Indian pharmaceutical GMP guidelines are given in Drugs & Cosmetics Act 1940. Rules are given for pharmaceuticals and schedules are there to comply those rules. MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) updates this time to time. Pharmaceutical industries in India those are manufacturing the drug products for domestic market have to follow the Drugs & Cosmetics Act. It contains 168 rules from 1 to 168 and 25 Schedules from Schedule A to Schedule Y . Different type of forms are also given for different type of approvals from drug authorities. Following are the schedules: Schedule A: Forms and applications Schedule B : Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories Schedule C : Biological and Special Products Schedule C(1): Other Special Products Schedule D: Class of Drugs: Extent and conditions of exemption Schedule D(I):...
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