Maha FDA Issues Show Cause Notices To 95 Drug Units For Failing To Comply With Schedule M

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Mumbai : In a bid to ensure that safe and quality drugs are available to people in the state, the Maharashtra Food And Drug Administration (FDA) has issued show cause notices to 95 pharmaceutical companies for non-compliance of good manufacturing practices as prescribed under Schedule M of the Drugs and Cosmetics Rules.

The show cause notices have been issued to the drug manufacturers following an inspection of 655 manufacturing units in all divisions of the state from January, 2022 to March, 2022. Of them, 366 drug units in Konkan Division have been inspected followed by Greater Mumbai 52, Pune Division 104, Nashik Division 43, Aurangabad Division 47, Nagpur Division 22, and Amravati Division 21.
Besides this, 16 manufacturing units have been issued stop production orders for serious violations till further orders and 17 manufacturers have been issued notice for submission of compliance report as an outcome of this inspection campaign.

“We have taken stern action against drug manufacturers failing to comply with the good manufacturing practices as prescribed under Schedule M of the Drugs and Cosmetics Rules,” said FDA commissioner Parimal Singh.

To ensure the good manufacturing practices in pharmaceuticals, the FDA, Maharashtra will continue to conduct inspection of drug manufacturers in the state so that the safe, efficacious and quality medicines are available to the general public, said Singh.

In order to ensure that all the medicines manufactured in the state are of good quality and safe, all the manufacturers have to comply with the provisions of Schedule M (Good Manufacturing Practices) of the Drugs and Cosmetics Act, 1940 and Rules thereunder, he added.

The FDA commissioner has issued instructions to all the divisional joint commissioners (drugs) and licensing authorities to provide training to the pharmaceutical manufacturer by organizing a webinar.

The manufacturing units of allopathic medicines in the state are inspected by the drug inspectors of the administration to ensure that the medicines are manufactured by adopting good manufacturing practices as laid down under Schedule M of the D&C Rules.

FDA enforces the Drugs and Cosmetics Act, 1940 and Rules, 1945 which regulates the production and sale of medicines and cosmetics in the state. The pharmaceutical manufacturers are required to produce quality medicines in accordance with the good manufacturing practices as prescribed under Schedule M of the Drugs and Cosmetics Rules.

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