Schedule M to be made compulsory for MSME pharma sector

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The centre is preparing to make Schedule M under the Drugs and Cosmetics Act compulsory for pharma companies to help in quality assurance and reduce the compliance burden.

At a meeting with representatives from Pharma companies from the MSME sector on Tuesday, Union health minister Mansukh Mandaviya said, “This will help in quality assurance and also reduce compliance burden”. He said that all possible steps must be taken to maintain the highest quality of products for global positioning in the pharmaceutical sector.

Stressing the need for self-regulation in the MSME pharma sector, the Union Minister underlined the importance for India to maintain the status of ‘Pharmacy of the World’. “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 stated in the meeting with MSME representatives.

The DCGI has also been directed to take stringent action against all pharmaceutical companies involved in the manufacture of spurious drugs. In a bid to ensure the highest quality of pharma products, the regulatory authorities have started risk-based inspection and audit of plants. Out of total 137 firms inspected, action has been taken against 105 firms, while 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. 

Dr Mandaviya said that there shall be no compromise with the quality of drugs manufactured in India. Highlighting 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 has been taken.