New Delhi: The Hyderabad-based Hetero Labs has sought permission from the Narendra Modi government to market remdesivir in India, ThePrint has learnt.
Remdesivir is currently the most sought-after experimental drug, which has shown promise in treating the Covid-19 disease by reducing the recovery time.
Hetero Labs filed an application last week with the Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulatory body under the Ministry of Health and Family Welfare that grants approvals to new drugs and marketing licences.
Hetero Labs is one of the three Indian firms that received approval from remdesivir’s parent company, US-based Gilead Sciences, last week to manufacture the generic version of the drug in India. Gilead Sciences signed ‘non-exclusive’ agreements to allow Cipla, Hetero Labs and Jubilant Lifesciences to manufacture the generic version of remdesivir.
“It is the first company which has filed for marketing approval for remdesivir. It has also requested for the waiver of clinical trials,” a senior official from the health ministry told ThePrint.
While the company is likely to get the waiver based on the provisions for “emergency use authorisation”, the CDSCO may soon reach out to the country’s top health research body, the Indian Council of Medical Research (ICMR), for suggestions.
“The ICMR has not yet included remdesivir in the treatment protocol. We need to understand their perspective before going ahead with the marketing approvals,” said the official quoted above.
ThePrint reached Hetero Labs via email for a comment on the matter, but there was no response until the time of publishing this report.
Approval possible under new clinical trial rules
According to CDSCO’s new Drug and Clinical Trial Rules, 2019: “The requirement of non-clinical and clinical data may be relaxed, abbreviated, omitted or deferred under life-threatening or serious disease conditions or rare diseases, and for drugs intended to be used in the diseases of special relevance to Indian scenario or unmet medical need in India, disaster or special defence use.”
“However, such relaxation, abbreviations, omission or deferment of data will be evaluated on a case-by-case basis depending on the nature of the new drugs, proposed indication, etc.”
In this case, relaxation could be provided under “diseases of special relevance to Indian scenario, disaster or unmet medical need in India”.
The drug is being evaluated under several clinical trials across the globe, including the giant trial conducted by the World Health Organization, called the ‘Solidarity trial’. India is also a participant in this trial.
Drug has shown ‘clear cut’ effects
Last month, Dr Anthony Fauci, an adviser to US President Donald Trump and America’s top infectious diseases expert, said data had shown “remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery”.
Patients who were administered the drug, Fauci said, were discharged from the hospital in 11 days on average, as compared to 15 days for a placebo group, which took dummy or no pills.