Pharma Laws

In India, pharma sector is principally governed by the D&C Act, 1940, D&C Rules, 1945, Medical Device Rules, 2017 Drugs Price Control Order, 2013. Even though pharma industry has transformed over and over in the last few decades, the pre-independence legislation (“D&C Act and Rules”) to a large extend continues to govern the manufacture, distribution and sale of drugs in India. The multiple piecemeal amendments to the D&C Act and D&C Rules and the Medical Devices Rules, 2017 have made Drugs Laws an open mine field; especially since violation of the regulatory regime, invites penal consequences for the manufacturer/ distributor and Directors etc.

Also, ‘drugs’ including certain medical devices (notified as drugs under the D&C Act) fall within the scope of essential commodity under the Essential Commodities Act. The Govt. of India has replaced the Drugs Prices Control Order 1995 with Drugs Prices Control Order 2013, with more teeth to the Regulator (National Pharmaceutical Pricing Authority). Under the DPCO, 2013, the NPPA has the power also, to monitor the prices of formulations, which are not listed in the Schedule to the DPCO, 2013. Several compliance requirements have been introduced from time to time and non-compliance invites recovery of large amount(s) with interest and penalty.

India experienced the fastest growth rate for pharmaceuticals and medical devices sector in the last decade. The Government has initiated several measures for stricter compliance for the pharma sector and the regulatory regime is getting more complex. In light of the dynamic and complex laws that deal with drugs and medical devices, J-Law provides its expertise to some of the largest pharmaceutical and medical device companies which have a presence in the Indian market.