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Union health ministry on Friday said that Indian manufactures have started to indigenously start the manufacture of off-patent drugs used to treat 13 extremely rare diseases in order to bring down the exorbitant cost of these medicines.
The decision, taken due to repeated requests from patient groups, is likely to drop prices of treatment anywhere between one-tenth and one-hundredth of current market costs, officials said. The annual cost of treatment for some of these rare diseases can run into several crore rupees, making them far beyond the reach for most patients in India.
The government identified 13 rare diseases, along with the sickle cell disease, that manufacturers have been asked to on prioriy. Eight drugs for six of the 13 diseases are going to be available soon, with the earliest hitting shelves likely by March 2024.
According to the health ministry, four of the eight drugs are already approved for marketing and are going to be made available in market “soon” and the remaining four are nearing regulatory approvals. The six diseases are Gaucher’s disease, Wilson’s disease, Tyrosinemia type 1, Dravet/Lennox Gastaut syndrome, Phenylketonuria, and Hyperammonemia. The drugs for the final two are pending approval.
The annual costs of Eliglustat capsules, the approved medicine for Gaucher’s disease, is likely to drop from anywhere between ₹1.8crore to ₹3.6crore in India, to ₹3lakh to ₹6 lakh. Similarly, Trientine capsules used to treat Wilson’s disease will soon cost ₹2.2 lakh per annum for a child, as opposed to ₹2.2crore. The annual cost of Nitisinone capsules used to treat Tyrosinemia type 1 will drop to ₹2.5 lakh instead of ₹2.2 crore; while Cannabidiol oral solution administered to patients suffering from Dravet-Lennox gastaut syndrome will now cost ₹1-5 lakh as opposed to ₹7- ₹34lakh per annum.
All these drugs are off-patent – medicine on which there are no exclusive marketing rights – and apart from sale through manufacturers, the health ministry is also mulling making them available to patients through its Jan Aushadi stores and centre of excellences specialising in genetic research.
There is no universally accepted definition of rare disease; however, the World Health Organisation defines rare disease as often debilitating lifelong disease or disorder condition with a prevalence of one or less per 1,000 population. Different countries have their own definitions, and as per the Indian Council of Medical Research (ICMR) it is one occurance in 2,500 people.
While it is difficulat to ascertain the exact disease burden, it is estimated by applying international standards that about 6-8% of India’s population (around 100 million) is affected by a so-called “rare disease”.
“This special initiative was taken over a year ago in July last year. Discussions were held with the academia, pharma industries, civil organizations, central drugs standard control organization, department of pharmaceuticals and other stakeholders, and also facilitated interaction of drug manufacturers with the nation drugs controller to know how these imported medicines could be manufactured in India so that its easy on the pocket of patients and their families,” said VK Paul, member (health), Niti Aayog.
The oral solution for children to treat sickle cell anaemia will also be available commercially by March 2024, according to the health ministry.
“The tablets for adult sickle cell patients at nominal rates are already available in market — ₹12-15 per tablet—but oral solution for children had to be still imported and would cost around ₹70,000 for 100ml. Now that it is being manufacturing indigenously, the reduced cost is likely to fall to ₹405. This step that the government has taken will bring huge relief to patients,” said Paul.
Rhythma Kaul works as an assistant editor at Hindustan Times. She covers health and related topics, including ministry of health and family welfare, government of India.
Cheaper Made-in-India drugsto treat extremely rare diseases – Hindustan Times
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