CURRENT SCENARIOS ON REGULATORY LANDSCAPE OF INDIAN PHARMACEUTICAL INDUSTRIESAbstract
India is the fourth largest generic pharmaceutical market in the world. Indian pharmaceutical industries are very well established in today’s world and continuously producing a variety of products, which are useful in the treatment of various diseases and grabbing the market segments. India has a large number of resources to contribute vitality in the research and manufacturing process, and due to its large patient population & genetic pool, now it has become a region for cost-effective and speedy Clinical Trials (CTs) for Investigational New Drugs (INDs). Due to having these significant advantages, India now able to contract multinational pharmaceutical companies (MNPCs) to outsource operations in the fields of drug discovery and also able contract manufacturing and clinical research (CR) to organizations in India. On the other hand, understanding the regulatory scenario is not easy because the rapid and ongoing changes and the burden on the regulatory bodies to ensure a healthy supply of quality drugs at affordable prices to the population. The Indian pharmaceutical industry has shown impressive growth over the last few years and has become one of the sunrise sectors of the Indian economy. Indian generics companies supply 84% of the AIDS drugs that doctors without borders use to treat 60,000 patients in more than 30 countries. This article mainly focuses on the current scenario of various pharmaceutical industries and the different regulatory bodies conducting the Indian pharmaceutical system.
Bramhajit Chatterjee *, Biswajit Dash, Bhupendra Shrestha and Nihar Ranjan Bhuyan
Department of Pharmaceutical Technology, Brainware University, Barasat, Kolkata, West Bengal, India.
28 September 2020
24 April 2021
25 May 2021
10.13040/IJPSR.0975-8232.12 (11). 5642-51
01 November 2021