Mandaviya bats for self-regulation by small pharma firms, says won’t compromise on drug quality

Mansukh Mandaviya met the Indian Drug Manufacturers Association officials today.

The Union government on June 11 emphasised the importance of self-regulation in the medium, small, and micro enterprises (MSME) involved in drug manufacturing in India.

Union Minister of Chemicals and Fertilisers, Mansukh Mandaviya, met with representatives from MSME pharma companies to address the need for vigilance in maintaining the quality of drugs.

Mandaviya highlighted that the global reputation of India's pharmaceutical sector is built on the quality of its products. Therefore, it is crucial for MSME pharma companies to take all necessary measures to strengthen this position in terms of value and quality, making self-regulation a critical aspect.

As part of India's Drugs and Cosmetics Act 1940, the government plans to make Schedule M mandatory for pharmaceutical manufacturing units in the country. Schedule M outlines the Good Manufacturing Practices that these units must adhere to.

During the meeting, Mandaviya instructed the Drugs Controller General of India (DCGI) to take strict action against any pharmaceutical manufacturing companies involved in the production of counterfeit drugs. He emphasized that there should be no compromise when it comes to the quality of drugs manufactured in India.

To ensure the highest quality of pharmaceutical products, regulators have already begun conducting risk-based inspections and audits of manufacturing plants. Out of 137 firms inspected, action has been taken against 105 firms. Production has been halted in 31 firms, and cancellation and suspension of licenses have been issued against 50 firms. Show cause notices have been sent to 73 firms, and warning letters have been issued to 21 firms.

Mandaviya's remarks followed recent statements by Rajeev Raghuvanshi, the drug controller general of India, who mentioned that the Indian regulator is working towards rationalizing drug regulations in the country. The aim is to simplify the regulations for ease of doing business. Global consultants are being hired to explore opportunities for rationalization.

Raghuvanshi also identified the non-uniform implementation of the drugs and cosmetics act by different states as a challenge. He emphasized the need for improvement in the implementation of the law by the states.

He acknowledged the size of the Indian pharma industry as one of the major challenges, making it difficult to design regulations that are optimal for both MSMEs and larger pharmaceutical companies. He emphasized the need for MSMEs to move up the value chain and harmonize with global pharmacopeia standards in the future.