The report of the United States' Food and Drugs Administration (USFDA) on the functioning of Ranbaxy Laboratories' plants at Paonta Sahib in Punjab and Dewas, Madhya Pradesh, played a vital role in the indictment of the pharmaceutical company by the US's Department of Justice. Ranbaxy settled by paying a $500 million fine. In an emailed response to E. Kumar Sharma's questions, the USFDA informs that it is planning to expand its presence in India, including setting up another office in the country, in Hyderabad. (The email is signed by an official from the office of Media Affairs of the USFDA, Christopher C. Kelly.) While the USFDA did not reveal the precise number of pharmaceutical units it monitors in India - all those whose products sell in the US - the Drug Controller General of India revealed that there were 169 such approved plants. Excerpts from the responses:
On whether the USFDA would conduct more frequent inspections of Indian pharmaceutical companies after the Ranbaxy case
In March 2013, the FDA received approval from the Indian government to add seven additional drugs investigators (to its team) in India. We are currently recruiting and training staff for these positions. With this, the FDA's presence will grow from 12 to19 American staffers based in the country, including 10 dedicated specifically for medical products. The other staff includes foods and devices inspectors, and policy analysts.
New and updated laws in the US require the FDA to achieve the same inspectional schedule for foreign facilities as for domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorization period. Having these additional inspectors in-country will assist the agency in meeting our legislative mandates.
On its experience with the manufacturing quality standards of Indian companies
India's success in providing a significant share of the generic products used in America, and the growing percentage of India's exports to the US are ample evidence of the Indian pharmaceutical sector's ability to meet US standards and regulations. The FDA remains confident that many companies understand and have implemented Good Manufacturing Practices (GMPs). We also remain vigilant and will take appropriate action if, or when, lapses occur.
On plans to expand its physical presence in India
The FDA will increase its activities in India. It is exploring the opportunity to open an additional office in Hyderabad. Through a variety of methods, including scientific reviews, inspections of facilities and post-market surveillance, FDA strives to ensure that regulated product manufacturers, wherever they may be located, comply with standards and regulations for their products provided to US consumers.
On how USFDA has been transforming itself
FDA has been transforming from a domestically-focused agency to a proactive, global public health agency in order to carry out our mission more effectively in a world where trade - and product safety and quality - have no borders. The regulation of medical products today requires a global effort, and that's why the FDA has opened offices and posts around the globe, including India.
On why India matters in pharma
India, as the second largest provider of finished dose products to the U.S. with almost 10 per cent of the market, has for many years been a consistent provider of low-cost and quality medical products for many countries of the world. FDA seeks to ensure that Indian manufacturing facilities importing to the US understand the risks associated with their product's processes and ensure they remain compliant to FDA's regulations.
Our presence in India allows us to better collaborate with our Indian regulatory counterparts and enables us to leverage our combined resources, harmonize science-based standards and increase regulatory capacity. In doing so, FDA continues to ensure that medical products moving in international commerce are safe, effective, and of high quality.