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DCGI demands stability data for Non-Patented and Proprietary Drugs

In order to maintain quality of drugs, the Drugs Controller General of India (DCGI) has directed all the drug manufacturers to submit the stability data of non-patent and proprietary medicines. At the time of submission of application for grant of permission to manufacture medicines, the manufacturer will now submit stability data of non-patent and proprietary medicines to ensure quality of products. The DCGI in a letter to all UT/State drug controllers, instructed to bring uniform jurisdiction to submit all stability data at the time for grant of license to manufacture non-patented and proprietary drugs.

The Drugs & Cosmetics Act, 1940, is an Act, to regulate import, manufacture, distribution and sale of drugs and cosmetics. The Drugs & Cosmetics Rules, 1945, made under the Act prescribe statuary requirements for grant of license to manufacture for sale and distribution of drugs to ensure safety, efficacy and quality of drugs manufactured and sold in the country. One of the conditions for grant of license to manufacture for sale and distribution of patent or proprietary medicines is that the applicant shall furnish to the licensing authority evidence and data justifying that the medicines are stable under the condition of storage recommended.

In another letter, DCGI has asked all drug manufacturers to submit the report of self -assessment of their units plus a self-certification stating that they are complying with GMP/GLP requirements as laid down by Drugs and Cosmetics Rules, to the state licensing authorities and CDSCO. All drug manufacturers and pharmaceutical associations were requested vide notice no. 7-5/2016/misc/041 dated 23.07.2015 to make self-assessment of their manufacturing units as part of their self-audit and mandatorily share their reports with State Licensing Authorities and CDSCO.

However, CDSCO is yet to receive self-inspection reports from manufacturers.



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