New Delhi: The Delhi high court on Friday sought response of the National Pharmaceutical Pricing Authority (NPPA) on a plea by an organization of drug manufacturers challenging the drug regulator’s 10 July notification that brought over 100 medicines under price control.
A bench of justice Vibhu Bakhru, however, refused to allow Organization of Pharmaceutical Producers of India’s (OPPI) interim plea seeking a stay or status quo order preventing the government from taking any further steps in pursuance of its notification.
“I am not inclined to stay it or pass any ad-interim order... Respondent (NPPA) to file counter (reply) in three weeks and rejoinder thereto in two weeks. List on 29 September," justice Bakhru said.
“Show that the power exercised by you (NPPA) is not unbridled as contended by them (OPPI)," the court said to the drug regulator which was represented by additional solicitor general (ASG) Sanjay Jain. The court also observed that paragraph 19 of the 2013 Drug Prices Control Order (DPCO) does not restrict price fixation to only essential drugs. Paragraph 19 of DPCO, 2013, authorizes NPPA in extraordinary circumstances, if it considers necessary so to do in public interest, to fix the ceiling price or retail price of any drug for such period as it deems fit.
During the proceedings, senior advocate Kapil Sibal, appearing for OPPI, argued that NPPA has cited extraordinary circumstances to fix caps on the prices of over 100 drugs which are non-scheduled formulations and lie outside the scope of National List of Essential Medicines (NLEM), but without saying what the extraordinary circumstances are.
Sibal also said that as per the government’s drug policy regime, prices of non-scheduled drugs are to be monitored, not fixed. “The government can interfere with the prices of non-scheduled drugs only if there is an increase of 10% more in their cost in a particular year," Sibal said. “They (government) can only decrease the price by 10% and that too for one year. That is the drug policy regime," he added.
He also said that the government can include these drugs in NLEM. ASG Jain, however, said the “paramount" reason behind the fixation of caps on the prices of these drugs was public interest and added that OPPI has not challenged the notification or paragraph 19 of DPCO. He also questioned the locus of the organization to file the present petition.
NPPA on 10 July had brought prices of over 100 non-scheduled drugs under price control as per paragraph 19 of DPCO. While bringing these drugs under price control, NPPA has noted that it is of the considered view that there exists huge inter-brand price differences in branded-generics/off patent drugs, which is indicative of a severe market failure.