Medicines for four rare diseases become cheaper due to domestic production

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

Four more drugs for three diseases – Tablet Sapropterin for Phenylketonuria, tab Sodium Phenyl Butyrate and tablet Carglumic Acid for Hyperammonemia and Capsule 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 of Nitisinone capsules, used in the treatment of Tyrosinemia Type 1, will be reduced 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.

Similarly, while the cost of the imported Eliglustat capsules comes at Rs 1.8-3.6 crore per annum, the domestically manufactured capsules will now be available for just Rs 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 Rs 2.2 crore per annum but with the drug being manufactured indigenously, it will be available for Rs 2.2 lakh. The cost of the imported Cannabidiol (oral solution)used in the treatment of Dravet-Lennox Gastaut Syndrome comes at Rs 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 anemia is likely to begin by March 2024 and the tentative price would be Rs 405 per bottle.

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

All these drugs were not 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.

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

Nearly 80 per cent of these diseases are genetic in nature.