Indian firm launches Merck’s Covid pill
NEW DELHI: Drug major Mankind Pharma and generics maker BDR pharmaceuticals on Wednesday announced launch of Merck’s oral Covid-19 anti-viral pill Molnupiravir under the brand name Molulife.
Over a dozen Indian companies have publicly stated they will produce the pill, the patent for which was freed for low- and middle-income countries by the American pharma firm under the United Nations Medicines Patent Pool. India’s drugs controller general of India, VG Somani, approved Molnupiravir on Tuesday for restricted emergency use in the country to treat mild to moderate Covid-19 patients.
The drug inhibits the replication of the Covid-19 causing Sarscov-2 virus by introducing errors in its genetic code. It needs to be given early in the infection cycle.
“This launch further enhances the Covid-19 treatment portfolio in BDR’S product basket with the addition of generic Molnupiravir. We are pleased to collaborate with Mankind Pharma to take one step forward in fighting the virus...,” said Raheel Shah, director, business development, BDR Pharma.
The tie-up between Mankind and BDR is a licensing arrangement where production is by BDR Pharma and marketing, selling, promotion, distribution will be done by Mankind.
According to a company statement, Mankind, in partnership with BDR, plans to make Molulife available at mass scale. “A pill for Covid-19 is bound to go miles in strengthening defenses against
Covid-19 battle… will make Molulife available in every nook and corner of the country. The company (is) focusing on providing a range of medicines for the management and treatment of Covid-19 in India,” said Sanjay Koul, senior president, sales and marketing, Mankind Pharma.
Earlier this month, the drug, developed by Merck in collaboration with Ridgeback Biotherapeutics, was approved by the the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and the US Food and Drug Administration (USFDA).
The other Covid-19 pill approved by these countries is Pfizer’s Paxlovid.
According to Union health ministry, Central Drugs Standard Control Organisation received 22 applications for manufacture and market of the drug in the country, of which eight including five applicants of a consortium (total 13) submitted their interim or complete clinical trial report. Considering the emergency and unmet medical need in Covid-19, the Subject Expert Committee recommended permission to manufacture and market be granted, the government said.
“Only when the data seemed satisfactory and all conditions were met that the approval was granted. The regulator wanted to be sure that they were not overestimating the drug’s efficacy that could have led to rise in false expectations,” said a senior government official.
Other Indian companies that received the approval too are readying for a launch of their own versions of the drug, with most likely to go to market in January, 2022.