New Delhi: Maharashtra FDA had carried out 2,540 inspections on 2,493 manufacturing units across the state since April 2016 till date and on the basis of the results, Maha FDA has canceled 58 manufacturing licenses and suspended 145 licenses for disobeying the provisions of the Schedule M and Schedule T of the Drugs and Cosmetics Act, 1940 and Rules there under.
According to a recent report in Pharmabiz, this comes at a time when the manufacturing units are upgrading to the standards followed in regulated markets for which the state regulator has directed them to do self-assessment of their compliance levels. A risk based inspection comprising officials from the Central Drugs Standard Control Organisation (CDSCO) and State FDA will also follow to assess the preparedness of the units towards good manufacturing practices (GMPs) and help them shield in the event of a regulatory scrutiny from other regulated markets.
GMPs include factors such as sanitation and hygiene, qualification and validation, self-inspection, quality audits, suppliers’ audits, prevention of cross-contamination and bacterial contamination during production, training employees and personal hygiene as per the WHO website.
Union health ministry has directed manufacturers for self-assessment of drug regulators as part of CDSCO’s new draft checklist and evaluation tool released recently aiming at streamlining uniform inspection procedures across the country related to GMP.
CDSCO officials and drug inspectors of the states will carry out the inspection jointly using checklist and tool which will help them to understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant.
CDSCO is also planning to bring about uniformity in inspections of Schedule M units across the country as a part of its program to upgrade Schedule M units to WHO-GMP level.