The Indian Council Of Medical Research (ICMR) has announced the discovery of the world’s first male contraceptive which comes in the form of injections.
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 injection has been named ‘Reversible Inhibition Of Sperm Under Guidance (RISUG).
The contraceptive is set to be available in six months.
The injections help to prevent unwanted pregnancies and it is awaiting regulatory approvals for mass production.
The drug has completed clinical trials and has been sent to the Drug Controller General of India (DCGI) for approval.
Dr RS Sharma, who is one of the senior scientists with ICMR has been super heading the trials.
Sharma said:
“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,”
The drug is designed as a replacement for surgical vasectomy which was the only male sterilization method available in the whole world until now.
The contraceptive has a shelf life of 13 years, after which it loses its potency.
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The contraceptive is a polymer that has to be injected under local anaesthesia into the Vas deferens which is close to the testicles.
Sharma said:
“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,”
“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,”
“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 practise (GMP) certification that won’t raise any questions about its quality,” said VG Somani, who is the drug controller general.