HIV Jab for 115 Nations Awaits Nod from Indian Regulators

The revolutionary change that could dramatically impact the prevention of HIV may well hinge on how fast Indian regulators accept the proposal. Gilead Sciences, a US-based company, gave no-royalty licenses to four Indian firms - Dr. Reddy's, Hetero, Emcure, and Mylan - to manufacture lenacapavir, a long-acting injectable, which almost totally 100% stops the HIV transmission.

The injection, which will cost only $40 per person annually, about 0.1% of its original price, delivers six months of protection from just one injection.

This departure is expected to happen by 2027 and could be either stepped up or delayed depending on the regulatory decisions in India. The product will need registration and a certificate from the Indian FDA for exports to 115 low- and middle-income countries.

Several local clinical trials are demanded by experts, in spite of the robust phase-3 data from abroad. This could lead to a delay in timelines. However, there are instances where waivers have been given — India has previously allowed similar exemptions for HIV and Hepatitis C drugs.

Also Read: Aurobindo Pharma to Produce Cabotegravir for HIV in 133 Nations

The breakthrough notwithstanding, access to the drug in India may still be a problem. The National AIDS Control Organisation (Naco) presently depends only on condoms as the sole pre-exposure prophylaxis in its prevention programme. Officials maintain that condoms prevent other STDs as well, in the meantime, experts insist on lenacapavir’s unrivaled effectiveness.

The HIV specialists, Dr. Ishwar Gilada, said, “HIV transmission can now be controlled by almost 100%. This will drastically cut the number of people requiring lifelong treatment.”