The Central Government after consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board proposes to make, in exercise of the powers conferred by clause (a) of sub-section (I) of section 33-N read with sub-section (I), clause (d) and (f) of sub-section (2) of section 6 of the Drugs and Cosmetiv

REGD. NO. D. L-33004/99

The Gazette of India

EXTRAORDINARY

PARTII— Section 3—Sub-sectioa(i)

PUBLISHED BY AUTHORITY

No. 372] NEW DELHI, WEDNESDAY, AUGUST 14, 2002/SRAVANA 23,1924

2531 GI 2002

(1)2_ _ _ „_ THE GAZETTE OF INDIA: EXTRAORDINARY ' [PART II—Sgc. 3(i)] 3 4 THE GAZETTE OF TNDIA EXTRAORDINARY [PART IT—SEC 3(I)] _J6 THE GAZETTE OF INDIA EXTRAORDINARY [PAR I II—SEC 3(Q] _j8 . _ _ ^ _ _ __ THE GAZETTE OF TNDIA EXTRAORDINARY [PAR ill—Su~ 3(Q] _9 2531 GI/2002—2]0 THE GAZETTE OF INDIA EXTRAORDINARY [PART II—SEC 3(i)j 11 12 THE GAZETTE OF INDIA EXTRAORDINARY [PAR i II—SEC 3(i>| _J214 THE GA£ETI E OF INDIA . EX1 K AORDINARY [P^irll—Sf^_3(i)l J516 ^ __ T HE G A ZE f TE OP I N D IA E X T R A O R D I N A RY [ P AX r I I —S L. • 3 ( i )j 17

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Indian Systems of Medicine and Homoeopathy)

NOTIFICATION

New Delhi, the 13th August, 2002

G.S.R 566(E):— The following draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government after consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board proposes to make, in 2531 GI/2002—318 THE GAZETTE OF INDIA: EXTRAORDINARY [PARi II—SEC. 3(i)] exercise of the powers conferred by clause (a) of sub-section (I) of section 33-N read with sub-section (I), clause (d) and (f) of sub-section (2) of section 6 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published as required by the said section for the information of all persons likely to be affected thereby and notice is hereby given that the said draft rules will be taken into consideration after the expiry of a period of 45 days from the date on which copies of the Official Gazette in which this notification is published, are made available to the public;

Objections or suggestions, if any, may be addressed to the Secretary, Department of Indian Systems of Medicine 8B Homoeopathy, Ministry of Health and Family Welfare, Indian Red Cross Society Building, New Delhi 110001;

Any objection or suggestions, which may be received from any person with respect to the said draft rules within the period specified above will be taken into consideration by the Central Government.

•

DRAFT RULES

1. These rules may be called the Drugs and Cosmetics ( Amendment) Rules, 2002.

2. They shall come into force on the lBt January, 2003.

3. In the Drugs and Cosmetics Rule, 1945,

(a) after rule 155-A, the following shall be inserted, namely: -

"155-B Certificate of award of G.M.P. of Ayurveda. Siddha and Unani Drugs: The certificate of Good Manufacturing Practices (GMP) to manufacturers of Ayurved-Siddha or Unani drugs shall be issued to licensee who comply with the requirements of Good Manufacturing Practices (GMP) of Ayurveda, Siddha and Unani drugs as laid down in Schedule T".

(b) in rule 157, after condition (1), the following shall be inserted, namely:

"(1A) For getting a certificate of 'Good Manufacturing Practices of Ayurveda- Siddha-Unani drugs, the applicant shall make an application on a plain paper, providing the information on existing infrastructure of the manufacturing unit, and the licensing authority shall after verification of the requirements as per Schedule T\ issue the certificate within a period of 3 months in Form 26E-I", (c) after Form E, the following form shall be inserted, namely:-

Form 26E-I

(See rule 167-B)

(Certificate of Good Manufacturing Practices (GMP) to manufacturer of Ayurveda, Siddha or Unani drugs):

Certified that manufacturing unit licensee, namely

, situated at State License No comply with the requirements of Good Manufacturing Practices (GMP) of Ayurveda-Siddha-Unani drugs as laid down in Schedule T of the Drugs and Cosmetic Rules, 1945.

This certificate is valid for a period of three years.

Dated:

Signature Designation/

Place:

Licensing Authority for Ayurveda/

Siddha/Unani Drugs.

(d) for Schedule "T", the following shall be substituted, namely: -

SCHBDULB T

(See rule 157)

GOOD BIANUPACTURINO PRACTICES FOR

AYURVBDIC, 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; (iv) The manufactured drug which is released for Sale is acceptable quality; (v) to achieve the objectives listed above, each licensee 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).

PARTI

GOOD MANUFACTURING PRACTICES

Factory Premises:

The manufacturing plant should have adequate space for:-

(i) receiving and storing raw material; (ii) manufacturing process areas; (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 building for manufacture of Ayurveda, Siddha and Unani medicines shall be so situated and shall have such construction as to avoid contamination from open sewrage, drain, public lavatory or any factory which produces disagreeable or abnoxious odour or fumes or excessive soot, dust or smoke.

l.l(B) Buildings:

The building used for factory shall be such as to permit production of drugs under hygenic 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 of 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 of 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 dis-infection. 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 of 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,¹ 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) Drying 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/dust etc., by proper flooring, wire-mash window, glass pans or other material.

l.l(C) Water Supply:

The water used in manufacture shall be pure and potable quality. Adequate provision of water for washing the premises shall be made.

l.l(D) Disposal of Waste:

From the manufacturing section 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 a nd j a rs are conducted, there shall be adequate arrangements separated from the manufacturing operations for washing, cleaning and drying of such containers.

l.l(F) Stores:

Storage should have proper ventilation a nd shall be free from dampness. It should provide independent adequate space for storage of different types of material, such as raw material, packaging material a nd 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 store, care may be taken to handle the following different categories of raw material:-

(4) Fresh herbs. (5) Dry herbs or plant parts. (6) Excipients etc. (7) Volatile oils/perfumes and 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 the 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 with 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.

l.l(Q) 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 drugs, 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.

l.l(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 J23 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 brushed 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(1) Medical Services:

The manufacturer shall also provide:-

(a) Adequate facilities for first aid; (b) 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.

l.l(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, labeling 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.

