4 DTAB, DCC, CDL.pptx T Y Pharm.D Subject Pharmaceutical Jurisprudence

ADMINISTRATION OF THE ACT AND RULES(A)

Advisory
1 Drugs Technical Advisory Board,
2. Drugs Consultative Committee
Analytical
1. Central drugs Laboratory
2. Government analysts
Controlling authorities
3. Drugs Inspectors

1. 1. Drugs Technical Advisory Board, 2. Drugs Consultative Committee Analytical 1. Central drugs Laboratory 2. Government analysts Provisions Relating To Indigenous Indigenous Systems : T Y Pharm.D Subject Pharmaceutical Jurisprudence

2. ADMINISTRATION OF THE ACT AND RULES(A) Advisory 1 Drugs Technical Advisory Board, 2. Drugs Consultative Committee Analytical 1. Central drugs Laboratory 2. Government analysts Controlling authorities 3. Drugs Inspectors

3. DRUGS TECHNICAL ADVISORY BOARD In pursuance of section 5 of the Drugs and Cosmetics Act, 1940, the Central Government appoint the Drugs Technical Advisory Board consisting of the following members, Ex Officio members: 1. The Director General of Health Services, New Delhi (Chairperson) 2. The Drugs Controller, India, New Delhi 3. The Director, Central Drugs Laboratory, Kolkata 4. The Director, Central Research Institute, Kasauli 5. The Director, Indian Veterinary Research Institute, , Bareilly, U.P.

4. 6. The President, Medical Council of India 7. The President, Pharmacy Council of India 8. The Director, Central Drug Research Institute, Lucknow Nominated and elected members 9. Two persons to be nominated by the Central Government from among persons who are in charge of drugs control in the States; 10. One person, to be elected by the Executive Committee of the Pharmacy Council of India, from among teachers in pharmacy or pharmaceutical chemistry or pharmacognosy on the staff of an Indian university or a college affiliated thereto;

5. 11. One person, to be elected by the Executive Committee of the Medical Council of India, from among teachers in medicine or therapeutics on the staff of an Indian university or a college affiliated there to; 12. One person to be nominated by the Central Government from the pharmaceutical industry; 13. One pharmacologist to be elected by the Governing Body of the Indian Council of Medical Research 14. One person to be elected by the Central Council of the Indian Medical Association: 15. One person to be elected by the Council of the Indian Pharmaceutical Association; 16. Two persons holding the appointment of Government Analyst under this Act, to be nominated by the Central Government. The nominated and elected members of the Board shall hold office for three years, but shall be eligible for re- nomination and re-election

6. The Drugs Technical Advisory Board (DTAB) in India is a key advisory body under the Ministry of Health and Family Welfare. Its main functions include: Policy Advisory : DTAB advises the government on the formulation and amendment of drug-related policies and regulations. Technical Recommendations : It provides recommendations on the approval of new drugs, including guidelines for clinical trials and standards for drug efficacy and safety. Quality Standards : The board develops and revises standards for the manufacture and quality control of drugs and pharmaceuticals. Regulatory Framework : DTAB assists in drafting regulations under the Drugs and Cosmetics Act, ensuring compliance with modern scientific standards.

7. Public Health Guidance : It offers advice on issues related to public health, including drug usage and safety concerns. Monitoring and Evaluation : The board monitors and reviews the implementation of drug policies and regulations to ensure effectiveness. Expert Consultations : DTAB facilitates discussions among experts and stakeholders in the pharmaceutical industry to address emerging issues. Through these functions, DTAB plays a vital role in ensuring that the drug regulatory framework in India is robust, evidence-based, and responsive to public health needs.

8. THE DRUGS CONSULTATIVE COMMITTEE (1) The Central Government may constitute an advisory committee to be called -the Drugs Consultative Committee to advise the Central Government, the State Governments and the Drugs Technical Advisory Board on any other matter tending to secure uniformity throughout India in the administration of this Act. (2) The Drugs Consultative Committee shall consist of

9. a. Two representatives of the Central Government to be nominated by that Government and   b. One representative of each State Government to be nominated by the State Government concerned.   (3) The Drugs Consultative Committee shall meet when required to do so by the Central Government and shall have power to regulate its own procedure  

10. The Drugs Consultative Committee (DCC) in India serves several important functions related to drug regulation and safety. Here are the key roles it plays: Policy Advisory : The DCC provides recommendations to the government on various aspects of drug regulation, including policies related to drug approval, safety, and efficacy. Standards and Guidelines : It helps in formulating and updating standards and guidelines for the manufacture, distribution, and sale of drugs to ensure quality control. Review and Discussion : The committee discusses issues related to drug regulation, such as the evaluation of new drugs, adverse drug reactions, and other safety concerns.

