New Delhi, Sept 13: As many as 34 new drugs were added and 26 dropped from an updated list of essential medicines that will lead to prices being fixed, said the government on Tuesday.
The National List of Essential Medicines (NLEM 2022) has 384 drugs, up from 376 covered in 2015. “Drafting this list is a lengthy process, and around 350 experts from across India have held over 140 consultation meetings to draft the NLEM 2022,” said Union Health Minister Mansukh Mandaviya.
With the release of this NLEM, several essential medicines are set to get cheaper in India. These include anti-diabetic drugs like insulin glargine, anti-tuberculosis drugs like delamanid, and antiparasite like ivermectin.
Most drugs in NLEM 2022—it will guide the National Pharmaceutical Pricing Authority (NPPA) to cap medicine prices—are anti-infectives (antibiotics, antifungal etc), medicines to treat diabetes, HIV, TB, contraceptives, hormonal medicines, some blood clotting disorders related medications, and anesthetics. Common antibiotics like meropenem, Cefuroxime, popular anti-diabetic drugs like insulin Glargine, and teneligliptin are part of the NLEM 2022.
The medicines listed in the NLEM are sold below a price ceiling fixed by the National Pharmaceutical Pricing Authority (NPPA). Price rise for scheduled drugs is linked to the wholesale price index-based inflation. For non-scheduled drugs, companies can hike prices by up to 10 per cent every year. Scheduled drugs roughly constitute 17-18 per cent of the estimated Rs 1.6-trillion domestic pharma market. Around 376 drugs are under price control.
Covid-19 medications and vaccines are not made a part of NLEM 2022 as these are under emergency use authorization (EUA) and more studies are required to understand the efficacy and drug profiles of these, said Y K Gupta, a pharmacologist, and vice chairperson of the Standing National Committee on Medicines (SNCM), which drafted NLEM 2022.
Gupta said that a vaccine included in the National Immunisation Programme (NIP) automatically becomes a part of the NLEM. The rotavirus vaccine became a part of the NIP in 2016 and has now been included in the NLEM.
As many as 384 drugs in NLEM 2022 would roughly cover around 1000 formulations. The 376 drugs in NLEM 2015 covered roughly 800 formulations. The scheduled drugs that were part of the NLEM 2015, roughly contributed 17-18 per cent of the Rs 1.6-1.7 trillion domestic pharma market.
Medicines that feature in the NLEM are called scheduled drugs. The NPPA fixes the prices of these drugs based on the wholesale price index inflation. For all other drugs, the companies are allowed to take a maximum hike of up to 10 per cent annually.
Scheduled drugs (NLEM 2015) roughly constitute 17-18 percent of the estimated Rs 1.6-trillion domestic pharma market.
Union Health secretary, Rajesh Bhushan said that the NLEM is prepared on safety, efficacy and cost (affordability). “It includes only those drugs that are approved by the Indian regulator, and also this list is drafted keeping in mind the disease burden and current treatment line in the country,” he said.
