Indian drug firms await nod to market remdesivir
Firms also haven’t approached regulator for discussions on pricing the injectable drug
Indian players are yet to receive approval to market remdesivir, even as the United Statesbased Gilead Sciences has been granted authorisation for restricted emergency use of the drug to treat Covid-19 patients. It is also learnt that the firms haven’t yet approached the National Pharmaceutical Pricing Authority formally to discuss the pricing of the drug.
While Us-based Gilead Sciences has been granted authorisation for restricted emergency use of remdesivir to treat Covid-19 patients, Indian players are yet to receive approval to market the drug.
Moreover, the firms haven’t yet approached the National Pharmaceutical Pricing Authority (NPPA) formally to discuss pricing of the drug, which will be used on hospitalised patients, a senior government official close to the development said.
Sources said the pharma companies are in touch with various government departments and there was a video conference meeting recently. However, no decision on pricing has been taken yet. As for dosage, sources say it will be decided by the Indian Council of Medical Research (ICMR), which is yet to come out with an advisory.
“We are trying to sit down with these drugmakers and see how this particular drug can be brought into the market soon. They have licence to manufacture the drug, but need authorisation to market it in India,” said a senior government official. The Indian drugmakers, however, it is learnt, are yet to get approval from the regulator.
The stock price of Jubilant Life Sciences went up 5 per cent on Tuesday after news came in of Gilead securing the nod. Meanwhile, Cipla’s stock price was down marginally. Gilead has signed non-exclusive licence agreements to manufacture and distribute the drug with Cipla, Jubilant Life Sciences, Hetero, and Mylan in India, apart from Pakistan-based Ferozsons Lab.
Regarding pricing the formulation, a senior executive of one of the drug firms said: “It is a complex process to make the formulation, and, thus, the pricing cannot be very low. However, no company is trying to use this as an opportunity to make high margins. It is an emergency, and, thus, the drug would be priced keeping in mind our social responsibility.”
Cipla and Hetero did not wish to comment. E-mails sent to Mylan and Jubilant did not elicit a response.
Government officials felt since active pharmaceutical ingredients (APIS), as well as key starting material (KSM), would be made in India, the drug could be priced affordably. “Gilead has signed licensing agreements with Indian drugmakers to manufacture and distribute the drug in 127 countries. Manufacturing in India would make remdesivir affordable for the world,” the official added. He clarified Gilead can also market the drug under its own brand in India.
Hetero, for example, is vertically integrated to make remdesivir here and is keeping a stock of API to make 1 million doses. An e-mail sent to Gilead was unanswered at the time of going to press.
The approval for remdesivir in India was accelerated in the wake of the pandemic. It would now be used on hospitalised Covid-19 patients who have severe symptoms. A written consent letter from the patient is to be taken before administering the drug as the medicine still has still not been approved as a cure. It is being used on compassionate grounds.
According to the New Drug and Clinical Trial Rules 2019, in special circumstances a drug can be approved for use before clinical trials. Clinical trial data, however, needs to be subsequently submitted. At present, the regulator has sought monthly data on patients who will be administered the drug.
Sources also indicate some batches of
the medicine have already been procured for hospitalised patients in Mumbai. This could not be independently verified.
Meanwhile, on Monday, Gilead announced the top line results from phase 3 SIMPLE trial on hospitalised patients with moderate Covid-19 pneumonia. The study showed patients with a five-day treatment of remdesivir were 65 per cent more likely to have clinical improvement on Day 11, compared to those who were not given the drug. A 10day course, however, did not show any improvement of statistical significance.
The US Food and Drug Administration has granted remdesivir emergency use authorisation for treatment of critically ill Covid-19 patients. “This is also the reason for India granting restricted emergency use authorisation, which will be reviewed later in the light of data. No clinical trial data was sought to grant the approval,” said a government official?.