Rajya Sabha

July 28, 2016

Ahmed Hassan Imran speaks on drug pricing during Calling Attention Motion

Ahmed Hassan Imran speaks on drug pricing during Calling Attention Motion

Sir, my first issue is ban on common drugs.

In March, 2016, the Government of India issued a notification banning 344 fixed drug combinations which include some common cough mixture solutions, analgesics and antibiotic combinations which are sold over the counter.

I would like to know from the Hon’ble Minister what kind of measures is the Government taking to ensure that this ban is implemented in letter and spirit? Also, have the State Governments been taken on board for executing the same?

My question number two is on the status of the inter-ministerial committee.

In July 2015, the Supreme Court asked the Centre to set up an inter-ministerial committee comprising representatives from Department of Industrial Policy & Promotion (DIPP), Ministry of Health, National Pharmaceutical Pricing Authority (NPPA) and Department of Pharmaceuticals to look into the pricing of medicines. The last drug price control order came in 2013 and the one before that in 1995. What is the current status of this committee? Is the drug price control order going to be revised as per current market requirements?

My third question for the Hon’ble Minister is regarding legal compliance.

Recently, the Indian pharma industry has been facing the heat from the US Food and Drug Administration for non-compliance of regulatory framework. In the recent past, many domestic generic drug makers have faced action, including Sun Pharma and Wockhardt.

Furthermore, the Hon’ble Minister of Commerce and Industry , in a written reply, stated in Lok Sabha that 29 cases of fraud have been reported in the special economic zones (SEZs). This has a serious impact on patients who depend on life-saving drugs.

What is the Government doing to ensure compliance of regulatory framework especially under Food Drug and Cosmetic (FD&C) Act and related laws? Why is the current regulatory framework failing to meet quality and legal standards?

My last question to the Minister is regarding pharma patents and exports to developing countries.

In the past month, there have been reports that India is following US-style patent protections on pharmaceuticals and that there is pressure to limit India’s exports to developing countries, especially those in the African continent. India is currently one of the leaders in export of global generics and competes directly with big pharma companies in making medicines affordable, primarily in developing countries.

My question is, have patent protections been made stricter in India? Is the Government planning to introduce changes in the Intellectual Property Law or in voluntary licensing that will diminish exports of generic drugs to developing countries?

Thank you, Sir.