Covid-19 crisis: Indian drug companies yet to get nod to market remdesivir

Government officials feel that since the APIs as well as the key starting material (KSM) would be made in India, the pricing of the drug would become affordable.
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, it is learnt that the firms haven’t yet approached the National Pharmaceutical Pricing Regulator (NPPA) formally to discuss pricing of the drug, which will be used on hospitalised patients.

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 drug makers 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 drug makers, 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.

Another senior government official close to the development said the companies are yet to officially approach the NPPA for finalising a price. “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,” said a senior official of one of the drug firms that has licence to make the drug.

Cipla and Hetero did not wish to comment on the story. E-mails sent to Mylan and Jubilant did not elicit a response.

Government officials felt that since the active pharmaceutical ingredients (APIs) as well as the key starting material (KSM) would be made in India, the drug would be priced affordably. “Gilead has signed licensing agreements with Indian drug makers to manufacture and distribute the drug in 127 countries. Manufacturing in India would make remdesivir affordable for the world,” the official added. He clarified that 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 that some batches of the medicine have already been procured for patients in hospitals in Mumbai. This, however, 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 that 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 10-day course, however, did not show any improvement of statistical significance.

The US Food and Drug Administration (USFDA) granted remdesivir emergency use authorisation for treatment of hospitalised patients with severe Covid-19. 

“This is also the reason why India has granted restricted emergency use authorisation that will be reviewed later in the light of data. As of now, no clinical trial data was sought to grant the approval,” said a government official.

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