Mandaviya asks MSME pharma firms to move towards good manufacturing practices through self regulation

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NEW DELHI, July 11: Union Minister Mansukh Mandaviya has asked the pharmaceutical firms in the MSME segment to move towards good manufacturing practices through self regulation, the Chemicals and Fertilisers Ministry said in a statement on Tuesday.

In a meeting with representatives of industry body IDMA, the minister stated that Schedule M will soon be made compulsory for MSME drug companies.

As per India’s Drugs and Cosmetics Act 1940, Schedule M refers to the good manufacturing practices that the manufacturing plans must follow.

“It is important for MSME pharma companies to be alert to quality of drugs and expeditiously move towards Good Manufacturing Processes (GMP) through self regulation,” Mandaviya said.

The Union minister stated that the country’s position in the global drug industry is due to the focus on quality production.

“We must undertake all possible steps to ensure that we strengthen this position in terms of value and quality. Hence, the role of self regulation becomes critical,” he stated.

Basis assurances given by the industry representatives, Mandaviya noted that Schedule M shall be made compulsory for the MSME pharma sector in a phased manner.

“This will help in quality assurance and also reduce compliance burden,” he said.

Mandaviya said he has directed the Drugs Controller General of India (DCGI) to take stringent action against all pharmaceutical manufacturing companies that make spurious drugs.

“There shall be no compromise with the quality of drugs manufactured in India,” he stated.

Elaborating that the government has zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines, he stated that special squads have been formed to inspect drugs making companies and stringent actions have been taken.

Mandaviya noted that in order to ensure the highest quality of pharma products, the regulatory authorities have started risk-based inspection and audit of plants. He stated that 137 firms were inspected, and action has been taken against 105 firms.

Production has been stopped at 31 firms and cancellation and suspension of product/section licences have been issued against 50 firms, he added.

In addition, show cause notices have been issued to 73 firms, and warning letters have been issued against 21 firms, the minister stated. (PTI)