India has recorded advanced in contraceptive pill by being the pioneer of the world first male contraceptive injection to replace vasectomy. The drug can be used as an effective spacing method; it works for 13years before needing replacement.
The compound is ready but waiting to be authorized by the county’s DCG, the manufacture, sale and distribution of new medical innovation in Indian requires the approval of DCGI, which carries out its own investigation before clearing it.
The Indian Council of Medical Research (ICMR) has successfully completed clinical trial of the world’s first male birth control injection.
ICMR, is the apex body in India for biomedical research. It is financially managed by the Indian government through the department of medical research at the Union ministry of Health and Family Welfare.
Following the successful trial, the drug has being send to Drug Controller General of India (DCGI) for approval.
The injection has duration of 13years after which it become inactive, it was specially formulated to replace vasectomy, the only male sterile method in the world.
Vasectomy is a medical procedure performed to remove a section of the vas deferens; it is usually done in association with prostatectomy with the aim of achieving sterility in male.
The Vas deferens also known as ductus deferens, is a tube in the male reproductive system that transport sperm from the epididymis to the urethra from where it is ejaculated, The removal of this tube during surgery obstructs the flow of sperm into the semen there by preventing it release.
The drug is ready but the approval of DCGI, is pending. 303 candidates were recruited for the extended phase 3 clinical trials which recorded 97.3% success without any side-effects.
‘The product is ready with only regulatory approval pending with the Drug Controller. The trails are over, including extended phase 3 clinical trial for which 303 candidate where recruited with 97.3% success rate and no reported side effects. The product can safely be called the world’s first male contraceptive” Dr RS Sharma, senior scientist with ICMR, who has been leading the trials said.
The US has been working on a similar research but it is still under development.
A publication on UK’s National Health Service, said a trial for the contraceptive was done in 2016 but had to be paused because of side effect such as acne and mood change.
Data from national family health survey, shows that in 2015-2016, about 36% of women choose sterilization as compared to 0.3% men who went for vasectomy.
The birth control injection is a polymer that has to be administered under local anaesthesia in the sperm containing tube close to the testicles (Vas deferens) by a recognized medical professional and it has been on trial since 1984.
“The polymer was developed by professor SK Guha, from Indian institute of Technology in 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, Sharma said
The product called Reversible Inhibition of Sperm Under Guidance (RISUG), is made of a compound called Styrene Maleic Anhydride. Which when injected can last for about 13years
“It is the first in the world from India, so we have to be extra careful about approval. We are looking at all aspect especially the good manufacturing practice (GMP) certification that will not raise any question about its quality’ VG Somani, the drug controller of India said.
‘I did say it will still take about seven months for all the approvals to be granted before the product can be manufactured’, Somani add.
“Non surgical procedures are always preferred over surgical because they are safer and less invasive; more men are likely to opt for it, said Dr. Anup Kumar, head of urology and renal transplant department, Safdarjung Hospital.
According to AR Nanda, former Family Welfare Secretary, Government of India, government need to create awareness and encourage the use of the product to make successful.
‘Two things are needed from the government to make it work; one is to make use of trial subjects for awareness generation among masses about the product and second is to offer higher incentive for people opting for male contraceptive’ he said.