11.(K) Batch Manufacturing Record*

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 Cosmetic Act, 1940 (23 of 1940). These tests may include any in-house or phannacopoeial 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 Qualify 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 grinding in terms of internal use.

l.l(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 expire of the batch.

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 separate register by each manufacture; The manufacture 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.

l.l(N) Quality Control:

Every licensee is required to 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 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/ware house. 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. ft. 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 finished products of each batch will be kept for till the expiry date of product.

(5) To supervise and monitor adequacy of conditions under which raw materials, Semi-finished products and finished products are 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 reference in respect of such formulated drugs.

(8) The record of specific method and procedure of preparation, that is,25 "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 pharmacopoieas 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 minimize such contamination.

(11) Quality control section will have a minimum of

(i) One person with Ayurveda/Unani/Siddha qualification recognized under Schedule II of Indian Medicine Central Council Act 1970. Two other persons one each with Bachelor qualification in Botany/ Chemistry/ Pharmacy could be on part time or on contractual basis.

(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 recognized laboratory for Ayurveda, Siddha and Unani drugs; under Rule 160-A of the Drugs and Cosmetics Act. The manufacturing company will maintain all the record of various tests got done from outside recognized laboratory.

(ui) 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 authorized 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 sterilized in their final containers, the design of the areas shall preclude the possibility of the products intended for sterilization being mixed with or taken to be products already sterilized. In case of terminally sterilized products, the design of the areas shall preclude the possibility of mix up between non-sterile and sterile products.

2531 Gl/2002—426_ THE GAZETTE OF INDIA EXTRAORDINARY [PAKI II—SFC 3(0]

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 opthalmic 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.

PART-II

A. LIST OF RECOMMENDED 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.

B. LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING

PREMISES REQUIRED FOR THE MANUFACTURE 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.

|PARI II—SEC 3 ( I )| \) TI IE GAZETTE OF INDIA E>TI RAORDINARY

4.

200 sq. it.

Sufoof (Powdei)

n.

100 sq. tt

6.

100 sq. ft.

7.

100 sq. ft.

Kaughan (Oils) (Crushing ft, Boiling] Shiyaf, Sunn a, Kajal Marham, Zimad (Ointment)

Qurs (Tab.)

8.

100 sq. ft.

9. Kushta

100 sq. ft.

10. Murabba

100 sq. ft.

Capsule

1 1.

100 sq. ft.

12.

100 sq. ft.

Sharbat & Joshanda

100 sq. ft.

13.

steel trays/container for storage and sugar coating, polishing pan in case of sugar coated tablets, mechanized chattoo, (for mixing of guggul) where required. Grinder/Pulveriser, Sieves, Trays, Scoops, Powder mixer (where required). Oil expeller, S.S. Patilas oil filter bottle, filling machine, bottle drier, Bhatti. End runner, mixing S.S. vessel. Kharal. Bhatti, End runner, Grinder, Pulveriser, Triple roller mill (if required) Grinder/Pulveriser, Sieves, powder mixer (where needed), Granulator, Drier, Tablet compressing machine, Die punches Trays, O.T. Apparatus, Balance with weights, Scoops, Sugar coating pan, Polishing pan, Heater. Bhatti, Kharal, Sil Batta, Earthen pots. Aluminium vessels 50-100 kgs. Capacity, Gendna, Bhatti. Pulveriser, Powder mixer (where needed), capsule filling machine, Air conditioner, De- humidifier balance with weights, storage containers, glass. Tinctum press, exhaust fan fitted, bhatti section, bottle washing machine, Filter press gravity filter, Liquid filling tank with Lap/ liquid filling machine, air oven electrically heated with Thermostat ic control, kettle. Hot air oven electrically heated with Thermostauc control, kettle.

14

"iWKsq. ft.

Qutoor-e- Chashm and Marham (K\re drops Eye ointment) Each manufacturing unit will have a separate area for Rhatti, furnaces, ^

_ 1]

1 - - - - boilers, putta etc. This will have proper ventilation, removal of smoke, prevention of flies, insects, dust etc.

C. LIST OF EQUIPMENT RECOMMENDED FOR IN HOUSE QUALITY

CONTROL SECTION.

(Alternatively unit can get the testing done from the Government

approved laboratory.)

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 them in the circumstances in a particular case.

| F No. K-11020/5/97-DCCaSM) I

L PRASAD, Jt Secy Footnote: The Principal rules were published in the Official Gazelle vide notification No F. 28-10/45-H( 1), dated the 21 st December, 1945 and last amended vide GSR 5()4(E) dated 18-7-2002

Primed by the Manager, Govt of India Press, Ring Road, Mayapun, New Dclh.-l 10064 and Published by the Controller of Publications, Deihi-110054