South Asia

South Asia

USP’s efforts in the South Asian region focus primarily on India, with its large and expanding manufacturing base. To facilitate and strengthen relationships with ministerial, regulatory, compendial, industrial, and others stakeholder groups, USP opened USP–India, its first laboratory and office facility outside of the United States in 2006 in Hyderabad's IKP Knowledge Park. To better serve the growing needs of the region, USP expanded the site in 2011 from 14,000 sq. ft. to nearly 97,000 sq. ft., allowing room for expanded work in analytical chemistry and collaborative testing, and support of new initiatives in synthetic chemistry, bio-analytics, and the USP Medicines Compendium.

Collaborations

Memorandum of Understanding (MOU)

  • USP and the Indian Pharmacopoeia Commission (IPC) signed an MOU in 2006 to encourage greater cooperation through exchange of information and allied activities on the quality and safety of medicines. Renewed two years later, the MOU has led to annual scientific meetings, and has helped USP establish good working relationships with  IPC's governing and scientific bodies and its laboratory in Ghaziabad. USP set up three India expert panels in connection with the Council of Experts to focus on monographs and reference materials for small molecules, biologics, and dietary supplements. In 2011, USP established an Expert Committee in India to focus on the USP Medicines Compendium.

Other Government & Association Activities

  • USP has worked closely with the State of Andhra Pradesh and has received a $1.5 million grant-in-aid to promote the availability of good quality medicines nationally and internationally.
  • Via its USAID-funded Promoting the Quality of Medicines (PQM) program, USP provides assistance to pharmaceutical manufacturers as they seek World Health Organization prequalification status for antimalarials and antibiotics.
  • USP works with authorized distributors in South Asian Association for Regional Collaboration countries of South Asia, including India.
  • USP donated USP 32–NF 27 to U.S. Navy pharmacists in support of the Islamic Republic of Afghanistan’s Ministry of Public Health Food and Drug Laboratory.
  • USP met with representatives from government agencies and industry in Bangladesh 2011 to discuss potential collaborations.

Events

  • USP has held annual science and standards meetings in India for almost a decade. 
  • The 2011 IPC–USP 10th Science & Standards Symposium generated science-based dialogue on regionally-relevant issues related to global quality standards for biologics and chemical drugs.
  • From 2005 to 2010, five meetings took place in Mumbai and Hyderabad, attracting more than 300 representatives annually from the Indian pharmaceutical industry, associations, academia, and government agencies, which participate in and cosponsor the events.
  • USP Advisory Group Meetings, Stakeholder Forums, and User Forums are held annually around India.
  • Pharmacopeial Education courses are held throughout India each year, with more than 600 participants attending. USP teams up with other organizations, including manufacturers, to advance capabilities.

Convention & Volunteer Representation

These South Asian countries have current members and/or observers to the U.S. Pharmacopeial Convention, and/or citizens who serve as USP Expert Volunteers. [KEY: M–Members, O–Observers, EV–Expert Volunteers]

  • Bangladesh (O)
  • India (M, O, EV)