India closer to world’s first male contraceptive injection

NEW DELHI: The Indian Council of Medical Research (ICMR) has successfully completed clinical trials of the world’s first injectable male contraceptive, which has been sent to the Drug Controller General of India (DCGI) for approval, according to researchers involved in the project.

The contraceptive is effective for 13 years, after which it loses its potency. It is designed as a replacement for surgical vasectomy, which is the only male sterilisation method available in the world.

“The product is ready, with only regulatory approvals pending with the Drugs Controller. The trials are over, including extended, phase 3 clinical trials for which 303 candidates were recruited with 97.3% success rate and no reported side-effects. The product can safely be called the world’s first male contraceptive,” said Dr RS Sharma, senior scientist with ICMR, who has been spearheading the trials.

ICMR is the apex body in India for biomedical research. It is funded by the Indian government through the department of medical research at the Union ministry of health and family welfare.

Researchers in the US were working on a similar contraceptive. According to an article published on the website of the UK’S National Health Service, a trial for the male contraceptive was conducted in 2016 but it had to be stopped because of side effects. “Side effects like acne and mood changes were common,” it said.

In India, 53.5% of couples use some method of contraception or spacing methods, with permanent methods like sterilisation being the most popular, shows data from the National Family Health Survey-4 (2015-16). Around 36% of women opt for sterilisation as compared to 0.3% men going for vasectomy.

The contraceptive is a polymer that has to be injected under local anaesthesia in the sperm-containing tube near the testicles (vas deferens) by a registered medical professional. “The polymer was developed by Prof SK Guha from the Indian Institute of Technology in the 1970s. ICMR has been researching on it to turn it into a product for mass use since 1984, and the final product is ready,” said Sharma.