First company to get DCGI approval for HIV prevention drug
Drugmaker Cipla has received regulatory approval in India to sell its version of Truvada as a preventive that can be given to healthy people to reduce their risk of getting HIV.
Commonly referred to as PrEP (pre-exposure prophylaxis) in healthcare circles, Truvada, sold by US drugmaker Gilead, is the only medicine globally approved as a preventive in managing HIV. And the recent approval in India as a preventive marks a significant step in HIV prevention efforts, especially in couples where one partner is HIV positive.
Confirming the development, Cipla’s Medical Director Jaideep Gogtay told BusinessLine Cipla is the first company to get an approval from the Drug Controller General of India (DCGI) to sell its version of the drug (Tenvir EM) as a preventive. The drug has been in use in India for about eight years now, but only for the treatment of people with the HIV infection, he said. The big difference now is that it is used to prevent infection in healthy people.
“It has added a big new weapon in the fight against the HIV epidemic,” Gogtay said. Cipla’s drug is priced at ₹2,200 for a month.
Treatment vs prevention
Gogtay added that the medicine, sold only on a doctor’s prescription to healthy uninfected people in the high risk, reduces an individual’s risk of getting infected by as much as 90 per cent (if taken everyday).But that’s in addition to other safe practices that individuals in high-risk categories are required to follow.
For Cipla, the first step was to get the drug approved as a preventive in India. “Now we go to the other countries,” Gogtay said. Cipla already sells the drug in South Africa for treatment purposes.
Industry experts point out that generic companies such as Mylan, Hetero and Emcure also sell the drug, but for treatment. None has got DCGI approval to be used as a preventive, pointed out Gogtay.
With the added indication, Tenvir EM can now be used by private doctors in “sero-discordant” couples (where one partner is HIV positive). But on a larger level, it can also be used as part of the national public health programme to bring down new HIV infections, estimated at about 80,000 in India.
Explaining the significance of the drug as a preventive, YRG Care’s Chief Medical Officer, N Kumarasamy, said that late last year the WHO had issued guidelines on PrEP. While the national programme here looks at getting treatment to everyone who needs it, the NACO will also be planning on how to introduce PrEP into the programme to control new infections.