While the US pharma company, Gilead Sciences, has been granted authorisation for restricted emergency use of remdesivir to treat Covid-19 patients, the Indian players are yet to receive any marketing authorisation. Moreover, it is learnt that they have not yet approached the National Pharmaceutical Pricing Regulator (NPPA) for discussions on how to price this injectable drug that will be used on hospitalised patients.
Sources indicated that the pharma companies are in touch with the various government departments and recently there was a video conference between the drug makers and various government departments. However, no decision on pricing has been taken yet. As for the dosage, sources claim that it will be decided by the country's apex health research body the Indian Council of Medical Research (ICMR), which is yet to come out with an advisory on remdesivir dosage for patients.
"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 the license to manufacture the drug, but they now need authorisation to market the drug in India," said a senior government official. However, it is learnt that Indian drug makers are yet to get the nod from the regulator.
The stock prices of Jubilant Life Sciences went up 5 per cent on Tuesday after the news of Gilead securing the nod came in. Meanwhile, Cipla stock price was down marginally. Gilead has signed non-exclusive license agreements to manufacture and distribute the drug with Cipla, Jubilant Life Sciences, Hetero and Mylan here in India apart from Pakistan-based Ferozsons Lab. Mylan would be using India as the manufacturing base for remdesivir globally.
Another senior government official close to the development said that the companies are yet to officially approach the NPPA or the pharma pricing regulator for finalising a price for the injectable drug. "It is a complex process to make the formulation, and thus the pricing cannot be very cheap. 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 the license to make and market the drug.
Cipla and Hetero did not wish to comment for the story. E-mails sent to Mylan and Jubilant also did not elicit an immediate response.
Government officials feel that since the active pharmaceutical ingredients (APIs) as well as the key starting material (KSM) would be made in India, the pricing of the drug would become affordable. "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 fully vertically integrated to make remdesivir here and is keeping a stock of API to make 1 million doses.
An email sent to Gilead remained unanswered till the time of going to press.
The approval process for remdesivir was accelerated in the wake of the pandemic in India. It would be now used on hospitalised Covid-19 patients who have severe symptoms. A written consent letter will be required from the patient before administering the drug as the medicine still does not have the approval as a cure for Covid-19. It is being used on compassionate grounds. According to the New Drug and Clinical Trial Rules 2019, in special circumstances (like the Covid-19 outbreak) a drug can be approved for use before clinical trials. Clinical trial data, however, needs to be subsequently submitted with the authorities. At the moment, 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 Mumbai hospitals. This, however, could not be independently verified from the companies.
Meanwhile, on Monday, Gilead announced the topline results from phase 3 SIMPLE trial in hospitalised patients with moderate Covid-19 pneumonia. The study showed that patients with a 5-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 improvment in clinical status of statistical significance.
The US Food and Drug Administration (USFDA) granted remdesivir an emergency use authorization for the treatment of hospitalized patients with severe Covid-19.The authorization is temporary and does not take the place of the formal new drug application submission, review and approval process. "This is also the reason why India has granted a restricted emergency use authorisation that will be reviewed later in the light of clinical trial data. As of now no clinical trial data was sought to grant the approval," said a government official.