The government has decided to increase the basket of medicines and medical products—such as devices, disposables and hygiene items—that it says should be available within the health system in adequate numbers and assured quality. The newly constituted committee on National List of Essential Medicines (NLEM) that met on 18 September decided that sub-committees will be formed to categorize medicines, medical devices, disposables, and health and hygiene products according to how essential they are for healthcare. With this, the government departs from the existing mechanism by delinking essential medicines from price control. Earlier drugs declared essential would automatically fall into price control. However, federal think tank NITI Aayog in April this year suggested that two committees be formed—one for shortlisting essential medicines and another for bringing medicines under price control. The committee on affordable medicines will be under the vice-chairman of NITI Aayog with secretaries from both ministry of health and department of pharmaceuticals who are being mandated to select medicines and medical devices to be brought under price control.
The committee on essential medicines was formed under the secretary department of health research and director-general, Indian Council of Medical Research, Balram Bhargava in July. “In their first meeting that held in September, it has been decided that separate sub committees will be formed. There will be sub committees to segregate medicines, medical devices, disposables and health and hygiene products that should be declared essential,” said a senior official in the health ministry. The NLEM is based on the country’s disease burden and priority health concerns. The committee will also prepare detailed guidelines and procedures for revision of NLEM and suggest changes to the list. The increased basket to be prepared will help guide effective treatment of priority diseases and promote rational use of the products. The NLEM list is reviewed every three years to include or exclude drugs. NITI Aayog had earlier sought the views of experts on whether the NLEM should be linked from the Drug Price Control Order (DPCO), which drugs to bring under price control and how price caps should be determined.
Currently, the health ministry prepares a list of drugs eligible for price regulation. Then the department of pharmaceuticals, which comes under the ministry of chemicals and fertilizers, incorporates them into Schedule 1 of DPCO. Following this, the National Pharmaceutical Pricing Authority (NPPA) fixes the prices of drugs in this schedule. “As per the existing procedure, the list once adopted by the government, becomes the part of the Drug Price Control Order and hence the price is regulated,” said another official. Medicines and devices listed in NLEM must be sold at the price fixed by NPPA, while those in the non-scheduled list are allowed a maximum annual price hike of 10 percent. The matter regarding NLEM and amendments to DPCO has been under discussion at NITI Aayog, which had met pharma lobby groups early in January at the behest of the PMO after companies expressed dissatisfaction over the way NPPA set price caps. Pharma experts were asked to propose changes in the manner the government identifies medicines that should be brought under price control and suggest the best approach to make timely additions and deletions in NLEM. – Livemint