Against the backdrop of cough syrup-linked incidents being reported internationally, an association of 24 large domestic drugmakers has called for the implementation of revised norms involving manufacturing, besides aligning with international regulatory practices.

The revised Schedule M norms must be brought in and India should align with PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) and ICH (International Council for Harmonisation of technical requirements for pharmaceuticals), said Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, which represents domestic drugmakers that contribute to 80 per cent of the country’s pharmaceutical exports and 85 per cent of private investment in pharma research.

Also read: Cough syrup suspected of killing 12 kids in Cameroon might be made in India

He was speaking ahead of the IPA’s two-day Quality Summit in Mumbai, its eight edition, that will see the participation of representatives from multiple regulatory authorities, including India, the US and Europe. Union Health Minister Mansukh Mandaviya is scheduled to address this gathering, Friday.

Pre-shipment tests

The conclave comes even as Gambia’s Medicines Control Agency (MCA) calls for all imported pharmaceutical products from India to be quality tested before it is shipped into the country from July 1.

This follows the death of at least 70 children, possibly from poor quality cough syrups made in India. The MCA has appointed Quntrol Laboratories, a verification, inspection and testing company, to carry out pre-shipment document and physical inspections. Industry representatives said, the agency did testing for Nigeria too. Over the last several days, Nigeria’s regulatory authority also red-flagged two products from India.

Also read: WHO says contaminated cough syrup made in India found in Western Pacific

The Indian government has also instituted pre-export tests for cough syrups from designated laboratories, from earlier this month. However, regulatory and industry officials pointed out, it could create a backlog and would not address the core of the problem, which was quality sourcing and manufacturing.  

Global contribution

Meanwhile, IPA officials pointed out that every third medicine in the United States and fourth in Europe was from India. And, India had over 530 manufacturing sites in the country that were US Food and Drug Administration approved.

Speaking for IPA members, Jain said they accounted for about $100 million of the $546 million collected as GDUFA fees by the USFDA and had invested about $4 billion in the US (2019). Of the $373 billion in US savings from generics and biosimilars in the US, India contributed about 30 per cent (2021).

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