Regulatory Organization & Sector Policy for Pharmaceuticals in India

Regulatory Organization for Pharmaceuticals in India

Pharmaceutical Registration in India1

A Pharmaceutical Company has to comply with various regulatory aspects in India 1

SUMMARY (Pharma Industry IN INDIA)

  • Third largest pharmaceuticals market by 2020 in terms of incremental growth.
  • 20% of global exports in generics, making it the largest provider of generic medicines globally.
  • USD 45 Billion in revenue by 2020, revenue of USD 55 billion by 2020 as base case, and can grow to USD 70 billion in a aggressive case scenario.
  • USD 26.1 Billion in generics by 2016.
  • USD 200 Billion to be spent on infrastructure by 2024.
  • India’s filing of Drug Master File’s (DMF’s) with USFDA as of Dec 2013 is 3411, the highest filed by any country in the world.
  • Total exports of Drugs, Pharmaceuticals for 2013-14 at USD 15,095 million, recording a growth rate 2.5% over the corresponding period of previous years.


  • The National Pharmaceutical Pricing Policy, 2012 (NPPP-2012) has been notified on December 7, 2012.
  • The salient features of the NPPP-2O12 are as under:
    • The regulation of prices of drugs on the basis of the essentiality of drugs as specified under the National List of Essential Medicines (NLEM)- 2011.
    • The regulation of prices of drugs on the basis of regulating the prices of formulations only.
    • The regulation of prices of drugs on the basis of fixing the ceiling price of formulations through Market Based Pricing.
    • The provision of exemptions to drugs manufactured through indigenous R&D from price control for five years.
    • A Drug Price Control Order 2013 has been notified in May 2013 to implement the provisions of NPPP-2012.

Regulatory Environment 2

Companies Law 2

► The Indian Companies Law is an Act of the Parliament of India, enacted in 1956, which enables companies to be formed by registration, regulates and set out the responsibilities of companies, their directors and secretaries.

► Recently, new corporate law legislation viz. Companies Act 2013 has been enacted and few provisions has been notified, though other provisions are yet to be notified for its commencement – Has multiple implications for private & public companies operating in India

Stock Exchange Board of India (‘SEBI’) 3

► The SEBI is the regulator for the securities market in India. SEBI to protect interests of investors and to promote the development of securities market

Competition Commission of India (‘CCI’) 3

► Competition Commission of India is a body of the Government of India responsible for enforcing The Competition Act, 2002 throughout India and to prevent activities that have an adverse effect on competition in India. CCI to promote and sustain an enabling competition culture that would inspire businesses to be fair, competitive and innovative; enhance consumer welfare; and support economic growth

Form of entities (Pharma Companies)

Forms of comp

Watch this video :

1.      Douglas J. Pisano , David S. Mantus Laws of Drugs; FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics (1974 July 21) Edition 9, p. A1


3.      Jain Rajiv: Manual for Foreign Collaboration and Investment in India (1974 July 21; New Delhi India Investment Publication; Edition 5, 2003; p.1.228.


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2 responses on "Regulatory Organization & Sector Policy for Pharmaceuticals in India"

  1. Information is indeed important & useful for basic understanding….

  2. Wonderful web site. Plenty of useful info here. I am sending it to some friends ans also sharing in my social network. And certainly, thanks for your effort!

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