The Supreme Court will soon hear a public interest litigation (PIL) challenging the National Pharmaceutical Pricing Authority (NPPA)'s September 22, 2104 circular under which the NPPA had withdrawn the Internal Guidelines dated 29.05.2014 on fixation/revision of prices of scheduled and non-scheduled formulations under paragraph 19 of DPCO, 2013.
It was by invoking this Guidelines that the national drug regulator had capped the prices of 108 non-scheduled formulation packs involving anti-diabetic and cardiovascular drugs under price control under Paragraph 19 of DPCO, 2013 on July 10 this year.
In the PIL, advocate Manohar Lal Sharma contended that the September 22 circular was against public interest as it would place drugs crucial to treating diabetes, blood pressure, cancer and rabies beyond the reach of common man.
The petitioner also demanded a CBI inquiry into what he claimed was the sudden turnaround in NPPA's action. A three-member bench, led by Chief Justice of India H L Dattu, agreed to hear the PIL soon.
In May 2014, the NPPA had issued a set of guidelines that empowered it to invoke its exceptional power under the DPCO to cap the prices of drugs in eight therapeutic categories if it found huge price differences between brands, and on July 10 it invoked this power to cap prices of 108 drug formulations in therapeutic categories such as diabetes and cardiovascular drugs.
Since then the industry associations have been on warpath and had challenged the order in the High Courts of Mumbai and Delhi.
The industry objected to NPPA's interference in prices of non-essential drugs. Following this, the ministry of chemicals and fertilisers had referred the issue to Solicitor General Ranjit Kumar, who had dubbed the NPPA action as an 'over-reach'. The ministry had then advised the NPPA to withdraw its controversial order dated 29.05.2014.
In his petition, Sharma claimed that there are around 6 crore blood pressure patients, 5.7 crore coronary heart disease patients, 4.1 crore diabetes patients, 25 lakh HIV/AIDS patients, 22 lakh TB patients and 11 lakh cancer patients in India. Any rise in prices of drugs for these diseases would pose a threat to their lives - a fundamental right guaranteed by the Constitution. He alleged that the NPPA's earlier order was withdrawn for 'vested interests' to permit the industry to reap 'windfall profits'.