With about 80 percent manufacturers having responded to Maharashtra Food and Drug Administration (FDA’s) self-audit exercise, the state controller will attempt a massive exercise of verifying the good manufacturing practices (GMP) compliance levels based on which action will be taken on the concerned manufacturers.
A team of seven joint commissioners was formed to review the self-audit list shared with manufacturers a few months back. 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 controller.
The responses on the checklist for self-audit by the concerned manufacturer are intended to evaluate 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 guided all the Joint Commissioners to seriously examine check-list of self-audits from around 800 manufacturers over the state to verify compliance and take essential action.”
The checklist is intended to help Central Drugs Standard Control Organization (CDSCO) and state drug regulators to understand which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are observed to be compliant.
CDSCO checklist and evaluation is also aimed at streamlining uniform inspection procedures the country over related to GMP. Essentially done to maintain compliance levels, the state regulator completed a similar kind of exercise with 70,000 drug retailers in the state.
The CDSCO has also been directing risk-based reviews the country over to verify GMP compliance according to the provisions expressed under Schedule M of Drugs and Cosmetics Rules, 1945. It concluded 185 risk-based inspections in 8 phases a year ago.
These risk-based inspections are based with respect to a checklist issued for the drug regulators to ensure that there is the consistency of inspections over all the Schedule M units in the country.