Health Minister Mansukh Mandaviya emphasises self-regulation for pharma MSMEs

Health and Family Welfare Minister Mansukh Mandaviya held a meeting with the representatives of pharmaceutical companies from the MSME (micro, small and medium enterprises) sector. During the session, he stressed the significance of self-regulation in drug manufacturing to uphold quality standards and urged pharma companies to adopt Good Manufacturing Processes (GMP).

“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. Hence, the role of self-regulation becomes critical,” he said.

During the meeting, he also announced that Schedule M will be made compulsory for the pharma MSMEs in a phased manner. Schedule M, a part of the Drugs and Cosmetics Act 1940, outlines the Good Manufacturing Practices that pharmaceutical manufacturing units in India should adhere to.

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

He instructed the Drugs Controller General of India (DCGI) to enforce strict measures against pharmaceutical manufacturers producing spurious drugs. He asserted that there shall be no compromise with the quality of drugs manufactured in India.

Highlighting the government's commitment to quality compliance, he revealed that special squads have been formed and stringent actions have been taken to eliminate the production and distribution of spurious medicines.

The regulatory authorities have started a risk-based inspection and audit of plants.

A total of 137 firms underwent inspections, resulting in actions taken against 105 of them. Production has ceased at 31 firms, while 50 firms received notices of product/section license cancellation or suspension. Furthermore, 73 firms have been issued show-cause notices, and 21 firms have received warning letters.