Healthcare Global Enterprises Ltd's appeal challenging the 2019 order by the Ministry of Chemicals and Fertilisers, which imposed a 30% cap on trade margin of 42 anti-cancer drugs, was dismissed by a division bench of Chief Justice Prasanna B Varale and Justice M G S Kamal on Monday. The appeal had contested a single judge bench order from November 30, 2022, which had upheld the Ministry's order.
The court, with reasons to be recorded separately, dismissed the appeal challenging the 2019 order that imposed a 30% cap on the trade margin of 42 anti-cancer drugs. Last year, Justice M Nagaprasanna of a single judge bench had dismissed the petition and stated that cancer drugs need to be affordable as cancer patients in India incur heavy expenditure. He emphasized the need for such policies, so that treatment can be accessible to everyone, regardless of their financial status, and that high drug prices should not result in the unaffordability of treatment, which can cause the poor or middle class, a majority of India's population, to succumb to the disease.
Healthcare Global Enterprises Ltd., which claimed to be India's largest provider of cancer care with 20 comprehensive care centers across the nation, had filed the petition. They had argued that the National Pharmaceuticals Pricing Authority (NPPA), which issued the notification, did not have the authority under the Price Control Order to fix the ceiling or retail price of non-scheduled formulations, which included anti-cancer drugs. The petitioner contended that non-scheduled formulations should be determined by the market force and should not be subject to any regulation.
Healthcare Global Enterprises Ltd. had argued that the 30% cap imposed on the trade margin of anti-cancer drugs was arbitrary and imposed an unreasonable restriction on their right to trade under Article 19(1)(g) of the Constitution. They claimed that there was no extraordinary circumstance for the fixing of the ceiling or retail price of any drug.
However, the court referred to the National Pharmaceuticals Pricing Policy, 2012, which aims to regulate drug prices based on the essentiality of such drugs rather than market share or economic criteria. The court noted that the Drugs (Prices Control) Order 2013 was notified by the Government of India, which superseded the Drugs (Prices Control) Order, 1995, and empowered the government to monitor the maximum retail prices of all drugs, including non-scheduled formulations, under Clause 20.
The court emphasized that the fixation of the ceiling price of a drug is a power available to the government under Clause 20, notwithstanding anything contained in the Prices Control Order. Schedule-I of the order enlists the drugs that would come under the ambit of such control, including non-scheduled formulations. The court also noted that Clause 20 permits the government to monitor non-scheduled formulations to ensure that no manufacturer increases the maximum retail price of a drug more than what is found in Clause 20.
Case Title: HEALTHCARE GLOBAL ENTERPRISES LIMITED v. UNION OF INDIA & Others
Case No: WRIT Appeal No: 83/2023
Date of Order: 27-03-2023
Appearance: Advocate Deepak Bhaskar for appellant.
CGC Kumar M N for respondents
TAGS: ANTI-CANCER DRUGS KARNATAKA HIGH COURT CANCER PHARMACEUTICALS
