Updated on 16 April 2012
In recent years, licensing and quality control for manufacturers and national regulatory authorities has become more complex. The National Institute of Biologicals (NIB) has been working since 1992 as an autonomous organization under the Ministry of Health and Family Welfare, Government of India, to strengthen the regulations on biologicals in India. The institute assures and reviews quality of biological products available through domestic manufacturers and importers. The operations are carried out in the state-of-the-art facility of the institute and in close co-ordination with government regulatory authorities, such as the office of Drug Controller General of India and the Indian Pharmacopeia Commission.
Indian companies are ramping up their facilities in adherence to quality standards for both the regulated and unregulated markets of the world, but they still have a long way to go. "One area that could be improved upon is the availability of more current good manufacturing practices (cGMP)-approved manufacturing facilities," says Mr Chinny Rao, executive director, Transgene Biotek. "This can sometimes sit alongside a dearth of knowledge concerning the exact standards and parameters prescribed by foreign regulators, and the absence of government support in dealing with or overcoming foreign government restrictions on imports. In commercial terms this just adds to delays in manufacturing time lines and also cost increases."