The local subsidiary called US Pharmacopeia-India will collaborate with its parent-outfit to educate local companies on reference standards, besides supporting USP's existing customers.

P.T. Jyothi Datta

Mumbai, Sept. 14

DOMESTIC drug companies active in global markets have caught the eye of multinational drug lobbies and regulatory authorities.

Now, the US Pharmacopeia (USP), a scientific body, has set up a wholly owned subsidiary in India, a first time of sorts for the standards-setting outfit.

Explaining why USP chose India as its first overseas venture, Mr John Fowler, USP's Chief Business Officer and Senior Vice-President told Business Line: "India is the right place to go because of the significant growth and the number of companies that are exporting to other parts in the world."

Though USP is a non-governmental organisation, its standards are mandatory for drug companies in the US, where it is the official pharmacopeia, he said.

USP sets the standards that are then enforced by the regulatory authority, the US Food and Drug Administration, he added.

Establishing standards is a core USP activity and now it provides standards for more than 4,000 prescription and non-prescription drugs, dietary supplements, veterinary drugs, and healthcare products.

These standards are published in the United States Pharmacopeia and National Formulary (USP - NF), which are officially recognised in the Federal Food, Drug, and Cosmetic Act.

It is significant that USP is setting foot in India, as it could work with companies to bring out quality, safe and effective medicines not just in the export, but also in the domestic market, Mr Fowler said.

USP standards are used in 130 countries and it has a business office in Europe, he said.

The local subsidiary is called United States Pharmacopeia-India Private Ltd and is located in the ICICI Knowledge Park in Hyderabad, Andhra Pradesh.

USP will also have its laboratory at the same location.

Elaborating on the significance of the India office, USP India's newly appointed head, Ms Kumud Sampath, said that the local office would be up and running in the first quarter of 2006.

USP-India would work with the Indian Pharmacopeia to improve the quality and reference standards for pharmaceutical ingredients, she said.

The local subsidiary will also collaborate with its parent-outfit to educate local companies on reference standards, besides supporting USP's existing customers, including Dr Reddy's Laboratories, Ranbaxy, Lupin and Cipla, she said.

USP-India will also provide its range of pharmacopeial services to USP customers in neighbouring countries.

Some of the other facilities that USP offers globally include collaborating and analysing data on medical errors towards patient safety; verification for dietary supplements and healthcare information on the use of medicines, besides, other global initiatives.

(This article was published in the Business Line print edition dated September 15, 2005)
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