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There is a need for uniform regulatory standards for drugs across the globe, according to Mathew Thomas, Director, US Food and Drug Administration (USFDA), India.
He was speaking at an event organised as part of the 10th anniversary of US Pharmacopeial Convention (USP) here recently.
Referring to divergence in regulatory standards among the countries, he said there should be same standards of drug quality. This will help the industry as well the regulatory agencies. About 40 per cent of generic drugs from India are exported to the US.
P V Appaji, Director-General, Pharmaceutical Export Promotion Council of India, said the Centre sought to help drug makers adhere to global standards even while improving the affordability of their products.
Executive Director of Serum Institute of India Pvt Ltd, Suresh Jadhav, said the regulatory framework in the US acted as “some kind of barrier” for biological products from India, despite the vaccine manufacturers conforming to the norms laid down by World Health Organisation (WHO).
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