The Maharashtra Food and Drug Administration (FDA) is at present looking at examining of self-reviews from around 800 manufacturers over the state to verify compliance with good manufacturing practices (GMP). A panel of seven joint commissioners has been formed to review the checklist and take subsequent action in view of the same.
Schedule M units in the state were prior directed to do self-reviewing of the manufacturing sites based on issuance of check-list by the state regulator before an inspection.
Maharashtra FDA Commissioner Pallavi Darade informed, “This is primarily done to maintain compliance levels achieved so far over the past several years for the very reason that Maharashtra has been among the most regulated states. Central Drugs Standard Control Organization (CDSCO) has appreciated our efforts towards conducting similar kind of activity with 70,000 drug retailers in the state”.
Joint inspections will take after post the verification activity, she included. The checklist and tool are intended to help CDSCO and state drug regulators to understand and collaborate together which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been examined and are found to be compliant.
The responses on the checklist for self-review by the concerned manufacturers is intended to assess adherence to the licensing conditions by the concerned manufacturers as envisaged in the Drugs and Cosmetics Act.
The CDSCO has also been conducting risk-based inspections the country over to verify GMP compliance according to the provisions stated 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 on a checklist issued by the state drug regulators to ensure that there is uniformity of inspections over all the Schedule M units in the country. CDSCO checklist and evaluation is also gone for streamlining uniform review methodology the country over related to GMP.