When reports of the United States securing almost all of the world’s stock of remdesivir (an investigational antiviral drug for COVID-19) for the next three months came out, concerns over the availability of the medicine for moderate cases (on oxygen support) in the rest of the world came to the fore.
Remdesivir, the only drug that has an emergency use authorization from the Food and Drug Administration (FDA) for COVID-19, is patented by the US pharma giant Gilead Sciences. The company had first developed it to work against Ebola (where it failed), but remdesivir has now resurfaced as a potential medicine for COVID-19 treatment - even though trials are ongoing and evidence has been mixed.
The Department of Health and Human Services announced on 29 June that it had bought 100% of Giliead’s projected production for July and 90% of its production for August and September, reported CNN. In a press release, the HCC secretary Alax Azar said, “President Trump has struck an amazing deal to ensure Americans have access to the first authorized therapeutic for COVID-19.”
Owing to the patent, such a development could be worrying for high-income countries, including many European nations and China, Japan and Brazil, among others. But what does it mean for India?
Generic Drug Makers of Remdesivir in Developing Countries
In May, Gilead Sciences signed non-exclusive voluntary licensing agreements with six Indian pharmaceutical companies to boost the supply of remdesivir.
Gilead has also signed agreements with generic pharmaceutical manufacturers based in Egypt and Pakistan. In all, this will allow the following companies to manufacture remdesivir for distribution in 127 countries – Cipla Ltd.; Dr. Reddy's Laboratories Ltd.; Eva Pharma; Ferozsons Laboratories; Hetero Labs Ltd.; Jubilant Lifesciences; Mylan; Syngene, a Biocon company; and Zydus Cadila Healthcare Ltd.
In a statement, Gilead said, “The countries consist of nearly all low-income and lower-middle income countries, as well as several upper-middle- and high-income countries that face significant obstacles to healthcare access. The regulatory approval status of remdesivir varies by country, and the distribution of remdesivir within each country listed below is subject to local laws and regulations.”
A list of these countries can be found here.
Who Can Make the Drug in India?
Drugs Controller General of India approved remdesivir for restricted emergency use for the treatment of suspected or laboratory-confirmed COVID-19 cases in adults and children hospitalised with severe symptoms.
Drugmakers Cipla Limited and Hetero Healthcare Limited, on Sunday, 21 June announced the launch of their generic versions of remdesivir - named Cipremi and Covifor respectively - after they received the approval to manufacture and market the drug from the DCGI.
According to an Economic Times report, Hetero said it has so far supplied 20,000 doses of the drug, of which half went to Tamil Nadu which had made advance purchases, 7,000 went to private hospitals and the rest to other state-run hospitals in the country.
A press release by the company from 24 June reads, “Following the approval of ‘COVIFOR’, the generic of Remdesivir by DCGI, Hetero Healthcare Limited, a group company of Hetero is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra; while the other lot will be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Trivandrum and Goa within a week’s time, in order to meet the emergency requirements.”
Cipla, on the other hand, is expected to start its supply of Cipremi on 9 July, the ET report states. Five more companies are expected to launch their versions of Remdesivir in India in the next few months.
What Is Remdesivir Priced At?
Gilead announced in a letter that it had decided to set a price of $390 per vial for governments of developed countries. A typical five-day treatment course would include six vials, which would equate to $2,340 per patient. The price for a US patient (those on private insurance or the government Medicare and Medicaid programs) will be $520 per vial, amounting to a total of $3,120 for a five-day treatment, CNN reported.
In India, Hetero has priced Covifor at Rs 5,400 per vial. It needs to be administered intravenously in a hospital, critical care setting, under the supervision of a registered medical practitioner.
Cipla will reportedly be pricing Cipremi below Rs 5,000 per vial.
Therefore, the typical five-day treatment involving the use of six vile could cost above Rs 30,000 using either of the generic drugs.
Can I Get it For Myself?
No, the medicine cannot be used by an individual for self-medication. PTI reported that “the injectable drug can be sold by retail on the prescription of specialists for use in hospital or institutional setup only.”
“The drug is given in the form of an injection and that is why it has to be administered under the supervision of a doctor in a hospital setting,” the news agency quoted a source.
The ‘written informed consent’ of each patient would have to be taken.
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