India launches locally-made rare disease drugs, cost slashed by hundred-fold

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Rare disease drugs

The Union Health Ministry on Friday said that the four made-in-India drugs for rare diseases have been launched in the country. As the drugs for rare disease are being imported at expensive cost, these made-in-India drugs will slash the cost by up to hundred-fold, said the ministry.

The health ministry has prioritized 13 rare diseases along with Sickle Cell Disease in the country for which India-made drugs are to be developed. A senior official said that out of total 13 prirotised rare diseases, 6 rare diseases were identified as ‘low hanging fruits’ and work began last year to develop 8 drugs for them.

The official said, “Out of 8 drugs for 6 rare diseases, four drugs have been approved and is available in the market and other four drugs are under process for approval”.

The generic drugs have been made available for rare disease Tyrosinemia Type 1, Gaucher’s disease, Wilson’s disease, Dravet or Lennox-Gastaut Syndrome. 

Tyrosinemia Type 1 is characterised by jaundice, liver failure, liver cancer and untreated patients die after ten years. The imported drug for the disease currently costs Rs 2.2- 6.5 crore per year which will now bring down to Rs 2.5 lakh per annum. Like this, Gaucher’s disease imported drug currently costs Rs 1.8-Rs 3.6 crore, but the drug launched in India has been priced at Rs 3-6 lakh per annum. The cost of drugs for Wilson’s disease whose symptoms include copper deposit in liver, brain, cornea, currently costs Rs 1.8 to Rs 2.1 crore per annum but the generic versions will bring down the cost to Rs 2.2 lakh per annum.

For Sickle cell disease which is a genetic disorder, an Indian Pharma company has developed an oral suspension form of the drug Hydroxyurea. Earlier, capsule was used to treat the disorder which often create hurdle for child to swallow. The cost of oral suspension will bring down to 400 from current cost of Rs 70,000 per 100 ml after getting the approval. The ministry is also working with CSIR on gene therapy for the treatment of Sickle cell disease.

As per WHO, rare diseases collectively afflicts about 6-8 percent of the population in any country at any given time. India is expected to have around  8.4-19 crore rare disease cases. Nearly 80 percent of these are genetic in nature.