Act for Ayurvedic medicine-1940
Initially, it is the form of Drug Act 1940, whose purpose was to import-export, manufacture,sale and distribution.The main amendments related to Ayurveda took place in 1964. Ayurvedic manufacturing industries come under this Act. Under this, the provision of new licenses,Renewal,Definitions of guidelines for GMP ect. are made.
Schedule-T: Good manufacturing practices for Ayurvedic siddha & unani medicine.
Schedule-E: List of poisonous substances.
- Drugs of vegetable origin.
- Snake poison.
- Poison of mineral origin.
- Section 33C– Ayurvedic & Unani Drugs technical Advisory Board.
- Section 33D– Ayurvedic, Siddha & unani Drugs Consultative committee.
- Section 33E– Defines misbranded ASU Drugs.
- Section 33EE– Adultrated Drugs.
- Section 33EEA– Defines spurious ASU Drugs.
- Section 33EEB– Regulates to manufacture & sale for ASU Drugs.
- Section 33EEC– Prohibits misbranded, Adultrated & sale for ASU Drugs.
- Section 33EED– Provides power to centeral government to prohibit manufacture etc. of ASU drugs in public interest.
- Section33-1 – Provides penalty for manufacture, sale etc.of ASU drugs in contravention of the chapter IVA of the Drugs & cosmetics rules.
- Section 33N– Provides power to control Government to amend the rules in the Drugs & Cosmetics.
PART XIV the Drugs & Cosmetic Rule 1945
- Rule- 153 – Provides power to state gov. to appoint state licensing Authorities of ASU medicines by notification in official gazette.
- Rule-153A – Prescribe to apply license for manufacture of ASU medicines in from 24D to the state licensing Authority.
- Rule-155 – Prescribe to Award the certificate of GMP for ASU manufacturing unit.
- Rule-160-A – Provide for Approval of private drugs testing laboratories for ASU medicines.
- Rule-161 – Prescrives provisions for labeling, packing & limit of alcohol of ASU medicines.
- Rule-161-A – Provides provisins for exemption in labeling & Packing of export of ASU medicines.
Drugs & Cosmetics Act 1945 part XVII(17)- (161-B)
Expiry date for Ayurvedic medicines or period of self life.
By: Dr. Ranjeet Singh