Regulatory issue in india for asu drugs

For B.Pharm, 6th Sem

1. Regulatory Issues in India (ASU DTAB, ASU DCC)

2. What are regulations? Legal norms for- What is required to be done for an intended purpose? How and in what manner it can be done? What can not be done for achieving the intended purpose? Penalizing the persons for committing any omission from prescribed standards or for commission of prohibited actions. Who can make, amend and enforce the provisions ?

3. Needs for Drugs Regulation • To prescribe and enforce standards for manufacturing, distribution, sale, marketing and information of drugs. • To ensure availability of quality drugs to the people. • To promote public protection from hazards/harmful effects of drugs.

4. CONDITIONS FOR COMMERCIAL MANUFACTURING OF ASU DRUGS 1. License of the manufacturing unit and intended formulations 2. GMP Compliance 3. Adequate infrastructural facility, staff, equipment, reference books, record keeping etc. 4. Compliance to Standards given in the pharmacopoeia.

5. Herbal drug regulations in India Provisions relating to the manufacture and control of Ayurvedic , Siddha and Unani (ASU) drugs have been prescribed in the Drugs and Cosmetics act. This act describes the formation of Drugs Technical Advisory Board (DTAB), which consists of various nominated members and the Drugs Consultative Committees (DCC).

6. The Ayurvedic , Siddha and Unani Drugs Technical Advisory Board (ASU-DTAB) The central government shall constitute a board by notifying in the official gazette . The board shall advice the central as well as state governments on technical matters arising out of the section 33-C & 33D of the Drugs and Cosmetic act and carry other functions assigned.

7. A. Constitution of the board The board shall consist of the following members. 1.The director general of health services, ex-officio . 2.The drugs controller, ex officio. 3.The director of Central Drugs Laboratory, Calcutta, ex officio. 4.One government analyst nominated by the central board. 5.One Pharmacognocist nominated by the central government. 6.One phytochemist nominated by the central government. 7.Four persons nominated by central government, among which two from the members of Ayurvedic pharmacopoeia committee and one each from Unani and Siddha pharmacopoeia committee. 8 . One teacher in Dravyaguna and Bhaishajya kalpana to be nominated by central government . 9. One teacher from ilmul-Advia and Taklis-wa-Dawasazi to be nominated by central government . 10. One teacher in Gunapadam to be nominated by central government. 11. Three persons, one each represent the Ayurvedic , Siddha and Unani drug industry tobenominated by central government. 12. Three persons, one each from amongst the practitioners of Ayurvedic , Siddha and Unani , Tibb systems of medicine to be nominated by central government.

8. B. Functioning of the board The central government shall appoint a chairman from amongst its members. The nominated members of the board shall hold office for three years but shall be eligible for re-nomination . The board may make bye- laws to regulate its functioning and conduct of all activities. The central government shall appoint a secretary of the board and shall provide the board with such clerical and other staff.

9. The Ayurvedic , Siddha and Unani Drugs Consultative Committee (ASU-DCC) The central government may constitute an advisory committee as mentioned in thesection33-D of the Drugs and Cosmetics act. This committee may advice thecentral and state governments and the Ayurvedic , Siddha and Unani drugs technical advisory board (ASU-DTAB) on any matter for the purpose of securing uniformity in the administration of this act (section 33-D ) throughout India.

10. Constitution and functioning of ASU-DCC The ASU-DCC shall consist of two persons nominated by central government and one person from the state government who act as representative of the respective governments . The ASU-DCC shall meet when required to do so by the central government and shall regulate its own activities as per their requirements.

11. Regulations for the manufacture of Ayurvedic , Siddha and Unani (ASU) drugs The Section 33-EEB of the Drugs and Cosmetics act describes the regulations for the manufacture and sale of ASU drugs. The act has set some standards related to the hygienic conditions, factory premises, prohibition of manufacture and sale of certain drugs and penalties for contravention of this act.

