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Maharashtra FDA has canceled 58 manufacturing licenses and suspended 145 licenses based on 2,540 inspections carried out on 2,493 manufacturing units across the state since April 2016 till date. The cancellations and suspensions have been done for contravening the provisions of the Schedule M and Schedule T of the Drugs and Cosmetics Act, 1940 and Rules thereunder.
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.
Ongoing audits by drug regulators of regulated markets along with their Indian counterparts has also led companies to adopt and upgrade their units in line with current good manufacturing practices (cGMP).
This will be a big boost to several Indian drug makers which had come under the scanner of the global drug regulatory authorities in the recent years over a range of issues like data integrity, including production quality, sanitation standards and alleged data manipulation.
As per the WHO website, 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.
Aimed at streamlining uniform inspection procedures across the country related to GMP, Union health ministry has also directed manufacturers for self assessment of drug regulators as part of CDSCO's new draft checklist and evaluation tool released recently.
The checklist and tool will help CDSCO and state drug regulators understand and collaborate which pharmaceutical and active pharmaceutical ingredient (API) manufacturing sites have been inspected and are found to be compliant. The inspections are planned to be carried out jointly by the CDSCO officials and drug inspectors of the states concerned.
CDSCO is also planning to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP level. The current upgradation of WHO-GMP norms is being evolved around the learning from global regulatory counterparts on cGMP to help manufacturers adopt global GMP practices.
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