DTAB, DCC CDL.pptx Pharmaceutical Jurisprudence

Jurisprudence

1. Administration of the Act and Rules

2. Administration of the drugs and cosmetic act and rules are divided into 3 parts. 1) Administrative part or advisory part. a) DTAB(Drug Technical Advisory Board) b) DCC (Drug Consultative Committee) 2) Analytical part. a) Central Drug Laboratory b) Drug testing laboratory of the state. c) Government analyst 3) Executive Part a) Controlling authority b) Licensing authority c) Drug inspector.

3. Drugs Technical Advisory Board (DTAB) It is a Statutory Board constituted by the Central Government under the provision of this Act to advise the Central Government and State Governments on all the technical matters related with the Act and to set in the guidelines for types of formulations as and when asked for by the Central Government. It is a technical advisory body represented by the Ex-officio, nominated and elected members.

4. The total strength of DTAB is 18 representing different facets of pharmacy and medical profession in the country. The Director General of Medical and Health Services, Government of India is the Chairman of DTAB while, Drugs Controller General of India is the Member Secretary. The Head Office of DTAB is at Ministry of Health and Family Welfare, Government of India, Nirman Bhavan, New Delhi.

5. 1. Ex-officio members: i . Director General Health Services.(Chairman) ii. Drugs Controller of India iii. Director Central Drugs Laboratory, Kolkata iv. Director Central Research Institute, kasauli . v. Director Indian Veterinary Research Institute, Izatnagar . vi. President Pharmacy Council of India vii. President Medical Council of India. viii. Director Central Drug research Institute, Lucknow.

6. 2. Nominated members: i . 2 persons nominated by central government who are in-charge of drugs control in states. ii. 1 person from the pharmaceutical industry nominated by central government. iii. 2 government analysts nominated by central government.

7. 3. Elected members. i . A teacher in Pharmacy or Pharmaceutical chemistry or Pharmacognosy of an Indian university or an affiliated college elected by the executive committee of the Pharmacy Council of India. ii. A teacher in medicine or therapeutics of an Indian University or an affiliated college elected by executive committee of Medical Council of India

8. iii.1 Pharmacologist elected by the governing body of the Indian Council of Medical Research. iv.1 person elected by the central Council of Medical Association. v. 1 person to be elected by the council of Indian Pharmaceutical Association. The nominated and elected members hold the office for 3 years. They are eligible for re-nomination or reelection.

9. The term of elected and nominated members is for 3 years. The Ex-officio members hold the office so long as they are in that specific position. The DTAB can form the sub-committees and also co-opt member experts for specific assignment even though, they are not the members of DTAB. The DTAB takes the policy decisions pertaining to technical aspects of the Drugs and Cosmetics Act and Rules and sends the recommendations to the Ministry of Health and Family Welfare, Government of India for its approval.

10. DTAB ordinarily meets twice a year. For certain urgent matters, DTAB can be summoned with one week's notice. Some times very urgent matters can be, on priority basis, decided by the Ministry of Health and Family Welfare, Government of India. However, such decisions of the government are required to be ratified by DTAB within 6 months. The board advises the central government and the state government on the technical matters arising out of the administration of the Act. It advices the central government in framing and modifying the rules under the act related to import, manufacture, sale and distribution of drugs

11. It is the Advisory Body nominated by the Central Government for advising the Central and State Governments, as well as, the DTAB on the matters pertaining to the uniform implementation of the provisions of DCA and Rules. The composition of DCC is represented by two representatives nominated by the Central Government and one representative each of the State Government and Union Territory. Usually, the Director of Drugs Control Administration or Drug Controller of State is nominated by the State Government or Union Territory on this Council. Drugs Consultative Committee (DCC)

12. Central Drugs Laboratory (CDL) The Central- Drugs laboratory is headed by the Director with its headquarters at Kolkata. It is the Statutory Analytical Laboratory for drugs and cosmetics under DCA whose decision with regards to analysis is final in the court of law. The CDL is charged with the following responsibilities. 1. It takes up the analysis of samples of drugs and cosmetics sent by custom collectors and different courts

13. 2. As directed by the Central Government, it advises the Central Government and the State Governments and Union Territories on the matters pertaining to the analysis of drugs and cosmetics and also takes up analytical work of specific nature for samples sent by Central Government and State Governments. 3. It may take up the samples for analysis on payment of necessary fee for private parties, consumer organization, etc. 4. It is engaged in the research for the development of newer techniques of analysis of drugs and cosmetics.

14. For the analysis of following items, the Director of concerned laboratory as indicated, has all the powers of the Director of CDL under the provisions of the Act. Director, Central Research Institute (CRI), Kasauli , H.P: for biological preparations such as vaccines, sera, toxins, toxoids, etc., and also bacteriophages, surgical sutures and ligatures Director, Indian Veterinary Research Institute (IVRI), Izzat Nagar, U.P: for all biological products and other veterinary products meant for animals.

15. 3. Director, Central Indian Pharmacopoeia Laboratory (CIPL) Ghaziabad, U.P: for all homoeopathic medicines and condoms. 4. Director, National Institute of Communicable Diseases:- Oral Polio Vaccine The sample for analysis is required to be sent in sealed cover by registered post addressed to Director of the concerned laboratory. Along with this, a memorandum filled in by the person sending the sample for analysis in accordance with the procedure laid down should be accompanied separately in the same registered post.

16. Another copy of this memorandum is required to be sent separately with the impression of the seal by registered post to the Director. The registered post of sample and memorandum is received by the officer deputed on behalf of Director or Director himself. The impression of the seal in both the cases is compared and its genuinity is confirmed and only then, the seal is opened.

17. The sample is required to be kept under the custody of the Director or the officer identified by him until the analysis is over and thereafter, for a period of one year. On completion of the analysis, the protocol followed for analysis, analytical results and other relevant information are sent by registered post to the concerned party. Depending upon the urgency of the matter, priority for analysis is fixed. The decision given by CDL regarding analysis is final and not challengeable in the court of law.