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DoP panel to review scope of DPCO, 2013 and to suggest ways for strengthening regulatory provisions
Ramesh Shankar, Mumbai | Tuesday, April 4, 2017, 08:00 Hrs  [IST]

The Department of Pharmaceuticals (DoP) has constituted a high level committee under Joint Secretary (Policy), DoP, to review the scope of the Drugs (Price Control) Order, 2013 (DPCO, 2013), and to suggest ways for strengthening the regulatory provisions of the order for ensuring enhanced accessibility of drugs to the poor patients in the country.
The panel has also been asked to recommend measures to be taken for making pricing policy more in favour of poor patient's affordable medicare and health security.

Joint Secretary (NIPER & PSU), DoP; Joint Secretary, Ministry of Health & Family Welfare; Joint Secretary & Member Secretary, NPPA; Drugs Controller General of India (DCGI); are Executive Director, National Health System Resource Centre (NHSRC) are the other members of the committee which has been asked to submit its report within six weeks from the date of its constitution. Director (Policy), DoP, will be the convener of the committee.

The committee has been asked to suggest ways for making the existing mechanisms for collection of market-based data on prices of medicines more robust and streamlined and for strengthening the existing pharmaceutical database management system. It has been asked to make recommendations on procedural improvements and process re-engineering in NPPA to ensure better and quicker implementation of DPCO and bring greater transparency so as to reduce litigations and review petitions.

 Besides, the panel  has been asked to recommend detailed Standard Operating Protocol (SOPs) for identified regulatory functions such as pricing of medicines, monitoring and enforcement activities, action against pharmaceutical companies in overpricing cases etc. Further, it has been asked to suggest ways to make DPCO, 2013 more comprehensive in light of past experience of implementing DPCO. The panel has also been asked to consult other government agencies, officials or representatives of industry or civil society in the interest of a more effective DPCO.

Earlier in 2012, the government had notified the National Pharmaceutical Pricing Policy, 2012 with the objective to put in place a regulatory framework for pricing of drugs so as to ensure availability of "essential medicines" at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of pharma industry, thereby meeting the goals of employment and shared economic well being for all.

Subsequently, the DPCO, 2013 was notified by the government on 15.05.2013. The DPC0-2013 inter-alia provides that ceiling price(s) for the medicine(s) added in the First Schedule (of DPC0-2013) shall be fixed in accordance with the DPC0-2013. NPPA has fixed the ceiling prices of 835 Drugs (upto 24.03.2017) under these provisions.

However, the DoP received various requests and representations including from the NPPA, the pharma industry associations and other stake holders suggesting improvements in the provisions of DPC0-2013 based on the experience gained during its implementation.

In the light of these representations and to further improve the availability, affordability and accessibility of drugs for the domestic patients, the DoP decided to constitute a high level panel.

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