Male contraceptive injections for commercial sale could be on the market within six months.
The Indian Council of Medical Research (ICMR), a biomedical research body, completed their own trials on the groundbreaking product, but it now must be sent to the Drug Controller General of India (DCGI) for final approval.
The contraceptive, which they’re calling ‘reversible inhibition of sperm under guidance (RISUG)’, will remain effective for 13 years before losing its potency, serving as a replacement for a surgical vasectomy.
The product is made up of a compound, Styrene Maleic Anhydride, that inhibits sperm production.
It works via an injection issued by a health professional under local anesthesia into the vas deferens, a tube near the testicles.
“The product is ready, with only regulatory approvals pending with the Drugs Controller,” Dr RS Sharma, senior scientist with ICMR, told local news outlet Hindustan Times.
“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,” he said.
“The product can safely be called the world’s first male contraceptive.”
While Sharma is optimistic, rigorous quality testing means it won’t be available for a minimum of six months.
VG Somani, the Drug Controller General of India, says it may “take about six to seven months for all the approvals to be granted before the product can be manufactured.”
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“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,” said Somani.
While a surgical vasectomy is currently the only approved method of contraception for men, according to a 2015 study, more than 2.5 million Australian women between the ages of 18 and 49 (47.9%) were using some form of contraception.
At the time, the oral contraceptive pill was the most popular method with just less than half (44.5%) of Australian women who used contraception reported taking it as their primary method of birth control.
In the video below: In March 2019 a new male contraception pill passed its first safety test but was not expected to hit the shelves for 10 years