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Health groups express concern over proposed move to amend regulatory framework for pharmaceuticals

Health groups are raising grave concerns over recent reports that the government, through discussions with the Niti Ayog, is proposing sweeping changes to the regulatory framework for pharmaceuticals, which will grievously impact access to affordable medicines. Ignoring the reality of unacceptability high out-of-pocket spending on medicines, the government is proposing to dismantle the National Pharmaceutical Pricing Authority (NPPA) and remove or significantly dilute price controls on essential medicines.

In a joint statement several health groups have said that the move towards dismantling price controls on essential medicines and winding up of the National Pharmaceutical Pricing Authority (NPPA) are being advanced at the behest of industry lobbies, under the pretext of removing “”unnecessary hurdles”” and “”ease of doing business”” in India and with little or no proper public consultation. These ill-conceived attempts to de-regulate the medicines market and in particular the prices of essential medicines will not only result in a surge in the prices of commonly used medicines but also violate Supreme Court directions to regulate the prices of all essential and life saving medicines, the statement said.

These reports come just a few days prior to a critical hearing in the Supreme Court on 9 November challenging the government’s current approach of market based drug pricing.

“”Even the existing system of price control has been watered down and greatly compromised through years of industry lobbying. Instead of dismantling the system, the government must reform it to remove market-based-pricing and replace it with a cost-based pricing mechanism,’’ said Narendra Gupta of Jan Swasthya Abhiyan.

Nearly 80 % of medical care costs have to be paid by the patients out of pocket, of which 70% of the expenditure is on medicines. Denial of essential life saving medicines due to the lack of affordability and indebtedness is a harsh reality. A distorted market cannot, and should not, be the basis of drug pricing and policy, especially when the sale price has no bearing with the cost of production and purchasing power of our people, added Mira Shiva of the All India Drug Action Network which is the petitioner in the ongoing case before the Supreme Court.
Reports of attempts being made in parallel to introduce new rules for marketing approval of drugs have also raised concerns as the purpose of these new rules remains unclear and they may create significant barriers in the registration of generic medicines.

“”The exorbitant prices of patented medicines are already a matter of great concern. Cancer drug prices are in lakhs of rupees while new injections can cost tens of thousands. Not only has the government done little to regulate the prices charged by multinational companies or issue compulsory licenses to ensure the availability of affordable generic versions, it now appears that greater barriers to the registration of generic medicines many be on the anvil,’’ said Dinesh Abrol, Convenor of the National Working Group on Patent Laws.

The government has reneged on its election promises to ensure access to medicines. These moves will only increase out-of-pocket spending on medicines and influct injury on a hapless populace, asked Anurag Bhargava of AIDAN.

The groups are urgently calling on the government to abandon the ill-conceived ideas of dismantling the NPPA and diluting the DPCO and to prioritse public health and the right to life and health of patients in India.”

By TIS Staffer
the authorBy TIS Staffer

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