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Vol. 9 (2013)

Is The National Pharmaceutical Policy, 2012 Really Cheering The Pharma?

Dipika Jain

The National Pharmaceutical Policy was approved by the Cabinet and notified in 2012. Based on this policy, a new Drugs Price Control Order was notified in May, 2013. As a result, several drugs will come within the ambit of price control under the National list of Essential Medicines (NLEM). The primary purpose of NLEM is to facilitate the rational use of medicines which will allow for cost effective, safe and drugs with efficacy. This paper critically evaluates the provision on exclusion of patented drugs in the recent National Pharmaceutical Policy, 2012 from the Drug Pricing Policy for five years. The policy states “Drugs patented under the Indian Patents Act, 1970 and which have been made as a result of indigenous products or process have been exempted from price control for a period of five years.” Further, a formulation involving a new delivery system developed through indigenous R&D would be eligible for exemption from price control for a period of five years from the date of its market approval in India. While this exclusion may have been designed keeping the opportunity for innovation for pharmaceutical companies, however, given the critical situation of HIV/AIDSs medication, cancer drugs, tuberculosis etc., it is pertinent to have these drugs under price control well before the prescribed period of five years. This paper argues that this provision of the NLEM, 2012 contravenes the main objective of this policy and in turn violates the Constitutional right to life and health of millions of people who need these patented lifesaving drugs, especially the people living with HIV/AIDS (PHLAs).


Dipika Jain is Assistant Professor of Law and Executive Director of the Centre for Health Law, Ethics and Technology at the Jindal Global Law School (Delhi, India).

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