A call to manufacturers to submit Stability data of non-patent and proprietary medicines from DCGI

The Drugs Controller General of India (DCGI) asks manufacturers to submit stability data, as this is important to ensure the quality, safety, and efficacy of the drugs throughout its shelf life. Drug manufacturers will get permission to manufacture drugs based on their stability data reports.

All state/UT drugs controllers have directed pharma companies to submit stability data to ensure drugs are meeting quality standards and are effective until their expiry date.The DCGI has also asked to submit self-assessment report of their units along with self-certification. Self-declaration should state that they are complying with GMP/GLP requirement as per Drugs and Cosmetic Rules, to the State Licensing Authorities and CDSCO by 30.08.2017.

To regulate import, manufacture, and distribution of the drugs, there is an act passed in 1940, called the Drugs & Cosmetics Act and in 1945, one more act

made under the Act prescribe statutory requirements for a grant of a license to manufacture for sale and distribution of drugs to ensure safety, efficacy, and quality of drugs manufactured and sold in the country called The Drugs & Cosmetics Rules.

The manufacturers should ensure that they are following best practices and guidelines to the licensing authority, evidence and data justifying that the medicines are stable under the condition of storage recommended getting licenses for non-patent and proprietary medicines.

A detailed checklist prepared by the DCGI office earlier to check all manufacturing facilities comply with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) as specified under Schedule M and Schedule L-1 of the Drugs and Cosmetics Act and Rules there under. This list will guarantee that each manufacturer carries out self-assessment to GMP/GLP compliance.


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