and tablets should also be recorded.

4. Product recalls.-Literature inserted inside the product package should indicate the name address of the manufacturing unit 1[and] telephone number for reporting of any adverse drug reaction by physicians or patients. On receipt of such Adverse Drug Reaction report, it will be the responsibility of the manufacturer to ensure the recall the product from the market.

Standard operating procedures (SOP) should be included for storage of recalled Rasaushadhies in a secure segregated area, complying with the requirements specified for storage, till their final disposal.

5. Medical examination of the employees.-Employees engaged in manufacturing should be medically examined periodically at least once a year for any adverse effect of the drug during manufacturing process for which necessary investigations 2[shall be] carried out for ensuring that there is no effect of material on the vital organs of the employees. Annual examination reports of the employees shall be made available to statutory inspectors during Good Manufacturing Practices inspections.

6. Self-Inspection.-The release of Rasaushadhis should be under the control of a person who has been trained in the specific features of the processing and quality assurance of Rasaushadhis. Personnel dealing with the production and quality assurance of Rasaushadhis manufacturing section should have an adequate training in the specific subject of Rasaushadhis manufacturing. He will be at least a degree holder in Ayurveda/Siddha/Unani medicine or B. Pharma degree holder in Ayurveda/Siddha/Unani medicine.

7. Dosage form of Rasaushadhi.-The Rasaushadhies may be made into an acceptable dosage forms such as, churna, vati, guti, tablet, capsule or Capsule etc., after adding suitable permissible fillers or binding agents as permissible under the Ayurvedic Pharmacopoeia of India or Indian Pharmacopoiea as updated from time to time. In such cases the label must indicate the quantity of Ayurveda, Siddha and Unani medicine in one Tablet or Pill or Capsule in addition to the filler. The crystalline product may be grinded before packing in the individual dispensing size". All the Rasushadhi or Rasamaruthukal or Kushtajat shall be packed in a dosage form which is ready for use for the consumer. Grinding and weighting of individual does of potentially poisonous products will not be permissible in patient consumer pack. This arrangement may reduce the Adverse Drug Reaction of Rasaushadhi which takes place due to does variation. However for hospital bulk pack, it will not be applicable and label will clearly indicate the "Hospital pack".

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1. Subs. by corrigendum G.S.R. 338(E), dated 15th April, 2010, for “or e-mail or”.

2. Subs. by corrigendum G.S.R. 338(E), dated 15th April, 2010, for “may be”.

8. Area Specifications/requirement for an applicant companies only to have GMP of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineral/metallic compounds) of Ayurveda, Siddha and Unani medicines:-

S.No.   

 Category of Medicine/Manufacturing area   

 Minimum Manufacturing Space required (1500 sq. ft.)   

 Machinery equipment recommended

 1.   

 Pisti/Grinding area for Bhasma, Pishti, Kushtajat.   

 100 sq. ft.   

 Kharal/mechanized/motorized Kharal, End runner/Ball-Mill Sieves/Shifter.

2.

 Powdering area for raw drugs of  plant origin giving in Rasaushadhies (Herbo-metalic formulations).

200 sq. ft.

Grinder/Distintegrator/Pulverisar/Powder mixer/Sieves/ Shifter

3.

Pills/Vati/Gutika Matrica and tablets/Habb making area.

100 sq. ft.

Ball Mill, Mass Mixer/Powder mixer, Granulator drier, tablet compressing machine, pill/vati cutting machine, stainless steel trays/container for storage and sugar coating, polishing pan in case of sugar coted tablets, mechanized chatee, (for mixing of guggulu) where required.

4.

Kupi pakva/Ksara/Parpati/LavanaBhasma Satva/Sindura Karpu/Uppu/Param/Qushta/Jawhar

 150 sq. ft.

Bhatti, Karahi/stainless steel vessels/patila flask, Multani Matti/ Plaster of Paris, Copper Rod, Earthen container, Gaj Put Bhatti, Muffle furnace (electrically operated) End/Edge Runner, Exhaust Fan, Wooden, S.S. Spatula.

5.

Receiving and storing raw material

200 sq. ft.

6.   

  Quality Control Section   

  150sq. ft.   

 

7.   

  Quarantine/observation   

  50 sq. ft.   

 

8.   

  Finished goods store   

  150 sq.ft.   

 

9.   

  Rejected goods store   

  50 sq. ft.   

 

10.   

  Bhatti-putta area   

  200 sq. ft.   

 

11.   

  Area for water and washing etc.   

  50 sq. ft.   

 

12.   

  Office   

  100 sq. ft.   

 

Total

1500 Sq. ft.]

Note.-The above requirements of machinery, equipments, space, are made subject to the modification at the discretion of the Licensing Authority; if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter then in the circumstances in a particular case 1[he may do so after recording reasons in writing].

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1. Added by G.S.R. 463(E), dated 8th July, 2005 and corrected vide corrigendum G.S.R. 705(E), dated 29-11-2005.

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