Roger L Williams, Executive Vice-President and Chief Executive Officer of US Pharmacopeia (USP), said that the National Regulatory Authorities of the US and India could work together to the benefit of both countries. USP guidelines would help India get into the regulated markets. He said many of the active pharmaceutical ingredients (APIs) came to the US from India. Besides many scientists also worked in the US who was familiar with the USP guidelines.
While USP could help India evolve international standards, the Indian research organisations could carry out tests for USP on new compounds. There were several other fields on which both IP (Indian Pharmacopeia) and USP could work together, he said. He also stressed the need for evolving a uniform standard for the pharmaceutical industry.
He was speaking at the inauguration of the two-day international conference on Pharmacopeial Standards for Bulk Pharmaceuticals organised by the Drugs Controller-General of India, Indian Drug Manufacturers Association (IDMA), Bulk Drug Manufacturers Association (BDMA), Indian Pharmaceutical Alliance (IPA), the Organisation of Pharmaceutical Organisation of India (OPPI), the Indian Pharmacopeia and the United States Pharmacopeia (USP).
More than 250 delegates are attending the conference from the industry, exporters of bulk pharmaceuticals, regulatory agencies, academia, and other interested parties. There are delegates from the US, Canada, Bangladesh, Sri Lanka, Mauritius and Thailand.
Following is extracts from the speech of Roger Williams:
USP is extremely pleased to attend this important meeting on Pharmacopeial Standards for Bulk Pharmaceuticals. It is one of many ways that USP can work effectively with Indian pharmaceutical manufacturers, the Indian Pharmacopeia, and the Drugs Controller-General of India office. To list some of these: In ICH (International Conference on Harmonisation), when I was at FDA, I strongly encouraged participation of representatives from India in the ICH Q7A working party that developed a GMP guidance on APIs. In addition, the USP Convention, which meets every five years, welcomes representatives from governments and pharmacopeials throughout the world, including India.
At the 2000 Quinquennial Meeting, we were delighted that Aswini Kumar, Drugs Controller-General of India, was able to attend the meeting. 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, the Indian Pharmacopeia, 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.
USP was delighted to participate in this group and expects to learn a great deal form working with the pharmaceutical experts in India. Finally, USP welcomes visitors from India to the USP Headquarters in Rockville Maryland, which is just north of Washington DC and very near the FDA main building. Overall, USP wishes to work very closely with Indian manufacturers and the Indian government. USP acknowledges the success of the Indian pharmaceutical industry, which provides many bulk drug substances and, more recently, finished dosage forms for the US market. USP strongly supports good quality pharmaceuticals and harmonization efforts that will allow all manufacturers to meet the same, science-based pharmacopeial and other standards. These standards help assure patients and practitioners that they will have available safe, effective, and high quality pharmaceutical products to prevent and treat disease.