On 03-02-2015, the Central Government published the draft Drugs and Cosmetics (Second Amendment) Rules, 2015 and sought for objections and suggestions from any person with respect to the said draft rules within 45 days from the date of publication of the draft. The objective of the draft Rules is to further amend the Drugs and Cosmetics Rules, 1945 in order to assure that the licensed manufactured drugs are stable for proposed shelf life under the condition of storage. The draft Rules proposes following amendments in the Drugs and Cosmetics Rules, 1945:
- Insertion of sub-Rule (6A) after sub-Rule 6 in Rule 71, insertion of sub-Rule (2) after Rule 71-B which shall be numbered as sub-Rule (1), insertion of sub-Rule (7A) after sub-Rule 7 in Rule 76, insertion of sub-Rule (2) after Rule 76A which shall be numbered as sub-Rule (1), and all of which provides that “the applicant shall, while applying for licence to manufacture drugs, furnish to the Licensing Authority evidence and data justifying that the drugs are stable for proposed shelf life under the condition of storage recommended and the data shall be generated as per Appendix IX of Schedule Y”.
- Substitution of following entry “Substances not intended for medicinal use excluding those intended to be used as drugs after further purification or rendering them sterile” in place of “Substances not intended for medicinal use”, in Schedule D, against item number 1, under the column “Class of drugs”.
-Ministry of Health and Family Welfare