Results of Trials on Injectible Male Contraceptive to Be Unveiled in India in April

by Gopalan on  March 28, 2008 at 12:24 PM General Health News
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Results of Trials on Injectible Male Contraceptive to Be Unveiled in India in April
The results of trials on an injectible male contraceptive will be unveiled in April, authorities of the Indian technical institution behind the project have said.

It is an invention of Sujoy Kumar Guhaof the Indian Institute of Technology, Kharagpur and is based on a technique called Reversible Inhibition of Sperm Under Guidance, (RISUG).

It involves an injection into the vas deferens, the vessel through which the sperm moves before ejaculation. In a matter of minutes, the injection coats the walls of the vas with a clear gel prepared through irradiation.

Dr.Guha says it works, is non-surgical, and is long-lasting, a single 60 mg injection can be effective for at least ten years. It is convenient, one doesn't have to run around to looking for contraceptives when in the throes of passion and has few side effects.

It is also reversible, the vas deferencs can be flushed.

Speaking to Business Standard, Manoj Mondal, senior administrative officer, finance and project management, sponsored research and industrial consultancy (SRIC) cell, IIT-Kharagpur, said, "We have been trying to develop a non-surgical male contraceptive for ten years now.  A single 60 mg injection can be effective for at least 10 years.

A single dose, which may cost the manufacturer Rs 50, is expected to be marketed at close to Rs 200. This innovation will be made public along with around 50 others patented by the institute on April 5-6.

The institute will host IndAc 2008, a two-day curtain-raiser, to showcase these innovations to pharma majors, corporate entities and entrepreneurs.

"We plan to either sell the technology to corporates and entrepreneurs or get into a revenue-sharing model for their use. All our innovations are ready for commercialisation," Mondal said.

"Currently, we are testing the contraceptive on humans in Pune and Kolkata. We will disclose the results and a complete report during IndAc 2008," he added.

Way back in October 2002, India's Ministry of Health had aborted the clinical trials on the contraceptive following reports of albumin in urine and scrotal swelling in Phase III trial participants.

The ICMR noted that dimethyl sulfoxide used as a solvent for the injection is known to cause kidney damage. Although the ICMR has reviewed and approved the toxicology data three times, some United States researchers say that the studies were not done according to recent international standards.

RISUG was resubmitted for a new round of tests at a US lab, and was approved as non-mutagenic in July 2005.

Subsequently in March 2006, the Indian Council of Medical Research (ICMR) announced that Phase III trials of RISUG could resume at 4 centers around India. And in January last its Deputy Director-General R.S. Sharma had said the trials were being extended to six other states.

Meantime the Kharagpur IIT is promising to announce the results of its trials and is also going ahead with its marketing proposal.

Though the price has not been fixed, officials say it will be a multi-crore deal.

The Centre spent at least Rs 10 crore on the research. "Naturally, the price of acquiring the technology will be steep. We had foreign companies lining up, but we turned them down because we want an Indian company to buy it," said Partha Pratim Chakra-borty, dean of the institute's Cell for Sponsored Research and Industrial Consultancy.

Technologies to be showcased include a nano particle drug against prostate cancer. The institute is looking for industry partners to engage in collaborative research to take this forward.

The institute has also invented an artificial substitute for a human heart, made of polymer and is powered by battery. The innovation is ready for clinical trials.

Other innovations include a heart sound analyser, a knee joint simulator, packaged coconut water, technology to manufacture curd powder, a device for cryogenically freezing fish, meat, fruits and vegetables and a device for cryogenic grinding of spices, vegetables and foodgrain.

Source: Medindia

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