After Auditing 90% of Cough Syrup Units, CDSCO Tightens GMP Net, 850 CAPA Notices Served

Speaking at the 11th edition of the Global Pharmaceutical Quality Summit here, he also said that the companies' sites are now being audited by both the state and the Central regulator under the revised norms for good manufacturing practices and requirements.

"We practically audited more than 90 per cent of cough syrup manufacturers in this country. There are about 1,300 plus manufacturers who were manufacturing cough syrups, and till now we have audited 1250 of them physically going to their site, and as we do in risk-based inspection, we took serious actions on serious non-compliances," Drugs Controller General of India, Rajeev Singh Raghuvanshi, said.

"Our belief is that the rot of cough syrup manufacturing will be removed from next season and we will be out of the issues of cough syrup manufacturing," he said.

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On the risk-based inspection, he said that the CDSCO has completed 1,250 sites audit and multiple actions depending on non-compliances, extent of non-compliances have been taken.

Raghuvanshi said that the implementation of revised Rule M, which is in force for all the companies with all the extensions would have a long term impact on the domestic pharmaceutical industry and on quality of medicines being produced here for the global market.

In an effort to ensure adherence to quality control and compliance with regulatory norms, the authorities have served about 850 CAPA (Corrective and Preventive Action) notices in the last about 10 months but have not yet received any satisfactory response to any such notice, he said.