Covid-19 crisis: Made-in-India remdesivir may come by end of June

Gilead’s remdesivir, the only drug with an emergency use authorisation to treat Covid-19 in the US, is expected to be widely available in the Indian market by the end of this month, sources in the know said. The drug may reduce the average time of hospital stay for Covid patients and improve their recovery time.

Currently, the drug is allowed for “restricted emergency use” on severely ill hospitalised Covid patients in India. The antiviral drug may cost around Rs 55,000 for an 11-dose course, or Rs 5,000 per injection — much less than the price of imports from Bangladesh. Domestic pharmaceutical companies claim India is fully vertically integrated to make remdesivir, and there is no reliance on China for any ingredient.

After Gilead’s repurposed drug came into the limelight, the US firm signed licence agreements with Indian manufacturers around mid-May to make and sell the drug in India and other countries.

In the first week of June, the firm got approval for remdesivir from the Indian drug regulator. Indian licencees — Cipla, Hetero, Zydus Cadila, and Dr Reddy’s Laboratories — as well as Dutch firm Mylan, which will make the drug in India, are, however, yet to get a formal nod from the Drug Controller General of India (DCGI).

With the growing clamour for the drug, states like Maharashtra have considered importing it from companies in Bangladesh. In some cases, individual patients have sought the drug regulator’s nod to import the drug. Multiple sources now indicate that remdesivir would soon be available in India from domestic players.

A senior executive of one of the licencees said the Central Drugs Standard Control Organisation (CDSCO) had sought stability data to ensure the drug was safe to use once in the market. “The central drug testing laboratory was to review the test batches submitted by the manufacturers for stability. If things go well, the approval can come in eight to 10 days, and the drug will be available in the market by the end of this month,” he said. He further added the drug would be priced competitively in the Indian market and the price could be around Rs 5000 for a dose. Each patient will need eleven doses, taking the cost of treatment to about Rs 55,000.

Another licencee confirmed that the pricing of remdesivir would be around that much, and added that market dynamics would keep the price in check. “India is a fairly efficient market in terms of competition. Price will be a dynamic thing depending on demand and supply, but it will not be a bottleneck for patients. Today a patient is paying anything between Rs 35,000 and Rs 60,000 a day in hospitals. This drug reduces at least three to four days of one’s hospital stay. In that way, the drug will pay for itself,” he said.

Industry sources said pharma firms in Bangladesh were importing the active pharmaceutical ingredients from China and thus they were quoting a much higher price — around Rs 10,000 for a vial.

A Gilead spokesperson had told Business Standard earlier that the primary purpose of filing the new drug application in India was to support the voluntary licencees based in India. “The timeline to get remdesivir to the Indian patients that need it will depend on the licencees and a process that Gilead does not control. Our individual licencees will also file applications with the CDSCO to manufacture and sell remdesivir, while waiving the requirement for undertaking local clinical trials,” the spokesperson had said.

The Indian licencees have been in regular contact with the CDSCO, which too wants to bring in the domestically made drug into the market soon. A CDSCO source told Business Standard that one has to weigh the safety and do a risk-benefit analysis in such a critical situation.

An industry source said the CDSCO had asked for stability and toxicology data, which would be submitted “by the end of this week or so”.

Industry sources said if the DCGI did not take a decision by next week based on the data available to give approval to the Indian licencees, the next set of additional data would take at least 60 days to generate.

Meanwhile, pressure is mounting on the government to make the drug available here soon. Sanjay Oak, leader of the Maharashtra task force of doctors on Covid-19, has requested the state government multiple times to make the drug available soon. The state government thus considered importing it from companies in Bangladesh, which do not have any licence to make the injectable. “The drug is available in the Indian market unfortunately. The risk is the product is not even approved in Bangladesh,” said one of the companies that has Gilead’s licence. – Business Standard