Drug Regulatory Systems in India

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1. Drug Regulatory Systems in India By, CHANDRA MOHAN

2. Introduction Organizational Structure Drug Approval Process in India Differences between US, EU and India D&C Act, 1940 – D&C Rules, 1945 Types of licenses

3. Introduction In India drugs are regulated both at central and state level. At the central level CDSCO (Central Drugs Standard Control Organization) under the ministry of Health and Family Welfare is responsible for approving new drugs, clinical trials and licensing of drugs. At the state level state drug regulatory authorities issues licences to manufacture approved drugs to monitor the quality of the drugs along with CDSCO. In India the regulation of drug, medical devices, and biological and r-DNA products is distributed within various ministries.

4. Organizational Structure The Central Drug Standard Control Organization (CDSCO) is the key authority for new drug approvals in India , which is headed by the Drug Controller General of India (DCGI), and CDSCO is responsible for drug approval , overseeing clinical trials, good manufacturing practice (GMP) monitoring, and other related functions as specified by the central government. The CDSCO is a subordinate office of the Director General of Health Services (DGHS) in the Ministry of Health and Family Welfare (MHFW).

5. Main bodie s Central Drug Standard Control Organization (CDSCO) Ministry of Health & Family Welfare (MHFW) Indian Council of Medical Research (ICMR) Indian Pharmaceutical Association (IPA) Drug Technical Advisory Board (DTAB) Central Drug Testing Laboratory (CDTL) Indian Pharmacopoeia Commission (IPC) National Pharmaceutical Pricing Authority (NPPA)

6. Drug approval process in INDIA Form 44. Treasury Challan of INR 15,000 if all the active ingredients are approved in India for more than one year, or INR 50,000 in case any of the active ingredients is approved for less than one year. Source of bulk drugs /raw materials: For those ingredients which are approved and considered new drugs - If the applicant has a manufacturing license for bulk drugs, a copy of the same is needs to be submitted. Otherwise, provide the consent letter from the approved source regarding supply of material.

7. D&C Act, 1940–D&C Rules, 1945 Changes to regulate the import, manufacture, sale or distribution Drugs & Cosmetics for assuring their Quality, Safety and Efficacy Regulate through a system of Licensing/Issuing permits The Act has 6 Chapters Rules has 19 parts

8. Scheme of the D&C Act THE ACT - SIX CHAPTERS Chapter I - Preliminaries & Definitions Chapter II - CDL, DCC, DTAB Chapter III - Import of Drugs & cosmetics Chapter IV - Manufacture and Sale of Drugs & Cosmetics Chapter IVA - Ayurvedic Drugs Chapter V - Miscellaneous

9. Schedules SCHEDULE A – Forms SCHEDULE B – Fee for Test or Analysis SCHEDULE C – Biological & Special Products SCHEDULE C1 – Other Special Products SCHEDULE D – Exemptions u. c. III SCHEDULE D(1) – Information – Product Registration for import

10. Schedules SCHEDULE D(II) – Details for Import SCHEDULE F(I) – Bacterial Vaccines, Sera SCHEDULE FF – Standards Ophthalmic preparations SCHEDULE G – Drugs to be used under the supervision of RMPs SCHEDULE H – Prescription Drugs

11. Schedules SCHEDULE J – Prohibition on advertisements on drugs SCHEDULE M – Good Mfg Practices SCHEDULE N – Pharmacy- requirements SCHEDULE P – Life Period of drugs SCHEDULE P 1 – Pack size of drugs SCHEDULE U – Records – Drugs SCHEDULE Y – Requirements and Guide lines for permission to import and/or manufacture of New Drugs for sale or undertake Clinical Trials

12. Types of Licenses Manufacture for sale Manufacture for test, examination or analysis Sale of Drugs – Whole sale, Retail, Restricted Import of Drugs

13. Forms for Licenses Manufacturing Unit (Other than those specified in C, C1 & X): Application – Form 24 License – Form 25 Loan License (Other than those specified in C, C1 & X): Application – Form 24 A License – Form 25 A Repacking ( Other than those specified in C, C1 & X): Application – Form 24 B License – Form 25 B

14. Forms for Licenses Manufacturing Unit (Schedule X): Application – Form 24 F License – Form 25 F Manufacturing Unit (Schedule C & C1): Application – Form 27 License – Form 28 Loan License (Schedule C & C1): Application – Form 27 A License – Form 28 A

15. Import Licenses

16. Import Licenses

17. THANK YOU! Questions ?