Mumbai: Maharashtra Food and Drug Administration (FDA) has directed Assistant Drug Commissioners (ADCs) in the state to conduct inspections of trade premises for issuance of new drug retail and wholesale licenses.
These inspections were earlier carried out by the drug inspectors wherein new applicants are supposed to fill Form 20 and 21, Form 20 B and 21 B for retail and wholesale license respectively.
This according to a senior FDA official is done to utilise the manpower of drug inspectors for inspecting premises of existing retail and wholesale licensees for better compliance.
D&C Rules stipulates provisions to sell, stock or exhibit or 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 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 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 controlling authority and to make such enquiries and inspections as may be necessary to detect the violations.
This is a historic decision taken by the state FDA whereby drug inspectors will have ample time to concentrate on drug sampling of existing license holders. This in turn will lead to better compliance and help in improving and maintaining better quality controls of drugs for patient safety.