New Delhi: At a stakeholder consultation meeting held by the Indian Council of Medical Research (ICMR) Monday, Indian drugmakers requested the Narendra Modi government to defer the process to refresh the list of essential medicines to next year citing the Covid-19 crisis, ThePrint has learnt.
The ICMR is working on a plan to revise the National List of Essential Medicines (NLEM) with special focus on adding drugs used to treat cancer, diabetes and thyroid. The list, which was notified in 2015 and implemented in 2016, includes all the drugs that fall directly under the government’s price regulation mechanism.
During the virtual meet, the drugmakers made the request citing their struggles fixing the supply chain and efforts to avoid drug shortages due to Covid outbreak.
“The different lobbies and pharma company representatives have highlighted that it’s not an appropriate time to start an exhausting exercise to refresh the NLEM. They want us to postpone the process till the second quarter of 2021,” a senior government official told ThePrint.
“We will consider the industry’s point in our further, internal discussions. We are working for ‘public interest’ and we need to weigh in all factors before postponing the revision,” said the official, who did not wish to be named.
Lobbies representing foreign-based pharma giants also requested top government officials to “not include the patented drugs under the purview of price control and only include specific strengths of the drugs under the list”.
Apart from Indian lobbies such as the Indian Drug Manufacturers’ Association (IDMA) and the Indian Pharmaceutical Alliances, several lobbies representing foreign pharma companies also attended the meet. These included American business advocacy organisation, US-India Business Council (USIBC), US-India Strategic Partnership Forum (USISPF) and Organisation of Pharmaceutical Producers of India (OPPI).
Y.K. Gupta, vice-chairperson of the Standing National Committee on Medicines (SNCM) — a panel constituted by the Ministry of Health and Family Welfare to revise NLEM — led the meet. Gupta is a former professor and head of department of pharmacology, All India Institute of Medical Sciences.
Dr Vijay Kumar, head, basic medical sciences division of ICMR, A.K. Pradhan, deputy drug controller from Central Drugs Standard Control Organization, and Dr Nilima Kshirsagar, national chair clinical pharmacology, ICMR, also attended the meeting.
‘Essentiality, not turnover, should be criterion’
Apart from seeking postponement of the NLEM refresh process, the industry also requested the government panel to consider “essentiality” of the drug as the only criterion for inclusion under the NLEM and not the “turnover” of the drug.
“We have also requested the government to keep patented drugs out of the purview of NLEM. Moreover, only specific strength of the drugs should be included in the list and not all the varieties and dosage forms,” said an industry representative who was part of the meeting.
“The industry has also highlighted that if a drug for a particular disease is already added in NLEM, then more drugs for the same disease should not be added.”
What is NLEM, and why its revision is significant
The NLEM is regulated by the Department of Pharmaceuticals arm, National Pharmaceuticals Pricing Authority, which is the country’s drug price and availability watchdog.
The list includes all the formulations, which fall directly under the government’s price regulation mechanism. The manufacturer cannot randomly increase prices without prior approvals.
Using Para 19 of the Drug Price Control Order, 2013 — the law that governs the pricing of medicines in India — the central government expands the price control mechanism.
The rates of drugs included under the NLEM are capped on the basis of their ceiling prices, which are calculated by taking the simple average of all drugs falling under the same category, but with market share of at least 1 per cent.
For other drugs — which are not included in the NLEM — the manufacturers can raise the prices by up to 10 per cent every year.
In 2019, in a written reply to a question in Parliament on the benefits received by citizens due to a reduction in the price of essential medicines, Minister for Chemicals and Fertilisers D.V. Sadananda Gowda had said “a saving of Rs 2,644 crore was made under NLEM 2015 from March 2016 till date”.