Anti-COVID pill likely to get approval in India soon, DCGI reviews clinical data

The Drugs Controller General of India (DCGI) is reviewing the clinical data of molnupiravir, for the treatment of COVID-19 in adults in India. The review stands as proof that the anti-COVID pill is likely to get approved for emergency use in India. Merck Sharp Dohme (MSD) and Ridgeback's molnupiravir had earlier become the world's first anti COVID pill after it gained approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA). The approval was given for the treatment of mild-to-moderate COVID-19 in adults in the United Kingdom.

Sun Pharmaceutical Industries on Thursday, November 11, said that it was now getting ready to introduce MSD and Ridgeback's molnupiravir for the treatment of adults in India. According to the company, the pills will be introduced under the brand name Molxvir. Earlier this year, Sun Pharma had signed a non-exclusive voluntary licensing agreement with MSD to manufacture and supply the anti-COVID pill in India. The deal also included the delivery of pills to over 100 low- and middle-income countries.

Sun Pharma in a statement confirmed that the company is looking forward to introducing the pills at an economical price across India. "The recent authorisation of molnupiravir, licensed from MSD and Ridgeback, by the UK regulator is a positive step. In line with our consistent efforts to accelerate access to new drugs for COVID-19 treatment, we are gearing up to make Molxvir available to patients and healthcare providers across India at an economical price post-approval by DCGI," Sun Pharma India Business CEO Kirti Ganorkar said in a statement. The US is also looking at the clinical data of the anti-COVID pill.

Pfizer claims its antiviral pill reduces hospitalisation and death risk by 90%

Earlier last week, Pfizer Inc. claimed that its COVID-19 antiviral pill minimised hospitalisation and death risk by 90% among at-risk adults. The assertions come as the company joins the race to bring the first-easy-to-use coronavirus treatment to the market in the US, as per AP. Following the announcement, Pfizer stated that it will approach Food and Drug Administration (FDA) and international regulators to approve the drug as soon as feasible. If approved, the pill will be marketed by the name Paxlovid.

With agency inputs

Image: AP