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Maha FDA soon to conduct risk-based inspections based on self audit exercise of Schedule M units

Shardul Nautiyal, Mumbai
Tuesday, April 17, 2018, 08:00 Hrs  [IST]

The Maharashtra Food and Drug Administration (FDA) will soon conduct risk-based inspections on Schedule M units based on the evaluation and assessment of check lists provided by the latter.

The risk-based inspections which will be done in a phased manner in the form of surprise raids is aimed at making manufacturers realise the importance of compliance and adhere to the best global good manufacturing practices.

Nearly 80 per cent manufacturers have responded to Maharashtra FDA self-audit exercise which started with issuance of check lists to all the manufacturers. Following which the state regulator is going to undertake a massive exercise of checking the good manufacturing practices (GMP) compliance levels.

According to a senior FDA official, “We may also suspend or cancel licenses taken of the concerned manufacturers based on the findings and if the rules are blatantly flouted with due consideration to safety and efficacy.”

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 directed to do self-auditing of the manufacturing sites based on check-lists.

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.  

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.


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