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Thursday, March 04, 2021

Unbranded generics, ‘orphan drugs’ may go out of price control

Drugs for rare diseases are usually very expensive as pharma firms do not find it viable to sell such medicines.

Written by Deepak Patel |
May 3, 2018 2:55:06 am
Business news, nppa, essential medicines, medicines, national pharmaceutical pricing authority, drug pricing, pharma industry,  pharmaceutical industry, orphan drugs, indian express The NPTRD 2017 states: “Where, they (companies) do make drugs to treat rare diseases, they sell them at extremely high costs, statedly, to recoup the cost of research and development.” (Illustration: CR Sasikumar/Representational)

Along with restructuring National Pharmaceutical Pricing Authority (NPPA), the Central government is also considering to give itself powers to exempt ‘orphan drugs’ and unbranded generic drugs from price control.

‘Orphan drugs’ are extremely expensive, as noted in the National Policy for Treatment of Rare Diseases (NPTRD), 2017. As the number of persons suffering from rare diseases is very small, the pharmaceutical companies do not find it viable to develop and sell drugs for them. Therefore, these drugs are called ‘orphan drugs’. The NPTRD 2017 states: “Where, they (companies) do make drugs to treat rare diseases, they sell them at extremely high costs, statedly, to recoup the cost of research and development.”

The Central government is currently discussing a Niti Aayog proposal, which states: “Para 32 may be amended to add orphan drugs, unbranded generic drugs and any other drugs decided by the proposed Standing Committee on Affordable Medicines and Health Products.” Two senior Central government officials told The Indian Express that this proposal is likely to be implemented whenever NPPA is restructured.

Currently, Para 32 of the Drug (Prices Control) Order, 2013, gives the power to NPPA to exempt certain class of drugs from price control.”Now, the Central government is likely to form a ‘Standing Committee on Affordable Medicines and Health Products’, which will consist of its officials only. This committee may be given the powers to exempt certain drugs from price control through amended DPCO,” said a senior health ministry official, who is privy to the discussions.

“The unbranded generic drugs may be exempted from price control because it is important to give an incentive to drug manufacturers to produce more and more unbranded generics” the official added. Unbranded generic drugs are comparatively cheaper than branded ones. Currently, most of the drugs sold in India are branded generic drugs. When Paracetamol is sold under the brand name ‘Calpol’ or ‘Sumo’, it is called a branded generic drug. But when it is sold as ‘paracetamol’ itself, it is called unbranded generic drug.

India does not have a definition of rare disease. However, World Health Orgnaization (WHO) defines rare disease as often debilitating lifelong disease or disorder condition with a prevalence of 1 or less, per 1,000 population. Some common rare diseases are Haemophilia, Pompe disease, Thalassemia, Sickle-cell Anaemia and Gaucher’s disease. India has recorded 450 of such rare diseases, according to the NPTRD 2017. The Organisation of Pharmaceutical Producers of India (OPPI) did not comment on the specific queries sent by The Indian Express.

Malini Aisola, co-convenor of All India Drugs Action Network (AIDAN), told The Indian Express: “The proposal to exempt “orphan drugs” from price control runs counter to the NPTRD submitted in the Delhi High Court in May 2017. The policy itself was an outcome of orders passed by the Court in cases filed by patients struggling to access highly priced drugs. Pursuant to the orders, the policy was framed on the basis of recommendations of three expert committees, all of which noted the prohibitive costs of treatment which could end up in crores per year (child’s enzyme replacement therapy can range Rs 18 lakh-Rs 1.7 crore annually). As a result, the chief policy recommendation was setting up of a 100 core. corpus for funding treatment of rare genetic diseases between the centre and states.”

She added: “It is disturbing that while on the one hand the government has committed to implement the policy, the Niti Aayog is proposing that these very same treatments may be exempted from price control, which undermines the policy and further endangers access. Keeping aside that the courts have noted that the corpus is still non-functional, regulating the prices of these drugs is a critical policy tool.”

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