USP-India Celebrates a Decade of Public Health Impact by Advancing the Quality of Medicines in India



Panel discussion on The Value of Indian Pharmaceuticals for Global Public Health marks the celebration

Hyderabad, India, February 12, 2016 — The United States Pharmacopeial Convention (USP) today celebrates the 10th anniversary of its laboratories and office in Hyderabad, India. USP-India started operations in 2005 and was the first USP facility outside the U.S., marking the global expansion of USP and its commitment to improving global public health and the quality of medicines, foods and dietary supplements through science-based quality standards and partnerships with regulators, the NGO sector and industry. Today, USP-India has a 100,000 square foot laboratory and operations site, and employs more than 140 professionals in Hyderabad.

To celebrate USP-India’s accomplishments during the last decade, leaders from government and the pharmaceutical community participated in a panel discussion on the positive impact of the Indian pharmaceutical sector on global public health. Panelists included Dr. Mathew Thomas, U.S. Food and Drug Administration director in India, Dr. Kiran Mazumdar Shaw, CEO of Biocon Limited and Mr. K L Sharma, Joint Secretary in the Ministry of Health and Family Welfare.

India’s pharmaceutical industry can be proud of being a leading supplier of medicines both to India’s domestic market and around the world. In fact, India is the largest exporter of drugs to fight life-threatening diseases such as HIV, malaria and TB to emerging markets, helping these countries’ health systems reduce the burden of disease. To further this legacy of positive impact, it is important to continue to ensure that the medicines manufactured in India meet high quality standards to protect patients and improve public health.

USP-India plays an important role in ensuring that medicines manufactured in India are available in markets worldwide through the “Promoting the Quality of Medicines” (PQM) program where USP provides assistance to pharmaceutical manufacturers as they seek World Health Organization (WHO) prequalification status for essential medicines such as antimalarials and antibiotics. Funded by the United States Agency for International Development (USAID) and implemented by USP, PQM assists with dossier preparation, discussion facilitation and guidance on compliance with WHO’s Good Manufacturing Practices.

“USP recognizes the important role that India plays in today’s global pharmaceutical environment. Quality healthcare depends on the availability of quality medicines to combat the world’s most pressing public health concerns,” said Ron Piervincenzi, Ph.D., chief executive officer, USP. “USP looks forward to continuing to be an important partner to India in support of good quality medicines. Today, we celebrate USP-India’s impact on public health through partnerships with government and industry. We look forward to continuing our work together to increase our impact as we advance our shared goal of better public health through quality medicines.”

During the last decade, USP-India has partnered with Indian regulators and industry to help ensure the quality of both generic and innovative medicines and to promote globally accepted quality standards. An example is USP-India’s work with the states of Andhra Pradesh and Telangana to support local industry and promote the availability of good quality medicines nationally by providing research and development support on materials characterization to help interested local manufacturers.

As a scientific nonprofit organization, USP sets quality standards for medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide. USP quality standards are used by manufacturers, regulators and other stakeholders in 140 countries.

“Pharmaceutical exports from India reach over 200 countries,” noted K.V. Surendranath, senior vice president, USP Global Sites and senior vice president, USP-India. “As the ‘pharmacy of the world’, India must ensure that its products meet not only public health needs in the markets it serves, both domestically and abroad, but also that the pharmaceutical ingredients and products the country exports are of high quality. USP-India plays a pivotal role in helping to ensure that.”

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