Popular anti-diabetes drug teneligliptin, insulin glargine injection, Common antibiotics like meropenem, Cefuroxime have been included in the NLEM.
For the first time patented drugs like anti-TB drugs Bedaquiline and Delamanid, anti-HIV Dolutegravir and anti-hepatitis C Daclatasvir are also a part of the NLEM 2022 and their prices are set to get cheaper. Union health minister Mansukh Mandaviya released the revised NLEM today.
As many as 34 new drugs were added and 26 dropped from an updated list of essential medicines.
The listed medicines and devices cannot be sold above the prices fixed by the National Pharmaceutical Pricing Authority (NPPA). However, in a departure from the usual mechanism, the proposed list will be examined by a second committee before it is sent to the NPPA.
The new drugs on the list also include de-addiction formulation buprenorphine tablet, nicotine replacement therapy, cardiovascular tablet dabigatran and injection Tenecteplase, and an indigenous rotavirus vaccine.
Covid-19 drugs and vaccines were not included on the list, as these are under emergency use authorisation and more studies are required to understand the efficacy and drug profiles of these, said YK Gupta, vice chairperson of the Standing National Committee on Medicines that drafted the NLEM 2022.
An umbrella body of NGOs working to increase access and improve the rational use of essential medicines welcomed the inclusion of several branded medicines on NLEM 2022, but also said industry associations were successful to some degree in their efforts to keep such products out of the list.
“It is positive that the experts/ministry has explicitly clarified that patent status cannot be the basis to exclude a medicine from the NLEM and mentioned some of the patented drugs that have been brought into the NLEM for TB, Hep C etc.,” said Malini Aisola, co-convenor of the All India Drug Action Network.
In respect of cancer, it is disappointing that more of the highly priced, effective treatments for various cancers have not been included on the list, she said. “Trade margin rationalisation that the NPPA undertook a few years ago for about 42 cancer therapies is neither sufficient nor comprehensive in dealing with the steep costs of cancer medicines, and cannot be a replacement for direct price controls.”
“This NLEM includes four patented medicines for which companies have had robust access mechanism in place for India. OPPI is concerned with this inclusion of the four patented drugs and the signals it sends for value for innovation,” said Vivek Sehgal, director general, OPPI.
(With inputs from health)