Close on the heels of the US FDA who is setting up its regional office in India, the US Pharmacopeia Convention Inc is planning to set up its office including a laboratory in India, said reliable sources with the DCGI.

Recently, a USP team visited cities like Delhi, Mumbai, Bangalore, Chennai and Hyderabad and are in the process of finalising a place to set up its office in the country. Once set up, it will be a first of kind of USP office outside US, said sources.

According to sources, USP is thinking of making India a hub for making quality reference standards. Making of new standards, upgradation of the existing standards, training and consultancy could also be done from India, said sources.

"India is already an API hub of the world. USP could explore on the possibility of outsourcing reference standards and reference substances from the country. As these activities require an extensive analytical work, it is understood that USP will have its own lab in the country," said a senior official with Mumbai-based JB Chemicals & Pharmaceuticals.

After the new office comes into existence, Indian Pharmacopeia and USP could collaborate for creating better reference standards for the Indian condition, he added.

Moreover, as of now, officials of Indian companies had to rush US for any consultancy regarding USP. Now, the consultation could be made straight from India office once it is set up. "An Indian office of the USP will definitely enhance the communication and increase convenience of Indian drug companies with USP," said Dr. PG Shrotriya, technical advisor to Alkem Labs. Thus it will be a win-win situation for both the parties, he added.

USP provides standards for more than 3,800 medicines, dietary supplements and other healthcare products. A majority of Indian pharma companies rely on USP for standards.

Indian companies' association with the USP is traditional. A majority of Indian companies refer to USP standards for their products. It is mandatory to use USP or BP (British Pharmacoepia) as standards for products exported out of the country.

USP also selects pharmaceutical scientists and manufacturing experts from around the world to be members of the Expert Committees of USP's Council of Experts. This is the primary decision-making body of USP and is responsible for the content in United States Pharmacopeia-National Formulary (USP-NF). USP also encourages manufacturers, government experts, and other experts from all countries, including India, to comment on draft monographs and General Chapters in USP's Pharmacopeial Forum.

More recently, USP has worked with many trade associations in India, including OPPI, IDMA, IPA, BDMA, SAPEC, and the Drugs Controller General Office to form the Indian Quality Communications Group. The group first met in December 2001 and conducted its second meeting on September 22, 2002. This new group provides an excellent opportunity for information sharing and gives specific attention to topics of special interest.