NPPA fixes price of 272 new drugs in the first six months of 2022-23

New Delhi, November 1, 2022:

The drug price regulator has fixed prices of 272 drugs and reviewed the price of one combination drug during the first six months of the current financial year, besides extending its price control measures on the Covid-19 related products, according to the Department of Pharmaceuticals (DoP).

The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of 77 new drugs under the revised Schedule I of the National List of Essential Medicines (NLEM), 2015 during the month of September, 2022.

Including these, the cumulative retail price fixation during the six months from April 1, 2022 to September 30, 2022, was for 272 drugs, said the Department in a latest monthly review.

During the period, the Authority has also extended the price fixation on liquid medical oxygen (LMO) and oxygen inhalation (medicinal gas) in cylinder, and the ceiling prices fixed on heparin injection 1000 IU/ml and 5000 IU/ml, till December 31, 2022.

The Authority has also issued 12 preliminary notices to companies based on the monitoring and enforcement activities and an amount of Rs. 23.85 lakh was recovered towards overcharged amount during the month of September, said the Department.

According to a statement by BhagwanthKhuba, minister of state for chemicals and fertilisers, in August, 2022, NPPA has fixed the ceiling prices of 890 scheduled formulations of medicines under NLEM, 2015 till June 30, 2022. In addition, NPPA has fixed retail price of 2,023 new drugs under DPCO, 2013 till June. Besides, NPPA has also capped the trade margin of non-scheduled formulations of 42 anti-cancer medicines under ‘Trade Margin Rationalization’ approach as a pilot for proof of concept, wherein price of more than 500 brands of medicines were reduced up to 90%, he added.

During the six months, the NPPA has also revised the price of Pune-based Emcure Pharmaceuticals’ HIV drug combination darunavir 800 mg + ritonavir IP 100 mg tablet upwards, following a review order from the DoP.

NPPA has fixed the retail price of darunavir 800 mg + ritonavir IP 100 mg, as Rs. 197.55 per tablet, through an notification in November 8, 2019, while the same combination of Hetero Healthcare Ltd in November 2, 2018 was fixed at Rs. 212.91 per tablet based on the recommendation of the multidisciplinary committee (MDC) of experts.

The company approached the DoP following this and received a favourable order in June, 2021. DoP in its order observed that the NPPA could have used the retail price of Rs. 212.91 per tablet for Hetero Healthcare, while filing the retail price for Emcure Pharmaceuticals. After further communications from the DoP and deliberations, the NPPA notified the price of each darunavirethanolate equivalent to darunavir 800 mg and ritonavir IP 100 mg tablet manufactured by Hetero Labs Ltd and marketed by EmcurePharmaceuticals, will be Rs. 212.91. Pharmabiz