Mumbai: A government expert panel on Covid-19 under the Union health ministry has rejected full regulatory approval for anti-viral drug, Remdesivir, saying ‘restricted emergency use’ of the drug for treatment in Covid-19 will continue. The Subject Expert Committee (SEC), in its meeting on October 29, shot down Hyderabad-based Dr Reddy’s proposal seeking a change in the approval of Gilead’s Remdesivir from restricted emergency use to a full marketing nod.
Under restricted use to a new unapproved drug, the patient has to provide a signed consent form before treatment is initiated. This is because there is not enough data to support the claim that the therapy works, hence patients’ consent is important. As against this, in a full regulatory approval, the drug can be dispensed with a doctor’s prescription, with no consent from the patient.
There is rampant use of Remdesivir to treat moderate-to-severe Covid-19 patients here in India, though doctors earlier told TOI that its indiscriminate use needs to be curbed. Over the past few months, Remdesivir has been controversial in the wake of its indiscriminate use, shortages, price gouging and recently, a full approval by USFDA despite lack of robust global data in the treatment of Covid-19. It received a full go-ahead by USFDA on October 22 for use in adult and paediatric (12 years and above) Covid-19 hospitalised patients, even as the World Health Organisation’s Solidarity Trials showed that it was ineffective in reducing mortality or duration of hospital stay. Earlier in May, Veklury or Remdesivir was authorised only for emergency use by the US regulator.
In another development, the SEC rejected an application of Dr Reddy’s to grant emergency approval to a potential cancer drug, Deoxy-D-Glucose oral powder for use in Covid-19 patients. The company was earlier granted approval to conduct Phase 3 clinical trials to study the drug’s safety and effectiveness as a potential Covid-19 therapy.
Emails and calls to Dr Reddy’s were not answered till the time of going to press.
After detailed deliberation, the SEC “reiterated its earlier recommendation in respect of their proposal and did not recommend for approval of the drug for restricted emergency use as no additional data was presented’’, according to minutes of the meeting accessed by TOI.
The SEC advises the apex regulator, Drug Controller General of India, on applications seeking approvals for new drugs, vaccines and clinical trials. Regarding Phase 3 clinical trials, the SEC said 28 days mortality should be included as one of the efficacy end points.
Further, the expert panel rejected Sun Pharma’s proposal to grant restricted emergency use to Cocculus hirsutus, a plant-based drug. The company had sought approval for the drug’s restricted emergency use, along with presenting Phase 2 clinical trial results. The committee observed that trial results have failed to meet efficacy end-points, and overall, the scientific data was not satisfactory.
The trials on AQCH, a phytopharmaceutical (plant derived) drug for treatment of Covid-19, were started in June. AQCH, which is being developed for dengue, has shown broad antiviral effect in in vitro studies and hence, was being tested as a potential treatment option for Covid-19, the company said earlier.



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