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. The National Drug Authority will be structured similarly to the U.S. Food and Drug Administration (FDA). It will be the regulatory body for setting standards and regulating the quality of drugs, pharmaceuticals, and cosmetics in India.
The establishment of a centralized drug control system overseen by a national regulator is a response to the recommendation by the Mashelkar Committee; a group of experts that recently met to examine the drug regulatory system in India. The regulation of drugs is currently decentralized, with individual state drug authorities reporting to the Drug Controller General of India. This system has led to inconsistency in the enforcement of drug laws and the quality of drug testing throughout the country.
The proposed legislation for a centralized drug regulatory body is expected to obtain cabinet clearance, and the goal is for the National Drug Authority to become functional by mid-2007. The National Drug Authority would administer all activities related to granting approval, licensing, blood, vaccines, drugs and medical equipment. It has been proposed that the National Drug Authority also oversee the quality of food products. The drug regulatory authority will most likely be comprised of 10 departments each overseeing issues such as drug safety, licensing, industrial systems, and medical devices. The drug authority will be managed by approximately 150 professional experts, representing consumers, academia, the general public, and affiliated professional organizations. The government hopes that within the next five years all licensing of drugs and drug manufacturers will be done by the National Drug Authority, as initially proposed by the Mashelkar Committee report.