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DoP includes member of HTAIn in expert committee on pricing of drugs
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Gireesh Babu, New Delhi
January 02 , 2025
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Department of Pharmaceuticals (DoP) has added an expert representative from the Health Technology Assessment of India (HTAIn) under the Department of Health Research (DHR) as a member of the Committee of Experts it has constituted earlier for technical issues related to pricing of drugs.
The DoP, in a latest order partially modifying its order constituting the Committee of Experts in 2017, said that the Central government hereby includes an additional member on the Committee, for making recommendations related to pricing of new drugs.
The HTAIn, according to the DHR, is entrusted with the responsibility to analyse health technologies, such as medicines, devices and health programmes for its cost-effectiveness, clinical-effectiveness and equity issues by means of Health Technology Assessment (HTA), and in turn help in decision making for an efficient use of the limited health budget and provide people access to the quality health care reducing their out-of-pocket expenditures (OOPs) on health.
It has an economic assessment division which assesses cost effectiveness of medical devices, vaccines and drugs, diagnostics, intervention procedures and digital health technologies.
The DoP, on November 30, 2017, issued an order constituting the single multi-disciplinary Committee of Experts as instructed under the Drugs Prices Control Order (DPCO), 2013.
Under the DPCO, there are two different nomenclature - Standing Committee of Experts under Para 5(2)(I) and Para 15(1) of the DPCO and the Committee of Experts under Para 11(4) to discharge the functions under DPCO for consultation on all technical issues related to pricing, launch of new drugs along with other ancillary provisions where more clarity may be required, and opine on matters referred to it by the National Pharmaceutical Pricing Authority (NPPA) in discharge of its functions.
The Committee of Experts comprise of the member secretary, NPPA as the convener, a scientist or subject matter expert from the Central Drugs Standard Control Organisation (CDSCO) not below the rank of Deputy Drugs Controller General (India), a scientist or expert from the DHR or ICMR not below the rank of Deputy Secretary or equivalent, and a pharmacoeconomics expert from the National Institute of Pharmaceutical Education and Research (NIPER), to be nominated by the DoP, as its members.
The Committee is empowered to invite or co-opt any other specialist, such as in the field of medical devices, if it requires in any specific matter.
The Committee has the responsibility to deliberate and recommend its opinion on the claims of pharma companies about additional therapeutic features associated with any formulation including in terms of Para 11 (3) of DPCO, 2013 and recommending separate ceiling price of scheduled formulations or retail price of a new drug with specified therapeutic rationale, considering the type of packaging or pack size or dosage compliance or content in the pack conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the relevant rules.
It also has the responsibility to deliberate, interpret and recommend its opinion on the claims of pharma companies about additional pharmacoeconomics features associated with any formulation/API including in terms of Para 15 (l) of DPCO, 2013, and to deliberate, interpret and recommend its opinion on the technical related issues whether the drug is scheduled or non-scheduled on the basis of ingredients used in the formulation.
The Committee also has the powers to deliberate, interpret and recommend its opinion on the claims of pharma companies about novelty associated with indigenous R&D content passed through the development process of relevant API or formulation and recommend exemption from the DPCO provisions for a period of five years.
The Order appointing the Committee of Experts was amended on January 10, 2018, to appoint the Advisor (Cost), NPPA as the convener of the Committee, instead of the member secretary of NPPA.
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