The world’s first injectable male contraceptive, that will stop unwanted pregnancies, is ready and is awaiting regulatory approvals for mass production, the Indian Council of Medical Research (ICMR) said.
The ICMR said it has completed clinical trials of the drug, which has now been sent to the Drug Controller General of India (DCGI) for approval.
“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.
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.
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.
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 (RISUG), 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,” said Sharma.
“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.