With soaring clinical trial costs and long development periods, many companies have turned to India to conduct cheaper, faster clinical trials. The potential cost savings of 40 to 60 percent together with a large, ethnically diverse population and an increasing pool of... Read More
On March 1, 2006, a set of guidelines on the import and manufacture of medical devices, issued by the Drug Controller General of India (DCGI), became effective in India. (Subsequently, the effective date was postponed to June 30, 2006) Ten common sterile... Read More
As part of a new pharmaceutical policy proposed by the Indian government, medical device manufacturers could face new price restrictions when selling to public-sector medical institutions. In the new policy, high-price, critical medical devices would come under a differential pricing system, to... Read More
The Indian government has issued an order to change the Drugs Prices Control Order (1995) that will change the new maximum retail price (MRP) for drugs. Pharmaceutical companies will now have to comply with the new MRP system as of July 2006—all... Read More
Asia has a population of over 4 billion people, and represents about 60% of the world's population. Annual economic growth rates in the Asian countries have been as high as 8 or 10% over the past decade, in comparison with some developed... Read More
On April 28, 2006, the Indian government extended the last date for device registration from April 30, 2006 to June 30, 2006. This extension gives medical device manufacturers, who have devices that now require registration in India, about 2 more months to... Read More
The import and manufacture of medical devices in India is now regulated by guidelines issued by the Drug Controller General of India (DCGI). New medical device guidelines, which went into effect on March 1, 2006, outline the procedures and requirements for importing... Read More
India’s Department of Chemicals and Fertilizers, the administrative ministry for the pharmaceutical industry, recently released a draft of the National Pharmaceuticals Policy 2006. The draft was presented at the first meeting of the Pharmaceutical Advisory Forum on February 11, 2006. The draft... Read More
The Indian government has recently announced that its proposal for establishing a National Drug Authority will likely be in effect by mid-2007. According to India’s Minister of Health and Family Welfare, the legislation will soon be introduced to the Cabinet for approval.... Read More
The Indian government has proposed the creation of a new agency to monitor and raise standards for clinical trials conducted in India. India’s Science and Technology Minister Kapil Sibal met with the U.S. FDA in August 2005 to request its assistance in... Read More