According to the Hindustan Times, the Indian Council of Medical Research (ICMR) has completed clinical trials of the injectable male contraceptive, which has been sent to the country’s Drug Controller General of India (DCGI) for approval.
The product, named RISUG (reversible inhibition of sperm under guidance), is made of a compound called Styrene Maleic Anhydride, a polymer that has to be injected under local anesthesia in the sperm-containing tube near the testicles by a medical professional.
The experts involved in the project said the contraceptive can be potent for as long as 13 years and is designed as a replacement for a surgical vasectomy, a procedure which is currently the only available sterilization method for males.
According to RS Sharma, a senior scientist with ICMR who has been spearheading the trials, the contraceptive reported a 97.3 percent success rate after it was tested on over 300 candidates and there were no side effects.
“The product is ready, with only regulatory approvals pending with the Drugs Controller. Trials are over, including extended, phase 3 clinical trials for which 303 candidates were recruited with a 97.3 percent success rate and no reported side-effects. The product can safely be called the world’s first male contraceptive,” he said.
“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.
“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.”
While scientists in the United States had been working on something similar, VG Somani, the drug controller general of India, said the drug would take about six to seven months to be granted approval as it has to be subjected to “extra careful” scrutiny.
“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,” the doctor said.
“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.”