Indian drug makers may now get an easier access to global markets, including the US, with the US Pharmacopeial Convention (USP), a non-profit organisation that sets standards for quality and safety of medicines, opening its expanded Indian testing facility in Hyderabad on Friday.

Expanded at a cost of $ 14 million, the Hyderabad laboratory, USP’s second biggest after its facility in the US, will be undertaking collaborative and verification testing of medicines produced in the country to attest whether the drugs conform to USP standards.

“Indian exporters of pharma products can export to the US and other markets with the USP certification directly. Medicines not covered by the Indian Pharmacopeia can also be tested at our facility here,” Mr Roger Williams, USP’s Chief Executive Officer, told media persons.

Indian medicines may also become cheaper, as pharma companies can save costs of getting the drugs tested in different countries in accordance with their regulations by getting the USP stamp. Mr Williams said the Hyderabad facility will be playing a more active part in USP’s global verification programmes, especially for dietary supplements.

Dr B. Suresh, chairman on the Indian Pharmacopoeia Commission’s Scientific Body, said it had so far established 1900 monographs in India so far. A drug monograph is a detailed explanation of a drug that is usually accompanied with the prescription medication and contains information about the structure, function, uses and dosing.

“In the next five years, we aim to come out with 3,000 monographs,” he said. The commission was also coming out with an on-line National Formulary of India, a publication that contains the right dosage of medicines, to help doctors, chemists, nurses and students. It will be expanding its network of 40 pharmaco vigilance centres to 100 by 2012 to report on drug withdrawals and side-effects reported from different hospitals across the country.

(This article was published on September 2, 2011)
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