Women may cease to worry about pregnancy and how to prevent it, as the world’s first injectable male birth control may finally be on its way to approval in India
The Indian Council of Medical Research has successfully completed clinical trials of the world’s first injectable male contraceptive, which has been sent to the Drug Controller General of India for approval, Hindustan Times says, citing 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,” it adds.
While the trials lasted, 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 a senior scientist with ICMR, Dr. RS Sharma, who led the researchers.
Explaining further, Sharma said, “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 after exhaustive trials,” said Sharma.
“The product, called reversible inhibition of sperm under guidance, is made of a compound called Styrene Maleic Anhydride.
“It is effective for at least 13 years once injected. In clinical studies on mice, it has been proven to be a reliable spacing method, and we will be initiating human studies soon to prove that in humans also, it can be used as an effective spacing method,” he added.
“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 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 Sonami.
The manufacture, sale and distribution of new medical innovation in India requires approval from DCGI, which conducts its own checks before clearing it.