Govt plans to review existing drug price control measures

New Delhi : The government plans to review the existing drug price control measures to make medicines more affordable, while also undertaking "re-engineering" of price regulator NPPA to bring greater transparency amid allegations from the industry over arbitrary implementation of policy.

It has constituted a panel comprising joint secretaries from department of pharmaceuticals (DoP), health and family welfare ministry, NPPA member secretary and Drugs Controller General of India (DGCI), among others, to recommend steps to make medicines more affordable.

The terms of reference of the group, which held its first meeting today, include measures to be taken for making policy more in favour of poor patients, affordable medicare and health security, DoP said in a notification.

One of the key points to consider for the panel, of which DoP Director (Policy) will be the convenor, is "procedural improvement and process re-engineering in NPPA to ensure better and quicker implementation of government policy (DPCO) and bring greater transparency so as to reduce litigations and review petitions".

The panel will recommend detailed standard operating protocols for identified regulatory functions, such as pricing of medicines, monitoring and enforcement activities, action against pharmaceutical companies in overpricing cases.

In March this year, Minister of State for Chemicals Mansukh L Mandaviya said in a written reply to the Lok Sabha that since its inception, the National Pharmaceutical Pricing Authority (NPPA) issued 1,527 demand notices to companies for overcharging on sales of formulations at prices above the notified ceiling price.

He had said demand notices for Rs 5,038.72 crore were issued to companies, out of which Rs 672.28 crore had been deposited by the companies while Rs 3,469.91 crore was under litigation.

Earlier, expressing concern over future of the pharma industry in India, the Indian Pharmaceutical Alliance (IPA) had said pharma companies have become a victim of "unbridled turf war" between the Department of Pharma and drug price regulator NPPA.

In its notification, DoP further said the committee will also review the scope of the Drugs Price Control order 2013 (DPCO 2013) and suggest ways for strengthening the regulatory provisions of the order and make it more comprehensive based on past experience of its implementation.

The panel will 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 added.

The notification further said the group may also consult other government agencies, officials, representatives of industry or civil society in the interest of a more effective DPCO.

Explaining the rationale behind the step, DoP said it has received various requests, representations, including from NPPA, pharma industry associations and other stakeholders suggesting improvements in the provisions of DPCO 2013 based on the experience gained during its implementation.

In the light of these representations and to further improve affordability and accessibility of drugs for the domestic patients, the government in the department of pharmaceuticals, ministry of chemicals and fertilisers has decided to constitute the group, it added.

"In the first meeting of the committee held today it has been decided to invite comments, suggestions from all stakeholders, including civil societies/NGOs," the notification added.