Pharmaceuticals

PHARMACEUTICALS – A BRIEF OUTLINE

In India, pharma sector is governed by the D&C Act, 1940 and D&C Rules, 1945.  Even though pharma industry has metamorphosised over and over in the last few decades, the pre-independence legislation (“D&C Act and Rules”) 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 a mine field; especially as violation of the regulatory regime, invites penal consequences for the manufacturer/ distributor and Directors etc.

Also, ‘drugs’ including all medical devices (notified as drugs under the D&C Act on February 11, 2020) fall within the scope of price regulation/control under the Drugs Price Control Order, 2013, which provides enormous power to the Regulator (National Pharmaceutical Pricing Authority). Under the DPCO, 2013, the NPPA has the power also, to monitor the prices of non-scheduled formulations (which are not listed in the First Schedule to the DPCO, 2013).  In addition, emergency powers have been exercised on multiple occasions, under Para 19 of 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, PRA Law provides its expertise to some of the largest pharmaceutical and medical device companies which have a presence in the Indian market and was involved in several of the challenge before Court, in Pharma industry.

HOW WE CAN HELP YOU

Services provided by PRA Law to its Clients from pharma/medical device sector & healthcare, include:

  • Advisory in relation to strategizing & compliance requirements for manufacture, sale, distribution, marketing, import of drugs/medical devices, including pricing and other issues for scheduled/ non-scheduled formulations under the DPCO, 2013
  • Compliance and regulatory services regarding labelling cosmetics and pharmaceuticals under Legal Metrology Act, 2009, Drugs and Cosmetics Act, 1940, Medical Devices Rules, 2017, Drugs (Price Control) Order, 2013, among others
  • Advisory and assistance provided to hand proceedings initiated by regulatory authorities including DCGI, CDSCO, NPPA, State Drug Controllers from the stage of obtaining approval, testing etc
  • Handling litigation including challenge to action initiated regulatory authorities, challenge to Price Control Orders before Review Authority (NPPA), District Courts, High Courts, Supreme Court
  • Conducting comprehensive due diligence of the business of the Client in relation to its compliance vis-à-vis the D&C Act, MDR, 2017, DPCO, 2013, LM Act, 2009 among others