India: Department Of Pharmaceuticals (DoP) Issues Order Regarding Constitution Of A Committee Of Experts To Discharge The Functions Under DPCO, 2013

The Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Government of India has issued an office order regarding constitution of a committee of experts for consultation on technical issues related to pharmaceuticals pricing, launch of new drugs along with other ancillary provisions where more clarity may be required1.

In its order the DoP indicated that 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 nomenclatures 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, and opine on matters referred to it by the National Pharmaceutical Pricing Authority (NPPA) in discharge of its functions.

The order also states that the Committee of Experts shall comprise of the following members:

  • Member Secretary, National Pharmaceutical Pricing Authority (NPPA) - Convener;
  • Representative (Scientist/Expert) from Central Drugs Standard Control Organization (CDSCO) (Subject matter expert) not below the rank of Deputy DCGI - Member;
  • 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 - Member;
  • Representative (Pharmacoeconomics expert) from NIPER (to be nominated by DoP) - Member;

The above said Committee would be empowered to invite or co-opt any other specialist (example a Medical Devices expert) 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.

The purpose of the Committee shall be as under:

  • To deliberate and recommend its opinion on the claims of Pharma companies about additional therapeutic features associated with any formulation including in terms of Paragraph 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.
  • 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 Paragraph 15 (1) of DPCO, 2013.
  • To deliberate, interpret and recommend its opinion on the technical 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 Paragraph 32 of DPCO, 2013 for a period of five years.
  • To discuss any other issue referred to the Committee of Experts concerning technical matters involved in disposing of any issue raised by any stakeholder.

In this regard, NPPA shall decide and refer the relevant issues within 4 weeks of receiving the applications, to the Committee for its opinion. Thereafter, the Committee shall submit its report with its findings and opinion in each case within a period of 4 weeks.

Further, the recommendations of this committee shall 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.

Note - The order was issued by Department of Pharmaceuticals with the approval of Hon'ble Minister, Ministry of Chemicals and Fertilizers, Government of India.

Conclusion:

The Department of Pharmaceuticals of Government of India has established this high-level, multidisciplinary committeeofexpertstoproviderecommendationsconcerningapprovalandpricingofnewdrugsorformulations. The decision to establish this committee came from the significant experience gained since implementation of ices Control Order, 2013.

Footnote

1. http://pharmaceuticals.gov.in/sites/default/files/Final%20Expert%20Committee%20by%20DoP.pdf

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