Domestic production makes medicines for 4 rare diseases cheaper


Medicines for four rare diseases have become available at drastically cheaper rates as Indian pharma companies are now producing them, reducing the reliance on expensive imported formulations, Union Health Ministry officials said on Friday, 24 November.

The slashing of prices comes as the ministry has prioritised action related to 13 rare diseases, along with sickle cell anaemia.

Reduced drug prices

Drugs for four of these diseases — Tyrosinemia type 1, Gaucher’s disease, Wilson’s disease, and Dravet-Lennox Gastaut syndrome — along with sickle cell anaemia, have been approved and are being manufactured indigenously.

Four more drugs for three diseases — sapropterin for phenylketonuria, sodium phenylbutyrate and carglumic acid for hyperammonemia, and miglustat for Gaucher’s disease — are under process for approval and are likely to be available by April 2024, official sources said.

With these drugs being manufactured indigenously, the annual cost nitisinone capsules, used in the treatment of Tyrosinemia type 1, will be reduced to one-hundredth of the price of the imported medicine.

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A significant decrease

“While the annual cost of the imported nitisinone capsule comes at ₹2.2 crore, the domestically manufactured capsules will now be available for just ₹2.5 lakh,” a source said.

Similarly, while the cost of the imported eliglustat capsules comes at ₹1.8-3.6 crore per annum, the domestically manufactured capsules will now be available for just ₹3-6 lakh per annum, the source said.

The cost of the imported trientine capsules used in the treatment of Wilson’s disease comes to ₹2.2 crore per annum but with the drug being manufactured indigenously, it will be available for ₹2.2 lakh.

The cost of the imported cannabidiol (oral solution) used in the treatment of Dravet-Lennox Gastaut syndrome comes at ₹7-34 lakh per annum but due to indigenous manufacturing, it will be available at ₹1-5 lakh per annum.

The commercial supply of hydroxyurea syrup used in the treatment of sickle cell anaemia is likely to begin by March 2024, and the tentative price would be ₹405 per bottle.

The cost of this oral suspension is $840 (₹70,000) per 100 ml from abroad.

All these drugs were not manufactured in the country till now.

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Discussions held

The source added, “The exercise started in July 2022 and discussions were held with academia, pharma industries, organisations, CDSCO, and 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.

A rare disease is a health condition of a particularly low prevalence that affects a small number of people. It collectively afflicts 6-8 percent of the population in any country at any given time and India could have 8.4-10 crore cases, the officials said.

Nearly 80 percent of these diseases are genetic in nature.

Also Read: Baby Sera, with her ultra-rare health condition, needs help

(Disclaimer: The headline, subheads, and intro of this report along with the photos may have been reworked by South First. The rest of the content is from a syndicated feed, and has been edited for style.)





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