. The Maharashtra FDA Issues Suspension of Licenses Basis Non-Compliance

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The Maharashtra FDA Issues Suspension of Licenses Basis Non-Compliance

Over the past six months, Maharashtra Food and Drug Administration (FDA) has cancelled 278 retail licenses and suspended 1,439 licenses across the state for non-compliance to Drugs and Cosmetics Act. This action is an outcome of state drug regulator’s routine inspections on drug retail shops and 2908 wholesale inspections.

In an interview with Maharshtra FDA Commissioner Dr.PallaviDarade said that FDA during its inspections detected violations to Good Pharmaceutical Practices (GPP) like dispensing Schedule H drugs without prescription, absence of proper purchase and  sale bills and non-availability of pharmacists in the drug retail stores across the state.

Maharashtra FDA has served the regulatory and compliance needs of close to 10,000 medical stores in Maharashtra. A check list was issued to all the medical stores and wholesalers to help them to be self -compliant before a surprise raid or routine inspection by the state regulator prior to conducting workshops.

In an attempt to be more vigilant, Maha FDA lodged 6 FIRs related to non-compliance like absence of pharmacist and dispensing drugs without bills.

Around 36 manufacturing unit’s licenses are cancelled and another 90 suspensions were issued after serving 136 show cause notices (SCN) for non-compliance of D&C Rules. The state regulator had conducted 837 inspections in the past 6 months for the period from April 2017 to October 2017.

Central Drugs Standard Control Organisation (CDSCO) and Maharashtra FDA are also scheduled to conduct joint inspections of Schedule M units for compliance to good manufacturing practices (GMP).  CDSCO and State FDA are aimed at streamlining the inspection process to implement robust GMP practices across industry.

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