The Indian Council of Medical Research (ICMR) has successfully completed clinical trials of the world’s first injectable male contraceptive, according to researchers involved in the project, reports BET.
“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 a 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, according to The Hindustan Times.
The ICMR, a government-funded biomedical research agency, has created this first-of-its-kind male contraceptive as a replacement for surgical vasectomies. Currently, this is the only method for male sterilization that exists today. It could be made available in seven months if approved and will reportedly last around 13 years.
“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 VG Somani, the drug controller general of India.
“I’d say it will still take about six to seven months for all the approvals to be granted before the product can be manufactured,” said Somani. The manufacture, sale, and distribution of new medical innovation in India requires approval from DCGI, which conducts its own checks before clearing it.
The contraceptive is called reversible inhibition of sperm under guidance (RISUG) and is made up of a polymer that is injected into the tubes that carry sperm from the testicles known as the vas deferens.
“Two things are needed from the government for it to work; one is to make use of the trial subjects for awareness generation among masses about the product, and second is to offer higher incentives for people opting for male contraceptives,” says AR Nanda, former family welfare secretary, Government of India.
The Hindustan Times announced it on their Twitter account, “The contraceptive is designed as a replacement for surgical vasectomy, which is the only male sterilization method available in the world.