Aimed at ensuring robust quality of pharma products, the Union Minister of Chemicals and Fertilizers Mansukh Mandaviya has directed regulatory authorities to conduct risk-based inspection and audit of manufacturing plants. He also added that Schedule M shall be made compulsory for the MSME pharma sector in a phased manner.
“This will help in quality assurance and also reduce compliance burden,’’ he said.
Schedule M part of Drugs and Cosmetics Act 1940 deals with ‘Good Manufacturing Practices’ for pharmaceuticals that should be followed by pharmaceutical manufacturing units in India.
Meanwhile, as part of the quality control drive launched across the country, 137 firms were inspected and action has been taken against 105 firms. Production has been stopped at 31 firms and cancellation & suspension of product/section licenses have been issued against 50 firms. In addition, show cause notices have been issued to 73 firms, and warning letters have been issued against 21 firms,’’ said a release issued by the Ministry on Tuesday.
The statement comes following a meeting of the Minister with representatives from Micro, Small and Medium Enterprises (MSME) pharma companies, and the Minister also stressed on the need for self-regulation in the MSME pharma sector.
“It is important for MSME pharma companies to be alert to the quality of drugs and expeditiously move towards Good Manufacturing Processes (GMP) through self regulation,” said Dr. Mandaviya.
Strongly stressing the need for self regulation in the MSME pharma sector, the Union Minister underscored its 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.
