New Delhi: The Centre will make ‘Schedule M’ compulsory for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing which will help in quality assurance and also reduce compliance burden in the pharma sector. Schedule M lays down Good Manufacturing Practices that such units must adhere to.
Health minister Mansukh Mandaviy a chaired a meeting with pharma companies from the MSME sector and industry representatives on Tuesday.
“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,” Mandaviya said. “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.”
Schedule M will be made compulsory for the MSME pharma sector in a phased manner.
“There shall be no compromise with the quality of drugs manufactured in India”, the minster said. “The government has zero tolerance for manufacturers not adhering to quality compliance and making spurious medicines. Special squads have been formed to inspect drugs making companies and stringent actions has been taken.”
Regulators have started risk-based inspection and audit of plants. Over the last few months, around 137 firms were inspected and action has been taken against 105.
“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,” as per an official statement.
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