Researchers at the Indian Medical Research Council said the agency has successfully completed the world’s first clinical trial of an injectable male contraceptive pill and has been sent to the Indian Drug Administration for approval, the Times of India reported Thursday. Reported that the pill was designed to replace vasectomy, valid for 13 years, after the failure. It is said that vasectomy is the only available method of male sterilization in the world.
“The product is ready and only needs to wait for approval from the drug regulator, ” said Sharma, a senior scientist at the Indian Medical Research Council who led the study. The trial has been completed and includes an extended Phase III clinical trial. We recruited 303 volunteers with a 97.3% success rate with no side effects reported. ”
Data from the National Household Health Survey (2015-2016) show that 53.5 per cent of Indian couples use contraception or birth control, with permanent methods such as sterilization the most popular. About 36 per cent of women opted for sterilization, while 0.3 per cent of men opted for a vasectomy.
“This is the world’s first from India, so we have to be very careful when approving. We are doing research on all aspects, especially good manufacturing practices, so that there is no question about its quality,” said Somani, head of India’s Drug Administration.
“I would say that it will take six to seven months for all approvals to take until the product can be produced, ” Somani said. “In India, the production, sale and distribution of new medical products requires the approval of the Drug Administration.
Doctors say men will be more popular for injecting birth control pills than vasectomy.
“Non-surgical treatment is always more popular than surgical treatment because non-surgical treatment is safer and less invasive. More men may choose it,” said Annap Kumar, director of urology and kidney transplantation at Safdaron Hospital.
Experts say male contraception can work well in India if the government is actively promoting it.
“The government needs to have two conditions: to raise public awareness of the product through trials, and to provide higher incentives for people who choose male birth control pills,” said Nanda, a former minister of family welfare.