Good manufacturing practices (GMP) and Compliance: Issues in some manner these are always been a problem for the drug companies. The current going bruit that the USFDA (United States Food and Drug Administration is trying to block the growth of the Indian drug firms.

Why Indian firms having dependency of USFDA?

USFDA approval is vital as the largest medicine users in the United States of America and at the same time India is a major exporter to them. The view of the USFDA is carefully weighed to be the standard in the biopharma field as well. The Indian drug companies putting efforts to ameliorate their standards and GMP, compliance challenges could be sorted by having functionaries who are more rigorous or strict and inspections on a regular manner can be planned and executed fragmented sector.

India is the source of 60,000 generic brands across 60 therapeutic categories and manufactures more than 500 different Active Pharmaceutical Ingredients (APIs). The export of generic drugs is one of India’s core strengths. The export of pharma stood at USD 16.3 bn in 2015-16.

Pharma exports recorded CAGR of 11.9% for decade ending 2015-16. Third largest pharmaceuticals market by 2020 in terms of incremental growth 100% Foreign Direct Investment (FDI) is allowed under the automatic route for green field pharma and 74% FDI in brownfield pharma under automatic route, beyond 74% FDI is through government approval route.

Policy Regime

Pharma sector exports recorded CAGR of 11.9% for decade ending 2015-16. Third largest pharmaceuticals market by 2020 in terms of incremental growth 100% Foreign Direct Investment (FDI) is allowed under the automatic route for green field pharma and 74% FDI in brownfield pharma under automatic route, beyond 74% FDI is through government approval route.