Risk-Based Inspections To Be Permanent Feature: DCGI

Indore: The risk-based inspections of pharma manufacturing units and private testing laboratories will be a permanent feature to ensure best standards and safety norms are followed in the industry, said Rajeev Raghuvanshi, Drug Controller General of India (DCGI) on Saturday.

“The risk-based inspections will be a permanent feature of the system now. This was started in February and now this will be permanent. Whatever compliance is required like Schedule M or any other Schedules will come up during the inspection and audits will be carried out accordingly,” said Raghuvanshi on the sidelines of an industry event.

Raghuvanshi was in Indore to attend an award ceremony organized by the Indian Pharmaceutical Association, MP state branch, MP Small Scale Drug Manufacturing Association and Indian Drug Manufacturer’s Association, MP. Raghuvanshi said slew of regulatory measures undertaken by the Indian government post the cough syrup incidents have aided in boosting confidence of international buyers and there has been no red flag in the past 8 months.

“Things are under control and there are no red flags in the past 7-8 months. Confidence of international buyers has increased not because such incidents have not happened again but also due to various measures the Indian government has taken. This is a big industry of $50 billion and these incidents were not a systemic problem, this could have happened anywhere in the world like in Europe or the USA,” said Raghuvanshi.

He said, around 4,500 export batches were tested since July and none of them have failed the test.

“There were a total of 7 complaints and the last complaint was in July 2023. Since July, there has not been a single complaint and we have tested around 4,500 export batches and none of the batches have failed. This means things are under control,” said Raghuvanshi.

He said DCGI has focused majorly on cough syrups and its supply chain in winters due to increased consumption and reached out to 356 cough syrup manufacturers and 12 primary and 156 secondary sources of Propylene Glycol.

Raghuvanshi said revised Schedule M will foster the growth of Indian industry and aid in competing in the international market.

“We have to launch revised schedule M because as an industry we are now a global player in pharmaceuticals but schedule M was not at par with international standards and there were a few gaps. With revised schedule M we are now at par with WHO standards. This will benefit industry, aid in competing in the international market and boost exports,” said Raghuvanshi.

He said, there are 8 testing laboratories while 2 are in the pipeline and a couple of more will come up in a year.

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