With nearly 80 per cent manufacturers having responded to Maharashtra Food and Drug Administration (FDA)'s self-audit exercise, the state regulator is going to undertake a massive exercise of verifying the good manufacturing practices (GMP) compliance levels based on which action will be taken on the concerned manufacturers.

A task force of seven joint commissioners was formed to review the self-audit check-list shared with manufacturers few months ago.  Schedule M units in the state were also directed to do self-auditing of the manufacturing sites based on issuance of check-list by the state regulator.

The responses on the checklist for self audit by the concerned manufacturers are meant to assess adherence to the licensing conditions by the concerned manufacturer as envisaged in the Drugs and Cosmetics Act.  

Informed Maharashtra FDA Commissioner Pallavi Darade, “I have directed all the Joint Commissioners to seriously examine check-list of self audits from around 800 manufacturers across the state to verify compliance and take necessary action.”

The checklist is meant to help Central Drugs Standard Control Organisation (CDSCO) and state drug regulators to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant. CDSCO checklist and evaluation is also aimed at streamlining uniform inspection procedures across the country related to GMP.

Primarily done to maintain compliance levels, the state regulator did a similar kind of exercise with 70,000 drug retailers in the state.

The CDSCO has also been conducting risk based inspections across the country to verify GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945. It concluded 185 risk based inspections in 8 phases last year.

These risk based inspections are based on a checklist issued for the state drug regulators to ensure that there is uniformity of inspections across all the Schedule M units in the country.