India All Set to Create World’s First Male Contraceptive Injection, Approval Awaited
Representative Image (Photo courtesy: AFP)
For years, sterilization is considered as the only male contraceptive process in India. However, the Indian Council of Medical Research (ICMR) is all set to introduce another contraception method for males. The Indian Research Institute has, recently, completed the successful clinical trials of the world’s first injectable male contraceptive. This can be a breakthrough discovery in male contraception methods.
As reported by Hindustan Times, the contraceptive will stay effective for 13 years before losing its potency. However, it is better and practical alternate for surgical vasectomy, the only male sterilisation method known to the world. For now, the injectable male contraceptive has been sent to the Drug Controller General of India (DCGI) for receive the approval.
Dr RS Sharma, senior scientist with ICMR, told the daily, “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.”
India is not the only country working on devising such a method. The researchers in the US have been working on a similar contraceptive. However, the project is still under development.
As per the data received from the National Family Health Survey-4 (2015-16), 53.5% of couples in India use some method of contraception or spacing methods. However, permanent methods like sterilization have been more common, as compared to others.
Sharma explained about the new method, “The polymer (contraceptive) 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.”
The product is known as reversible inhibition of sperm under guidance (RISUG). It is made of a compound called Styrene Maleic Anhydride and is effective for 13 years once injected.
On the other hand, VG Somani, the drug controller general of India, told the daily, “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.”