New Delhi: The Centre has stopped production of drugs at 31 firms and cancelled or suspended the product licenses of 50 firms on finding non-adherence to quality control norms. In addition, sources said, showcause notice has been issued to 73 firms, and warning letters have been issued against 21 firms.
The action is result of a nationwide inspection of drug manufacturing units identified to be at the risk of manufacturing Not of Standard Quality (NSQ)/adulterated/spurious drugs being carried out by drug regulatory bodies in the backdrop of recent controversies over alleged adulteration found in certain products, mainly cold and cough syrups, exported abroad, the sources said. A committee of two joint drug controllers has been constituted at the Central Drug Standard Control Organisation headquarter to monitor the process of inspection, reporting and subsequent action so as to ensure compliance to the Drugs & Cosmetics Act, 1940 and Rules thereunder.
“It is important for MSME pharma cos. to be alert to quality of drugs and expeditiously move towards good manufacturing processes through self-regulation,” Mandaviya said.
He also directed the DCGI to take stringent action against all companies that make spurious drugs. “There shall be no compromise with the quality of drugs manufactured in India”, he said.