New Delhi: The Modi government’s expert panel has rejected the proposal of Dr Reddy’s Laboratories to grant emergency use authorisation to a Russian rheumatoid arthritis drug, which was repurposed for Covid-19.
The drug, Olokizumab, is manufactured by Russian drug maker, R-Pharm, to treat rheumatoid arthritis drug, which the company is now trying to repurpose for Covid-19.
In India, Dr Reddy’s — which is also conducting clinical trials of Russian vaccine, Sputnik, in India — has applied for the marketing nod.
In a meeting held on 18-19 January, the government’s subject expert committee (SEC) rejected Dr Reddy’s proposal to grant emergency marketing of the monoclonal, antibody-based drug in Covid-19 indication “with waiver of clinical trial”.
The panel in the same meeting also rejected the proposal of Natco pharma for the waiver of local trials of another rheumatoid arthritis drug, also a monoclonal, antibody-based treatment, Baricitinib, which is originally manufactured by US drug major Eli Lilly.
The SEC advises the apex drug regulator, Drug Controller General of India (DCGI), on applications seeking approvals for new drugs, vaccines and clinical trials.
DCGI heads the Central Drugs Standard Control Organisation (CDSCO), the health ministry arm that regulates the quality of drugs and vaccines in India.
Earlier, India has granted emergency use authorisation status to drugs such as Remdesivir and Favipiravir. However, their local local clinical trials were conducted.
Drug not approved by Russian regulator
The panel said, according to the minutes of the meeting uploaded on the CDSCO website, “The committee noted that the drug is not approved in India for any indication. Further based on the presentation, for Covid-19, it is not approved by the regulatory authority of Russia.”
“After detailed deliberation, the committee did not recommend for the approval of the drug for restricted emergency use in India.”
Similarly, for Natco, who had also submitted the “justification” for the local clinical trial waiver of Baricitinib tablets for restricted emergency use for Covid-19, the panel recommended that “the firm should conduct the Phase III clinical trial”.
“Accordingly, the firm should submit the Phase III clinical trial protocol for further review,” the minutes said.
Status of the two repurposed drugs
In October, last year, the Russian drug maker’s Chief Medical Officer Mikhail Samsonov told Reuters in an interview that “the drug has been included in national guidelines for treating patients with moderate Covid-19 infections and early signs are encouraging”.
While he had said that “the data on a 372-person placebo-controlled, randomised clinical trial, are due to be published in late October or early November”, the results aren’t published yet.
For Natco’s drug, according to the trial results published in December in the New England Journal of Medicine, the combination of Baricitinib and Remdesivir had shown to reduce the median time to recovery when compared with Remdesivir plus placebo.
“Baricitinib plus Remdesivir was superior to Remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation,” the study noted.