Question : Indian Council of Medical Research

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Indian Council of Medical Research (ICMR) has successfully completed the clinical trials of the world’s first injectable male contraceptive;

(b) if so, the details thereof and the features of the said contraceptive;

(c) whether the necessary regulatory approval from the concerned authorities regarding its use have been taken and if so, the details thereof;

(d) whether the said male contraceptive has some side effects too and if so, the details thereof;

(e) the time by which the said contraceptive is likely to be available in the market; and

(f) the steps taken by the Government to disseminate information and create awareness among common public about this new technology?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a) & (b): Yes. Clinical trails of injectable male contraceptive- Reversible Inhibition of sperm under guidance (RISUG) have been completed successfully. Following are the major features of this contraceptive:
? It is non-hormonal and involves one-time injection procedure which ultimately leads to azoospermia in men.
? The intervention is localized only to vas deferens and there is no detectable interaction with other parts of the body. It therefore differs from hormonal injectable contraceptives, which influence the reproductive system as well as virtually all other parts of the human system.
? It is a minimally invasive procedure.
? A single injection provides contraception for longer duration.
? The method is reversible as has been proved through animal experimentation on primates.
? RISUG has been reported to have no adverse side-effects.
? Contraceptive efficacy of RISUG is 97.3% in terms of achieving azoospermia and 99.02% in terms of achieving pregnancy.

(c): Necessary regulatory approval from the Drug Controller General of India (DCGI), has been sought for its use.
(d): RISUG has been reported to have no adverse side-effects. However, low grade scrotal swelling and scrotal pain, has been observed in some cases, which gradually subsided within a week/two weeks with scrotal support.
(e): The contraceptive is likely to be available in the market after approval of the DCGI.
(f): Research/Programme will be undertaken to study the behavioural changes, communication package intervention to address male participation in contraceptive choices.