Show cause notices to 95 drug units.

Thursday April 14, 2022 at 12:44 pm

With its objective to ensure that safe and quality drugs are available to people in Maharashtra, the state Food And Drug Administration (FDA) of Maharashtra has issued a show-cause notice to 95 pharma companies seeking reasons for their non-compliance with good manufacturing practices, which are prescribed under Schedule M of the Drugs and Cosmetics Rules.

These show-cause notices have been issued to these drug manufacturers after an inspection of some 655 manufacturing units in all the various divisions of the state of Maharashtra in the first three months of this calendar year, from January 2022 to March 2022. As many as 366 drug units in Konkan Division have been inspected, followed by 52 in Greater Mumbai, 104 in the Pune Division, 43 in the Nashik Division, 67 in the Aurangabad, 22 in the Nagpur Division, and 21 in the Amravati Division.

Besides this, 16 manufacturing units have been issued stop production orders for serious violations till further orders, and 17 manufacturers have been given 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,” informed Food And Drug Administration (FDA) commissioner Parimal Singh.

To ensure the good manufacturing practices in pharmaceuticals, the Food And Drug Administration (FDA) of Maharashtra state will continue to conduct the inspections of various drug manufacturers across the state so that the safe, effective, and quality drugs are available the general public, Parimal Singh claimed.

In order to ensure that all the medicines manufactured in the state of Maharashtra are of good quality and safe, all the manufacturers are required to comply with the provisions of Schedule M (Good Manufacturing Practices) of the Government of India’s Drugs and Cosmetics Act, 1940 and Rules thereunder, he asserted

The Food And Drug Administration (FDA) commissioner has already issued instructions to all the joint divisional commissioners (drugs) and various licensing authorities to provide adequate training to the pharmaceutical manufacturers by organizing a webinar.

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

Food And Drug Administration (FDA) enforces the union government’s Drugs and Cosmetics Act, 1940 and Rules, 1945. The law regulates the state’s production and sale of all medicines and cosmetics. The pharms manufacturers of the region are required to produce only quality medicines in accordance with the highest good manufacturing practices and according to the rules prescribed under Schedule M of the Drugs and Cosmetics Rules.

Unfortunately, a number of discrepancies are found now and then where the major pharma companies of the state fail to comply with these rules. The show-cause notice issued by the Food And Drug Administration (FDA) is the next corrective measure in this regard. One must note that not only the sub-standard drugs may be inefficient, but they are also likely to do a lot of harm. The various governments all over the country and the world have increased their focus on the pharma sector after the covid-19 pandemic shook the world. The union government of India, too, is taking a number of concrete steps to encourage the growth of Indian pharma, which had the incredible achievement of making India the only country that was the birthplace of two COVID-19 vaccines industry has grown in leaps and bounds ever since.