New Delhi: The Department of Pharmaceuticals (DoP) has once again expanded the list of special invitees for its Committee for reforms in the pricing framework for drugs and medical devices, formed in March this year to include representatives from the largest pharmacy trade organisation, healthcare service providers’ organisation and the doctor’s association along with various patient advocacy groups.
This is the second time the list is broadened, after it expanded the list of special invitees in April, to include all major pharma manufacturing industry organisations in line with the request of the representatives from the organisations.
It has now issued an order to add seven more members to the list of special invitees with the existing 12 invitees. With this, there would be 19 special invitees with representation from 19 organisations.
The Department said that representatives from All India Drug Action Network (AIDAN), Healthcare Foundation of India (NAT Health), Patient Safety and Access Initiative of India Foundation, Indian Medical Association (IMA), All Indian Organisation of Chemists and Druggists Association (AIOCD), Laghu Udhyog Bharti, and Medecines Sans Frontieres (MSF) India have been included in the committee as invites.
The terms of reference of the Committee shall remain the same as mentioned in the Office Memorandum issued on March 12, 2024, it added.
It may be noted that the initial notification on March 12, had a provision to have two special invitees from the industry, one each from the Indian Pharmaceutical Alliance (IP Alliance) and Indian Drugs Manufacturers’ Association (IDMA). However, the number of special invitees was broadened to 12, through an order on April 22, 2024.
The 12 members added through the order in April include the director general of Organisation of Pharmaceutical Producers of India (OPPI), managing director, US-India Strategic Partnership Forum (USISPF), chairman of Medical Technology Association of India (MTaI), director general, Confederation of Indian Industry (CII), director, US India Business Council (USIBC), secretary general, Federation of Indian Chambers of Commerce and Industry (FICCI), Forum Coordinator, Association of Indian Medical Device Industry (AiMeD), executive director of Federation of Pharma Entrepreneurs (FOPE), representatives of Advamed, Association of Diagnostic Manufacturers of India (ADMI), Bulk Drugs Manufacturers Association of India (BDMAI), and Associated Chambers of Commerce & Industry of India (Assocham).
The committee, constituted to prepare a draft Drugs and Medical Devices (Control) Order, was expected to submit its report in three months.
The Committee has three core members headed by Arunish Chawla, secretary, Department of Pharmaceuticals (DoP), with Kamlesh Kumar Pant, chairman of National Pharmaceutical Pricing Authority (NPPA) and Awadhesh Kumar Choudhary, senior economic advisor, DoP as members.
The committee shall look into various aspects including the institutional reforms required for the NPPA, how to balance price and availability of essential medicines, while providing incentives to the industry to sustain growth and exports, how to design a price moderation framework for medical devices, while providing incentives to the industry to sustain growth and minimise imports, and how to design a price moderation framework for emerging and precision therapies to facilitate their timely reach to the needy patients.
It is expected to come out with a draft Drugs and Medical Devices (Control) Order to achieve these objectives. It may be noted that the drug price order that currently prevails is named as Drugs (Prices Control) Order, 2013.
According to NPPA, the price control over drugs was first introduced in the country in 1962 under the Defence of India Act, 1915 with the introduction of Drugs (Display of Prices) Order, 1962, as there was a substantial increase in prices of medicines owing to the Indo-China war. The Order was updated through the Drugs (Control of Prices) Order, 1963.
These orders led to freezing of drug prices with effect from the beginning of 1963 and a series of price control orders were notified based on different principles.
Various committees constituted by the governments, including the Kelkar Committee in 1984, the Pharmaceutical Research and Development Committee (PRDC) and the Drug Price Control Review Committee (DPCRC), in 1999, Pronab Sen Committee set up in 2004, Sandhu Committee constituted in August, 2004, among others had their impact on the country’s drug price policy and control orders from time to time.
The Kelkar Committee Report recommended exclusion of a number of drugs from the purview of price control, with various suggestions for determining the criteria for inclusion and exclusion and recognising the need for liberalising the profitability curbs. The Pronab Sen Committee report recommended price ceiling of 314 medicines that fall under essential drugs and said that the price regulation should be on the basis of essentiality of the drug and it should be applied only on formulations and not to upstream products, such as bulk drugs. It recommended that the ceiling price of essential drugs should normally not be based on cost of production but on easily monitorable market based benchmarks.
The Sandhu Committee looked into the span of price control including the trade margin in the light of National Common Minimum Programme and the observations from the Supreme Court on a matter prior to the formation of the Committee. It suggested a total trade margin of 24 per cent for scheduled drugs including 8 per cent margin for wholesalers and 16 per cent for retailers, 30 per cent total margin for branded category non-scheduled drugs and 50 per cent for generic non-scheduled drugs.
The National Pharmaceutical Pricing Policy (NPPP), notified on December 7, 2012, formulated with an objective to put in place a regulatory framework for pricing of drugs made a shift from earlier ‘cost based’ pricing under the Drug Policy, 1994 to ‘market based’ pricing. Following this, the government notified the DPCO, 2013.
