In October 2005, the Indian Ministry of Health and Family Welfare issued notifications that essentially constitute the regulation of medical devices. The notifications amended the Drugs and Cosmetics Act of 1940 by reclassifying certain medical devices as drugs in order to bring... Read More
The Indian government has announced that it will create a new independent drug regulatory authority, to be called the Central Drug Administration or the National Drug Authority, which will be structured similarly to the U.S. Food and Drug Administration (FDA). India’s Minister... Read More
As competition in the global medical device market intensifies, U.S. medical companies are increasingly seeking out ways to reduce costs in manufacturing, R&D, clinical trials and other medical services. Many Asian countries offer a lower cost of labor (China and India) and... Read More
With the introduction of India’s new patent regime in January 2005, multinational pharmaceutical companies are increasing their presence in the Indian drug industry. The number of global pharmaceutical companies looking to benefit from partnerships with Indian companies has been increasing steadily. Indian... Read More
India’s Parliament is expected to pass the long-awaited Third Patent Amendment Bill in January 2005, providing for more transparency and security in India’s six billion dollar pharmaceutical industry, comprised of around 20,000 foreign and domestic drug makers. The Third Amendment Bill will... Read More
Many companies look to India for clinical trials, as the country offers a large, diverse population and varied gene pool. Therefore, patient recruitment is often an easier and faster process in India than in the West and companies can save as much... Read More
With the growth of Asian economies spurring on the expansion of Asian medical markets, medical and pharmaceutical companies in the West are increasingly looking to Asia for outsourcing. Western medical device and pharmaceutical companies have begun to outsource research and development, clinical... Read More
In a move to ensure standards of quality, efficacy and safety in medical products, India’s Central Drug Standard Control Organization has revised its guidelines on bioequivalence and bioavailability for pharmaceuticals. The revisions will become part of Schedule Y of the Drugs and... Read More
Home to a booming population and low costs, India is rapidly becoming a preferred destination for drug companies to conduct clinical trials quickly and cheaply. Performing clinical trials in India can be 50%-60% cheaper than in North America or Europe. Other practical... Read More
A panel headed by Dr. R.A. Mashelkar, Director General of the Council for Scientific and Industrial Research (CSIR), recommended in its report that Phase I clinical trials be allowed in India concurrently as they are being conducted abroad. Phase I clinical trials... Read More