Indian licensees free to price Remdesivir: Gilead

New Delhi | Mumbai: US-based Gilead Sciences has said its licensed manufacturers in India are free to fix the price of Remdesivir, the experimental drug used for treating Covid-19 patients, and that its own brand of the drug will be available in the country from next month.

Earlier this week, Gilead received emergency approval from India’s drug controller to sell Remdesivir under the brand name Veklury.

Gilead has licensed the drug to four companies — Cipla, Mylan, Hetero and Jubilant Life Sciences — for sale in India, but none of these firms has received approval from the drug controller.

However, ET has learnt that most of the four companies are ready with their products and are awaiting nod from the regulator to manufacture and start selling the drug in the country.

In a statement to ET, a Gilead spokesperson said generic manufacturers would be free to set prices. “It is our hope and intent that volumes and competition will drive costs down,” he said.

A private physician in Mumbai said distributors of Hetero Pharma, one of the licensees in India, are quoting ₹7,000 per 100 mg vial for the generic version of Remdesivir — even ahead of its formal approval. At this price, a five-day full course, which was approved by the Indian authorities on Monday, would cost ₹35,000-42,000. Hetero declined to comment and ET could not independently verify these figures.

Gilead's own brand Veklury according to cost benefit modelling done by Institute for Clinical and Economic Review has estimated the price of the drug at $4460 for a full course of treatment. Gilead has not yet fixed the price for US markets.

Biopharma website EndPoints estimates that Remdesivir will be priced at $4,000 per course in Europe and $2,000 in other markets. It quoted Geoffery Porges, an analyst with Boston-based investment banking firm SVB Leerink, for the estimates. Remdesivir’s global sales are likely to touch $1.9 billion by the end of the year.

No View on Pricing Yet: Govt Officials
Government officials said they have not taken a view on the medicine’s pricing, but added that the drug pricing regulator can invoke paragraph 19 of the Drug Price Control Order of 2013 that empowers the National Pharmaceutical Pricing Authority to fix the price of any medicine in public interest or under extraordinary circumstances.

“The government is empowered to allow an increase or decrease in the ceiling price or retail price, irrespective of the annual wholesale price index for that year. Further, the drug price control order allows the NPPA to make an enquiry or seek information, if considered necessary in public interest,” said a senior official. The government had previously invoked paragraph 19 while reducing prices of stents and knee implants. Administered intravenously, Remdesivir is said to help improve the recovery time of oxygen-assisted, moderately ill Covid-19 patients. In India, in the absence of any proven therapy for Covid-19, physicians have been administering commonly available drugs such as hydroxychloroquine that costs less than Re 1 per tablet.

“We have placed orders for the drug (Remdesivir), but are yet to receive it,” said Dr Hiren Ambegaonkar, CEO of Raheja Fortis Hospital in Mumbai. The drug has been used in some government hospitals under the WHO’s solidarity trial.

STEPPING UP PRODUCTION
Keeping in view the urgent need for the drug, Gilead said it has scaled up production to increase supply.

“While there is currently limited global supply of Remdesivir, the company anticipates new supply to start becoming available in July, with supply continuing to increase through the end of this year and into next year,” the company said in its statement.

In addition to Hetero, Gilead has also entered into voluntary licensing agreements with Cipla, Mylan and Jubilant Life Sciences.

“The licences are royalty-free until the WHO declares the end of the public health emergency regarding Covid-19, or until a pharmaceutical product other than Remdesivir or a vaccine is approved to treat or prevent Covid-19, whichever is earlier,” said the Gilead spokesperson.