DIs empowered for inspection for grant of drug sale licenses: Maha FDA

Before the November 2019 circular, inspections of drug retail premises were usually carried out by DIs

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Pharmacy Medical Store
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Last Updated on October 9, 2020 by The Health Master

The Maharashtra Food and Drug Administration (FDA) has issued a circular empowering drug inspectors (DIs) to inspect new drug retail premises for issuance of new drug licenses as per the Drugs and Cosmetics (D&C) Act. This job was earlier delegated to assistant drug commissioners (ADCs).

Maharashtra FDA had through a circular in November 2019 directed ADCs in the state to conduct inspections of retail trade premises for issuance of new drug retail and wholesale licenses to help drug inspectors to focus on drug sampling of existing license holders in a timely manner.

This in turn will lead to better compliance and help in improving and maintaining better quality controls of drugs for patient safety, according to Maharashtra FDA.

Also read: All DCOs notified as medical devices officers: AP

Before the November 2019 circular, inspections of drug retail premises were usually carried out by DIs. This according to a senior FDA official is done to utilise the experience of drug inspectors for inspecting premises of existing retail and wholesale licensees for better compliance.

New applicants are supposed to fill Form 20 and 21, Form 20 B and 21 B for getting retail and wholesale license respectively.

D&C Rules stipulates provisions to sell, stock or exhibitor offer for sale, or distribute drugs by retail other than those specified in Schedules C, C(1) and X as per provisions of the D&C Act,1940 and the Rules there under.  


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