The jab, which could be available within six months, has been filed with the national Drug Controller General of India for final approval. The injection has the ability to remain effective for 13 years.
“The product is ready, with only regulatory approvals pending with the Drugs Controller,” said Dr RS Sharma, senior scientist with Indian Council of Medical Research, speaking to the Hindustan Times.
“The trials are over, including extended, phase 3 clinical trials for which 303 candidates were recruited with 97.3 per cent success rate and no reported side-effects. The product can safely be called the world’s first male contraceptive.”
How does it work? The contraceptive operates by injecting a polymer called Styrene Maleic Anhydride into a sperm-containing tube near the testicles. The substance injected prevents sperm production.
While the injection might be the first male contraceptive available in the world, the birth control is seen as a long-term alternative to a vasectomy.
“It’s the first in the world from India so we have to be extra careful about approval. We are looking at all aspects, especially the good manufacturing practice (GMP) certification that won’t raise any questions about its quality,” adds VG Somani, the Drug Controller General of India.
“It will still take about six to seven months for all the approvals to be granted before the product can be manufactured."
In the last two years, scientists have been trying their best to come up with a substitute for condoms, including a contraceptive gel that contains a testosterone halting chemical called progestin. The gel is designed to enter the bloodstream, lowering testosterone enough to stop the production of sperm in the testes, whilst simultaneously release a synthetic testosterone replacement to counter any hormonal imbalances.