India’s updated list of essential medicines will consist of a wider basket of products, ranging from medicines and medical devices to consumables and hygiene products, The Indian Express has learnt. However, not all of these products may come under price control, according to people close to the development. While a national standing committee set up last year to scrutinise and update the 2015 National List of Essential Medicines (NLEM) is yet to finalise products forming the basis for a new NLEM, it has set up sub-committees to look into different categories that will be in focus, as per sources. The Standing National Committee on Medicines (SNCM) on Thursday during consultations with pharmaceutical companies, lobby groups and patient bodies said its mandate would not just limit its work to determining medicines crucial for the Indian population, but that it will be looking at medical devices, medical disposables and consumables as well as hygiene and “other” healthcare products. It has envisaged a “country specific and dynamic” process of reviewing the products in the new list. According to a person directly aware of the development, this means that the committees will not only help finalise the list by meeting once every six months, but will also meet afterwards “as needed” in case the need is felt to add more products. The committees will be choosing products on the basis of the prevalence of the disease they treat and with due regard to evidence of their safety and effectiveness as well as their comparative cost-effectiveness, according to a presentation made during the meeting on Thursday, parts of which The Indian Express has viewed. These products are intended to be available “at all times”, in “adequate” amounts, in the “appropriate” dosages, with “assured quality” and “at a price the individual and the community can afford”, according to the presentation. At the same time, the committee is learnt to have told stakeholders that price control will not be a primary focus for bringing products into the list. “NLEM is one of the ways in which the government chooses products for price control, but there are other mechanisms as well. The role of the standing committee is to focus on how essential the products are for the country, and it will include them in an evidence-based manner,” said a source. In addition to the four sub-committees that will be reviewing these products, there will also be separate committees focussing on cancer and cardiovascular drugs as well as one looking at including medicines to tackle India’s growing antimicrobial resistance (AMR) problem. Another person present at the meeting said that it was indicated that the Department of Pharmaceuticals (DoP) and the Standing Committee on Affordable Medicines and Health Products (SCAMHP), set up in January this year to advise the National Pharmaceutical Pricing Authority (NPPA) on medicine prices, may focus more on the products from the new NLEM that would come under price control. Earlier, medicines included in the NLEM would be notified by DoP under Schedule 1 of the Drugs (Prices Control) Order, 2013. Following this, NPPA would notify the maximum price at which companies can sell them in India. The committees will be carrying out “regular” consultations with all stakeholders, said sources. The NLEM 2015 has over 350 medicines, including medical devices — stents, IUDs and condoms.
