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DoP to constitute expert committee for consultation on all technical issues related to pricing and launch of new drugs

Ramesh Shankar, Mumbai
Monday, December 4, 2017, 15:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) will soon constitute a single multi-disciplinary expert committee for consultation on all technical issues related to pricing and launch of new drugs and give opinion on matters referred to it by the national drug price regulator National Pharmaceutical Pricing Authority (NPPA).

The terms of reference of the committee will be 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 namely liquid, gaseous or any other form, in the unit dosage as the case may be, conforming to Indian Pharmacopeia or other standards as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation.

Other terms of reference are 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 (1) of DPCO, 2013; 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; 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/formulation; and recommend exemption from the application of provisions of para 32 of DPCO, 2013 for a period of five years; and to  discuss any other issue referred to the Committee of Experts concerning technical matters involved in disposing of any issue raised by any stakeholder.

The NPPA will decide and refer the relevant issues within 4 weeks of receiving the applications, to the committee for its opinion.  The committee will submit its report with its findings and opinion in each case within a period of 4 weeks and the recommendations of this committee will be considered by the NPPA which shall pass a reasoned order within 4 weeks from receiving the recommendations of the committee, deciding the issue(s) in hand finally.

“In view of the experience gained from implementation of Drugs (Prices Control) Order, 2013 (DPCO, 2013), it has been decided to constitute a single multi-disciplinary "Committee of Experts" by the Government as envisaged by two different nomenclature i.e. Standing Committee of Experts under para 5(2) (i) & para 15(1) and the Committee of Experts under para 11 ( 4) to discharge the functions under DPCO, 2103 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 Do P said.

Member Secretary, NPPA will be the convener of this committee. Other members of the committee included representative (Scientist/Expert) from Central Drugs Standard Control Organization (CDSCO) (Subject matter expert) not below the rank of Dy. DCGI; representative (Scientist/Expert) from the Department of Health Research (DHR)/Indian Council of Medical Research (ICMR) (Subject matter expert) not below the rank of Deputy Secretary or equivalent; and representative (Pharmacoeconomics expert) from NIPER (to be nominated by DoP).

The above said Committee would be empowered to invite or co-opt any other specialist (like Medical Devices) depending on exigencies of the circumstances requiring resolution of any specific matter arising out of implementation of various provisions of DPCO, 2013, as and when it may be required.

 

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