Date: 09-Oct-2020

Maharashtra FDA Issues Circular Empowering DIs To Inspect Drug Retail Premises

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.

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.  

As per section 51 of D&C Rules 1945, it shall be duty of the drug inspector authorized to inspect premises licensed for the sale of drugs, to inspect not less than once a year all establishments licensed for the sale of drugs within the area assigned to him, to satisfy himself that the conditions of the licenses are being observed, to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules there under.

The duties of the drug inspector is also to investigate any complaint in writing which may be made to him, to institute prosecutions in respect of breaches of the D&C Act and Rules there under, to maintain a record of all inspections made and action taken by him in the performance of his duties including the taking of samples and the seizure of stocks.

Subsequent to this, he/she will also submit copies of such record to the state drug controlling authority and to make such enquiries and inspections as may be necessary to detect the violations.