New Delhi: Stressing on adopting good manufacturing practices, Union Minister Mansukh Mandaviya has asked the pharmaceutical firms in the MSME segment to move towards best practices through self regulation.
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, adding 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.
On the basis of assurances given by the industry representatives, Mandaviya noted that Schedule M should be made compulsory for the MSME pharma sector in a phased manner as it would help in quality assurance and reduce compliance burden.
Stressing that there should be no compromise with the quality of drugs manufactured in India, Mandaviya said that he has directed the Drugs Controller General of India (DCGI) to take stringent action against all pharmaceutical manufacturing companies that make spurious drugs.
Mandaviya further noted that in order to ensure the highest quality of pharma products, the regulatory authorities have started risk-based inspection and audit of plants as after inspecting 137 firms, 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 said, adding that in addition, showcause notices have been issued to 73 firms, and warning letters have been issued against 21 firms.