11. Coordination : It acts as a coordinating body between different stakeholders in the pharmaceutical industry, including manufacturers, regulatory authorities, and healthcare professionals. Research and Development : The DCC encourages and evaluates research initiatives aimed at improving drug safety and efficacy. Capacity Building : It promotes training and capacity-building initiatives for regulatory personnel to enhance their knowledge and skills in drug regulation. Overall, the DCC plays a critical role in ensuring that drugs available in India are safe, effective, and of high quality.

12. The Central Drugs Laboratory   Provides for the establishment of a Central Drugs Laboratory under the control of a director appointed by Central Government. The Laboratory established in Calcutta has been entrusted with the following functions 19 1) to analyze or test samples of drugs or cosmetics sent to it by the cosmetics collectors or courts. 2) to carry out such other duties entrusted to it by the Central Government or with its permission, by State Governments, after consultation with DTAB. ➤ The Central Research Institute, Kasauli carries out functions in respect of sera, solutions of serum, proteins for injections, vaccines, toxins, antigens, antitoxins, sterilized surgical ligatures and sutures and Bacteriophages .

13. ➤ Vetenary Research Institute, Izantnagar and Mukteshwar carries out functions in respect of antisera , vaccines, toxoids & diagnostic antigens, all for Vetenary Use. ➤ Samples of condoms are sent to Central Pharmacopoeial Laboratory, Ghaziabad. Samples of oral poliomyelitis vaccines are sent to Pasteur Institute of India. ➤ Central Government has additional laboratories as reference centers on AIDS Functions in respect of all homeopathic medicines are carried out at Homeopathic Pharmacopoeial Laboratory, Ghaziabad.

14. GOVERNMENT ANALYSTS The Central Government or a State Government may, by notification in the Official Gazette, appoint such persons as it thinks fit, having the prescribed qualifications, to be Government Analysts for such areas as may be assigned to them by the Central Government or the State Government, as the case may be. No person who has any financial interest in the manufacture or sale of any drug shall be appointed to be a Government Analyst under this section. QUALIFICATIONS OF GOVERNMENT ANALYST Government Analyst under the Act shall be a person who 1. is a graduate in medicine or science or pharmacy or Pharmaceutical Chemistry of University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose and has had not less than five years' post-graduate experience in the testing of drugs in a laboratory under control of 

15. (1) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority, or has completed two years training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory, or 2. possesses a post-graduate degree in medicine or science or pharmacy or Pharmaceutical chemistry of University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such as

16. purpose or possesses the Associateship Diploma of the Institution of Chemists (India) obtained by passing the said examination with "Analysis of Drugs and Pharmaceuticals" as one of the subjects and has had after obtaining the said post-graduate degree or diploma not less than three years' experience in the testing of drugs in a laboratory under the ( i ) a Government Analyst appointed under the Act, ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority or has completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory.

17. PROVISIONS RELATING TO INDIGENOUS SYSTEMS: INDIGENOUS SYSTEMS: The term refers to traditional systems of medicine practiced in India, such as Ayurveda , These systems are considered integral to the healthcare practices in in India and are regulated under the Act. PROVISIONS APPLICABLE TO AYURVEDIC In India, the sales, import, labeling, and packaging of Ayurvedic medicines are governed by specific regulations to ensure quality and safety while respecting traditional practices: Sales and Import Regulatory Authority : The Ministry of AYUSH regulates Ayurvedic medicines through the Central Drugs Standard Control Organization (CDSCO) and the Department of AYUSH.

18. Licensing : Importers must obtain an Import License for Ayurvedic products, ensuring compliance with the Drugs and Cosmetics Act, 1940. Quality Standards : Ayurvedic products must meet stringent quality standards, often requiring a Certificate of Analysis to verify safety and efficacy. Labeling and Packaging Labeling Requirements : Labels must include the product name, ingredients, dosage, instructions, and precautions, in English and/or Hindi. Claims must be substantiated. Traditional Claims : Specific claims related to the efficacy of Ayurvedic treatments must comply with guidelines set by AYUSH. Packaging Standards : Packaging should be tamper-proof and ensure product integrity, with clear information to prevent misuse.

19. Provisions Relating to Indigenous Systems Protection of Traditional Knowledge : Regulations aim to protect traditional knowledge and prevent biopiracy , ensuring that indigenous communities benefit from their contributions. Clinical Trials : While some traditional claims may not require extensive clinical trials, establishing safety and efficacy is encouraged for broader acceptance. Ethical Sourcing : Sourcing of herbal ingredients must be sustainable and respectful of local biodiversity and community rights.

20. Conclusion Navigating the regulatory landscape for Ayurvedic medicines in India requires adherence to quality standards and a commitment to ethical practices, ensuring the protection of traditional knowledge while meeting consumer safety needs.