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Generic drugs to treat four rare diseases launched

Providing relief to patients with rare diseases across India, the Union Health Ministry has made available generic drugs to support the care and treatment of four ailments: Tyrosinemia-Type 1, Gauchers Disease, Wilson’s Disease, and the Dravet-Lennox Gastaut Syndrome. This means that the cost of these drugs will be slashed by anywhere between 60 and 100 times of their current market value.

The Ministry is also in the process of making available drugs for more rare diseases, including Phenylketonuria and Hyperammonemia, over the next few months. “The approvals for these drugs are awaited,” said V.K. Paul, NITI Aayog’s member with expertise on health issues. He added that this initiative would also result in patients’ costs dropping from crores annually to mere lakhs. Additionally, a sickle cell disease drug formulation will now be made available for children.

A rare disease is a health condition of particularly low prevalence that affects a small number of people. It collectively afflicts 6-8% of the population in any country at any given time, so India could have 8.4 crore to 10 crore such cases, according to the Ministry. Nearly 80% percent of these diseases are genetic in nature.

Priority diseases

“To bring in these drugs a special initiative was taken, and discussions were held with academia, pharma industries, organisations, the Drug Controller, and the Department of Pharmaceuticals. Thirteen rare diseases were prioritised. We particularly worked on sickle cell disease, and on the syrup for children under five who can’t be administered tablets,” said Health Minister Mansukh Mandaviya.

“This venture is purely a non-commercial venture guided only with the motive to serve those in acute need. For years, the Health Ministry through various schemes has been trying to financially help as many patients as possible but this is a more sustainable measure for not just patients in India but also worldwide,” he said.

Dr. Paul added that the Ministry was also engaging with companies who are selling patented rare disease drugs. “We are actively looking at how best to work for patients who urgently need these medicines,” he explained.

Several companies — including Biophore India, Laurus Labs, Azico Biophore, MSN Pharmaceuticals, Akums Drugs and Pharmaceutical – have come forward to take part in the venture.

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