Govt initiates new process to identify essential medicines

Highlights: - Committee to meet stakeholders on July 25 to shortlist drugs that should be available in assured quality - Stakeholders have been asked for their feedback on cardiology and cancer drugs  -------------------------------------------------

The prices of some drugs used for treating cancer, cardiac diseases and diabetes are likely to be cut as the government initiates a new process to identify essential medicines and bring some of them under price control.

A newly-constituted committee on the National List of Essential Medicines (NLEM) will meet stakeholders on Thursday to shortlist drugs that should be available in adequate numbers and assured quality, according to a senior government official.

The NLEM committee, headed by Balram Bhargava, secretary, Department of Health Research and Director-General of the Indian Council of Medical Research, will decide on essential medicines and send the list to a second committee, comprising Rajiv Kumar, Vice-Chairman of NITI Aayog, Preeti Sudan, Secretary of the Health Ministry, and P Raghavendra Rao, Secretary of the Department of Pharmaceuticals, for deciding which ones are to be brought under price control.

This is a departure from the existing mechanism in which all essential medicines were brought under price control. Under the previous mechanism, the health ministry prepared a list of drugs eligible for price regulation, following which the department of pharmaceuticals, which comes under the ministry of chemicals and fertilizers, incorporated them into schedule 1 of DPCO (drug price control order). Following this, the National Pharmaceutical Pricing Authority (NPPA) fixed the prices of drugs in this schedule. “The list, once adopted by the government, would become part of the drug price control order, and hence, the price is regulated," said another government 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.

In its first meeting to be held on July 25, stakeholders, including representatives of drug makers, pharma lobby groups and non-profits, have been asked for their feedback on cancer drugs, cardiology drugs, penicillin preparations, information on anti-microbial resistance and a review of NLEM 2015. The NLEM list is reviewed every three years to include or exclude drugs.

The changes to the list of essential medicines, according to industry experts, is expected to be made on the lines of the World Health Organisation’s essential list published earlier this month. “The committee will look into the drugs with the potential to improve outcomes with advanced therapies for cancer, cardiac ailments and diabetes. It will also look into antibiotics drugs and its resistance," said a senior member of a pharma lobby group on condition of anonymity.

Malini Aisola, co-convenor of the All India Drug Action Network, a not-for-profit, is unhappy with how the meeting has been arranged. “The agenda is set up in a way that pharma companies and their associations are dominating the sessions. Their views are clearly being given preference whereas it is important that the committee consider views from public health groups," she said.

The updated essential medicines list of WHO incorporates five new cancer therapies and two immunotherapies for advanced melanoma.

The medicines list also tackles strokes with the inclusion of new oral anticoagulants, biologics for chronic illnesses including rheumatoid arthritis and inflammatory bowel disease, and heat-stable carbetocin for preventing postpartum haemorrhage.

On diagnostics, the WHO makes tackling cancer a priority with an emphasis on tests to ensure timely diagnosis. It includes tests for 12 cancers in the list as well as anatomical pathology to be made available in specialised labs.