National

First injectable male contraceptive developed

By Gargi Parsai

NEW DELHI MAY 28. India has successfully developed a male injectable contraceptive — RISUG — which will be available on doctor's prescription within six months after the current multi-centric Phase III trials are over. The contraceptive, considered the first of its kind in the world, is much in demand even in countries abroad. Besides Canada, the United States, Germany and South Africa have evinced interest in the drug-based single shot contraceptive, which is reversible.

Sujoy K. Guha, professor, Biomedical Engineering, Indian Institute of Technology, who developed the injectable over 25 years in collaboration with the Indian Institute of Medical Research and the All-India Institute of Medical Sciences, told The Hindu that the contraceptive had been patented in India, the U.S., Bangladesh, Malaysia, Thailand, and "almost in China''.

A pilot joint venture has been set up for the development of the product with the Indian Drugs and Pharmaceutical Limited, Dr. Guha said and added that talks were in an advanced stage with two international drugs manufacturing companies abroad.

In India, the entire package, including the drug along with a specially designed syringe, was likely to cost Rs. 100. Abroad, the price would be fixed at $ 500.

"This is a proud moment for the nation,'' the Union Minister for Health and Family Welfare, C.P. Thakur, said here while officially announcing the introduction of the injectable. "Finally a new contraceptive for males has been designed indigenously. It is now time to draw the attention of men to their social responsibility in terms of the significant role they can play in population stabilisation by adopting this minimally invasive, non-toxic, reversible contraceptive. Undoubtedly, a marriage of science, technology, medicine and biology has resulted in this remarkable development.''

RISUG — short for Reversible Inhibition of Sperm Under Guidance — is only once injected into the scrotum of the male resulting in destruction of the fertilising ability of the sperms without any adverse impact on male sexuality. Moreover, reversibility does not require surgery. RISUG acts by generating small electrical charge on interaction with the body fluids and alters the normal negative electrical charge on the sperm leading to enzyme changes and disintegration of sperms. The only side effect noticed initially in some subjects was a slight swelling of the scrotum for about three weeks.

The injection is best for under-40 males, Dr. Thakur said.

The Drug Controller of India's approval of Phase I and Phase II clinical trials has confirmed the safety and efficacy of the injectable. The data of Phase III trials on 132 subjects has been submitted to the Ministry of Health and Family Welfare. Extended Phase III trials are now on in the Lok Nayak Jayaprakash Hospital, the Deen Dayal Upadhayay Hospital, the Mehrauli Medical Centre, all in Delhi and the Jaipur Medical College.

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