MANKIND LIKELY TO PARTNER RDIF TO MARKET SPUTNIK V IN INDIA
As Russian Covid-19 vaccine Sputnik V nears entry into the Indian market, one of the largest drug firms in the country, Mankind Pharmaceuticals, is likely to partner the Russian Direct Investment Fund (RDIF) for distributing it in India.
According to sources, Sputnik V may be priced ~500 per dose when it is commercially available. The Centre and RDIF, however, will negotiate prices at which the government will procure the vaccine for the national Covid immunisation drive.
According to sources close to the development, talks are in advanced stages between Mankind Pharma and RDIF to sign a partnership for distribution of the vaccine in India.
An announcement is likely soon.
Mankind Pharma did not comment on the development and an email sent to RDIF remained unanswered.
“This would be a distribution partnership for taking the vaccine to remote corners of the country. Mankind has a strong distribution network in the hinterland,” said a source.
At present, drug regulator Drugs Controller General of India (DCGI) has granted “restricted emergency use” authorisation to two vaccines – Covishield and Covaxin. This does not allow the makers to sell these vaccines commercially. The government procures the vaccine from them.
The marketing and distribution partnerships will come into force after the commercial sale of vaccines is allowed.
At present RDIF has a tieup with Hyderabad-based Dr Reddy’s Laboratories (DRL) for conducting bridging clinical studies in India (which have been concluded). The pact is also for distributing and marketing the vaccine in India. DRL is also helping RDIF in securing the Indian regulator’s authorisation for its vaccine in India.
It has already applied for an emergency use authorisation before the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).THE SEC has sought detailed insights on immunogenicity (desired
immune response triggered by a vaccine), serious adverse events following vaccination, comparison of immunogenicity data between Indian and Russian trials apart from a cold chain management plan.
The SEC is meeting on Monday to review DRL’S application.
Sputnik V has been registered in 59 countries globally with a total population of over 1.5 billion. Efficacy of Sputnik V is 91.6 per cent.
RDIF has tied up with several manufacturing partners in India to produce the vaccine on a large scale for both the Indian and international markets. DRL had earlier indicated that the 250 million doses have been lined up for India.
Total manufacturing capacity lined up with several partners in India is over 850-900 million doses annually. This includes Hetero, Gland Pharma, Virchow Group, Stelis Pharma and Panace Biotec, among others.
According to sources, more players, including Serum Institute and Shilpa Medicare, are also likely to be manufacturing partners and talks are on for this. The total capacity for making Sputnik V in India can thus cross one billion doses annually, much ahead of the other vaccine candidates.
Sputnik V requires a minus 18-20 degree Celsius cold chain to remain stable. Work on a lyophilised (or freeze dried) version of the vaccine is going on. This version can remain stable at 2-8 degree Celsius.