Prices Of Drugs For 4 Rare Diseases Drastically Come Down In India After Domestic Production

The Centre has approved the domestic production of medicines used in the treatment of four rare diseases leading to a sharp decline in their prices.

The Union Health Ministry has said that Indian pharma companies have started producing medicines for four rare diseases reducing its prices drastically minimising the reliance on expensive imported formulations, reported PTI citing officials from the ministry. Drugs for four diseases -Tyrosinemia Type 1, Gaucher's Disease, Wilson's Disease and  Dravet-Lennox Gastaut Syndrome - along with sickle cell Anemia have been approved and are being manufactured indigenously, the agency added in the report. This comes as the ministry has prioritised action related to 13 rare diseases along with sickle cell anaemia. 

According to PTI, tablet Sapropterin for Phenylketonuria, tab Sodium Phenyl Butyrate and tablet Carglumic Acid for Hyperammonemia and Capsule Miglustat for Gaucher's disease are under the process for approval and are likely to be available by April 2024, official sources said.

PTI cited sources that the manufacturing of these drugs indigenously would cut the annual cost of Nitisinone capsules, used in the treatment of Tyrosinemia Type 1, to one-hundredth of the price of the imported medicine.

"For example, while the annual cost of the imported capsule comes at Rs 2.2 crore, the domestically manufactured capsules will now be available for just Rs 2.5 lakh," a source said, as quoted by PTI.

In the same way, the cost of the imported Eliglustat capsules, which comes at Rs 1.8-3.6 crore per annum, will now be sold for just Rs 3-6 lakh per annum, the source told news agency PTI. It further added that the cost of the imported Trientine capsules, which are used in the treatment of Wilson's disease, will go down to  comes to Rs Rs 2.2 lakh per annum instead of 2.2 crore per annum.

Imported Cannabidiol (oral solution), used in the treatment of Dravet-Lennox Gastaut Syndrome, will now be available at 1-5 lakh per annum instead of previous cost of Rs 7-34 lakh per annum due to indigenous manufacturing.

The report mentioned that the commercial supply of Hydroxyurea Syrup that is used in the treatment of sickle cell anemia is likely to begin by March 2024 and the tentative price would be Rs 405 per bottle. It costs 840 USD (Rs 70,000) per 100 ml in abroad. Notably, none of these was manufactured in the country till now.

"The exercise started in July 2022 and discussions were held with academia, pharma industries, organisations, CDSCO, Department of Pharmaceuticals after which 13 rare diseases were prioritised along with sickle cell anaemia. After this interactions were held with drug manufacturers and the Drugs Controller General of India and these drugs were approved and prices were slashed," the source said, reported PTI.

The officials said that a rare disease is a health condition of a particularly low prevalence that affects a small number of people. It affects 6-8 per cent of the population in any country at any given time and India could have 8.4-10 crore cases. They said that nearly 80 per cent of these diseases are genetic in nature.