In a statement, the government said the internal guidelines issued by NPPA on May 29, 2014 and its orders on July 10 to fix prices of 108 formulation packs of anti-diabetic and cardiovascular drugs have been challenged in Bombay and Delhi High Court.
Government today said it has not withdrawn powers delegated to NPPA but only internal guidelines issued by the drug price regulator to cap prices of non-scheduled drugs have been rolled back. In a statement, the government said the internal guidelines issued by NPPA on May 29, 2014 and its orders on July 10 to fix prices of 108 formulation packs of anti-diabetic and cardiovascular drugs have been challenged in Bombay and Delhi High Court.
"The Union of India and NPPA which have been made respondents, after careful consideration in consultation with the (ministry of) Law and Justice had decided to convey to the Hon'ble Courts that the guidelines dated 29.05.2014 are to be withdrawn," the statement said.
It further said: "The government has neither withdrawn the powers delegated to NPPA on 30.05.2013 nor NPPA has been directed to withdraw the orders dated 10.07.2014." On May 29, the National Pharmaceutical Pricing Authority (NPPA) had issued internal guidelines, which sought to fix prices of non-scheduled drugs in various therapeutic areas, including cancer, HIV/AIDS and diabetes -- the MRP for which exceeds 25 per cent of simple average of medicines in those groups.
The guidelines also sought to control the launch price of non-scheduled formulations by capping the price of any new brand at par with the price of the highest brand in the segment. It had also stated that in cases of shortages of scheduled and non-scheduled formulations, prices may be examined on case to case basis for price fixation or revision under para 19 of DPCO 2013.
These initiatives were taken up by the NPPA drawing on the special provision provided by the paragraph 19 of Drugs Price Control Order, 2013 (DPCO, 2013) that allows it to fix ceiling price of a drug under extra-ordinary circumstances, "if it considers necessary so to do in public interest". The government statement said consequent to notification of National Pharmaceuticals Pricing Policy-2012 (NPPP-2012) on December 7, 2012 and notification of Drugs Price Control Order, 2013 (DPCO, 2013), the powers of the Government were delegated to NPPA on May 30, 2013.
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