12. A. Requirements of factory premises and hygienic Conditions As per the act, it is mandatory to maintain proper hygienic conditions in the factory premises along with the following requirements. Factory or industry involved in the manufacture of ASU drugs should not be situated adjacent to open sewage, drain, public lavatory or any other factory which produces obnoxious odour, large quantities of waste, dust or smoke. The premises of manufacturing unit shall be clean, hygienic and free from insects , rodents and other contamination. Note":-All the sections fall under the Schedule-Z of the Drugs & Cosmetics Act . The walls and floor of manufacturing rooms should be smooth, easily cleanable with water and should not accumulate dust or waste products. The water used in the manufacture shall be pure and drinking quality. It should be free from pathogenic organisms.

13. Contii .. Adequate facility should be provided to process the containers and closures for washing, cleaning, drying, etc and it should be separated from the manufacturing unit. Suitable arrangements shall be provided for disposing waste water and other materials in a manner that it does not affect the health of people in the surrounding area. Personnel working in the factory should be free from contagious diseases. Appropriate dress should be provided to the workers based on the nature of their work. Adequate facilities for personal cleanliness such as soap, towel, and antiseptics should be provided. Facilities for drinking water and separate wash rooms should be provided for men and women.

14. B. Prohibition of manufacture and sale of certain ASU drugs The act prescribes some criteria to prohibit the manufacture and sale of certain ASU drugs which are not manufactured or sold in accordance of the rules. The following categories of ASU drugs can be prohibited from manufacture and sale. Any misbranded , adulterated or spurious ASU drugs. Any proprietary or patented medicine which does not display the list of all ingredients on the label of the container. The selling, stocking and distribution of any ASU drug which has been manufactured in contravention of the provisions of this act . The manufacture, sale and distribution of any ASU drugs for which license has not been issued by the prescribed authority. The above rules do not apply to vaidyas and hakims who prepared ASU drugs for the use of their own patients. The above rules do not apply to ASU drugs which are manufactured in small quantities for the purpose of examination, test or analysis.

15. C. Power of central government to prohibit the manufacture, sale &distribution of ASU drugs in public interest The section 33-EED of the Drugs and Cosmetics act prescribes certain powers of the central government based on which the government can prohibit the manufacture , sale and distribution of ASU drugs which involve any risk to humans or animals or such drug does not have therapeutic value as claimed by the manufacturer orany misbranded and spurious drugs . Hence in such circumstance, the government may prohibit the manufacture, sale &distribution of drugs in public interest.

16. D. Penalty for the manufacture, sale and distribution of prohibited ASU drugs. As prescribed under the section 33-1 of the Drugs and Cosmetics act, any person himself on his behalf is engaged in the manufacture, sale and distribution of prohibited ASU drugs , penalty has been fixed as per the following guidelines. *Any ASU drug which is deemed to be adulterated or manufactured without a valid license shall be punishable up to one year imprisonment and with fine up to 2 thousand rupees. *Any ASU drug which is deemed to be spurious shall be punishable with Imprisonment upto 1 to 3 years and with fine up to 5 thousand rupees. *Any ASU drug which contravenes any other provision of the act shall be punishable with imprisonment up to 3 months and with fine up to 500 rupees.

17. E. Manufacture on more than one set of premises The ASU drugs are manufactured on more than one set of premises, a separate application shall be made and a separate license shall be obtained for each premises .

18. Overall Regulatory Framework for ASU & H Drugs

19. References 1. V.D.Rangari . Pharmacognosy & Phytochemistry . 2.Pharmacopoeal standards for Ayurvedic Formulation (Council of Research in Indian Medicine & Homeopathy) 3 . P Mukherjee , Quality Control of Herbal Drugs: An Approach to Evaluation of Botanicals. Business Horizons Publishers, New Delhi, India, 2002. 4 . S.S Agarwal and N Paridhabi . Herbal Drug Technology. * For any regulatory/enforcement query, clarification or guidance, go to- [email protected] [email protected]