| The Department of Pharmaceuticals, to further ease the implementation of DPCO 2013, has decided to set up a high-level single multi-disciplinary expert committee consisting of experts from National Pharmaceutical Pricing Authority, Central Drugs Standard Control Organisation, Department of Health Research and the Indian Council of Medical Research. The panel will assist the national drug price regulator NPPA on matters of pricing and launch of new drugs. It will 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 NPPA. The committee has been mandated to express 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. The panel will recommend 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. The panel will be discharging its duties conforming to Indian Pharmacopeia or other standards as specified in the D&C Act, 1940 (23 of 1940) and the rules made thereunder for the same formulation. More importantly, the panel has been entrusted 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. Further it will 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 panel will also 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. It will also recommend exemption from the application of provisions of para 32 of DPCO 2013 for a period of five years. 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 4 weeks and its recommendations will be considered by the NPPA which shall pass a reasoned order within 4 weeks from receiving the recommendations of the committee, deciding the issues in hand finally. There are two existing expert committees - a standing committee whose role is restricted to new drug launch and take decisions on how to implement price control; and another committee of experts that evaluates issues related to packaging and innovation. The new multi-disciplinary committee will supersede the existing ones and the new committee will deal with all of these issues and give its recommendations in a time-bound manner. Considering the fact that, of late, there has been a steady increase in the number of disputes between the NPPA and the pharma companies on issues ranging from launch of new drugs to fixing of ceiling prices, the constitution of a single multi-disciplinary expert committee is a decision in right direction. Even though the recommendations of the committee are not binding, it will go a long way in reducing the arbitration between the price regulator and the pharma companies in the times to come. (Pharmabiz.com) |
