Abstract

AN OVERVIEW OF REGULATORY AFFAIRS IN INDIA

K. Soundharrajan*, D. Silambarasan, D. Mohan Kumar and R. Venkadesan

Abstract

Pharmaceutical drug regulatory affairs covers different registration parameter of pharmaceutical product. As it is the new profession which was developed from the desired of all over the world to protect the public health by providing good quality of medicine including safety and efficacy in the area of not only pharmacy but also in the area of the veterinary medicine, medical device, insecticides, pesticides, agrochemical, cosmetic and complementary medicine. It also made the interface between the pharmaceutical company and the regulatory agencies. It is also responsible for maintaining the appropriateness and accuracy of the product information. And its main role to act as an liaison with regulatory agencies, providing expertise and regulatory intelligence in translating regulatory requirement into practical workable plan, advising the company on regulatory aspects and climate that would affect their proposed activities.

Keywords: Regulatory affairs in India, MHFW, CDSCO, DTAP, DCC.