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India to mandate Schedule M for MSME Pharma Units: Health Minister Mandaviya

The health minister asked the pharma enterprises to move towards good manufacturing practices (GMP) as laid down in the Schedule M through self-regulation

• By Pooja Chaturvedi Sah
• New Delhi
• Jul 12, 2023

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The Indian Government will make ‘Schedule M of the Drugs and Cosmetics Act, 1940’ compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing in order to ensure the quality and to reduce the compliance burden in the pharma sector.

The decision was announced by Union Health Minister Mansukh Mandaviya while chairing a meeting with pharma companies from the MSME sector and industry representatives on Tuesday.

The Health Minister asked the pharma enterprises to move towards good manufacturing practices (GMP) as laid down in the Schedule M through self-regulation, and said that the adherence to Schedule M practices will be implemented in a phased manner.

Schedule M covers various practices related to shop floors, quality control system, quality check labs, production, cleaning of equipment and housekeeping, among others.

“It is important for MSME pharma companies to be alert to quality of drugs and expeditiously move towards Good Manufacturing Practices (GMP) through self-regulation. The need for self-regulation in the MSME pharma sector is important for India to maintain the status of ‘Pharmacy of the World," said Mandaviya. 

The Indian pharma industry and its reputation was marred by few incidents of deaths globally, allegedly due to consumption of drugs made in the country.

Stating that there shall be no compromise with quality of drugs manufactured in India, the Minister reiterated the government’s zero tolerance towards manufacturers not adhering to quality compliance and making spurious medicines. 

He said that he has directed the Drugs Controller General of India to take stringent against companies that make spurious drugs. 

“Special squads have been formed to inspect drugs making companies across the country,” said Mandaviya.

The Minister further said that in order to ensure the highest quality of pharma products, the regulatory authorities have started risk-based inspection and audit of manufacturing units. Over the last few months, around 137 firms were inspected and action has been taken against 105.

The Health Ministry also informed that the production has been stopped at 31 firms and cancellation & suspension of product/section licenses have been issued against 50 firms. 

“In addition, show cause notice has been issued to 73 firms, and warning letters have been issued against 21 firms", the ministry said in a statement.

“Our global position in the pharmaceutical sector is created through the quality of our products. We must undertake all possible steps to ensure that we strengthen this position in terms of value and quality,” said Mandaviya.