On June 13, the Indian Council of Medical Research came out with guidelines on the use of remdesivir. (File Photo)
Amid instances of patients attempting to import antiviral drug remdesivir from Bangladesh for Covid-19 treatment, India’s top drug regulatory body has said it will block any supplies coming from there illegally.
“There is no approval for those companies (in Bangladesh), so how can it be imported?” a senior official with the Central Drugs Standard Control Organisation (CDSCO) said, on condition of anonymity.
Adding that the regulator is performing checks on the quality of remdesivir manufactured by generic drug makers in India, the official added, “For now, the main focus is to stop such imports (from unapproved suppliers).”
Demand for remdesivir, still an investigational drug for use in treating coronavirus, has been on the rise after Drug Controller General of India Dr V G Somani granted emergency use approval for its supply to Gilead Sciences, the firm that developed it, on June 1. Approval was also given to Mumbai-based Klinera Global Services to import the product.
On June 13, the Indian Council of Medical Research came out with guidelines on the use of remdesivir.
Yet, there has been little to no supply from Gilead since it received the approval, according to the official. It is unclear how many vials, if any, have been imported, as queries to Klinera and Gilead remained unanswered.
In a release on June 3, Gilead had stated there was “limited global supply” of remdesivir and that it anticipated new supply to become available only in July.
In the meantime, the CDSCO has been allowing generic drug makers seeking approval to manufacture and market their copies of remdesivir to provide samples to patients on “compassionate use grounds”.
The official added that six Indian firms had applied so far to the CDSCO for approval, and their applications were being processed “on priority”. “It is a matter of a few days.”
Among patients for whom remdesivir was sought for treatment was former Maharashtra MP Haribhau Jawale, who passed away on Tuesday. Dr Gautam Bhansali of Bombay Hospital, who was treating him, said Jawale, who was 67 and suffered from chronic asthma, had pneumonia and after his oxygen saturation levels stayed lower than 90 the past few days, they decided to give him remdesivir. “He was going to be administered the drug today. But he passed away before that,” Dr Bhansali said, while refusing to say how they had procured it.
Fortis Flt Lt Rajan Dhall Hospital in New Delhi has been trying to get remdesivir for patients on compassionate grounds, procuring it on donation from BDR Pharmaceuticals, based in Delhi. “A lot of patients are asking about this drug. We have used it on three patients so far,” Director, Pulmonology, at the hospital Dr Vivek Nangia said, adding that they had not seen any improvement in survival rates of patients administered the drug so far.
Patients have also been importing the drug for personal use from the US, EU and Dubai using Rule 36 of the Drugs and Cosmetics Rules, 1945, said a senior Mumbai-based doctor. This can be done on the basis of a doctor’s prescription. “So far, I am not aware of patients who have imported the drug from Bangladesh,” the doctor told The Indian Express.
However, some medical professionals and patients have studied the possibility of doing so in the past two weeks. “I was considering remdesivir as plan B for one of my patients, whose condition was severe. I knew it was not easily available here, so I tried to find suppliers. I heard it was possible to get supplies from Bangladesh, but I was not sure whether it was legal,” a Delhi-based doctor said. “Luckily, my first option of treatment worked on the patient and I didn’t need to import the drug.”
Mumbai, the largest hotspot for Covid-19 in India, is also seeing high demand for the drug. A doctor at Bhatia Hospital said families of six patients had requested that remdesivir be administered to them. “Four were able to procure it, how and at what cost we don’t know,” a senior doctor told The Indian Express.
Infectious disease specialist Dr Om Srivastava said he has been approached by “several” patients willing to procure remdesivir on their own. “The drug efficacy or stability is not known… there may be adverse reactions in a patient. I have been refusing all patients who have requested to buy remdesivir on their own,” he said.
Maharashtra FDA Commissioner A B Unhale maintained that “there is no supply locally available in Maharashtra for remdesivir”. “If a patient’s relative couriers the medicine from, say, the US, we cannot do anything about it,” he added.