The world's first injectable male contraceptive, Reversible Inhibition of Sperm Under Guidance (RISUG), developed by Prof. S. K. Guha, head, Biomedical Department, Indian Institute of Technology (IIT), Delhi, has completed phase 3 trials. The report of the human trials on 132 subjects, which is already submitted to the drug control general of India (DCGI) and the Union Ministry of Health and Family Welfare, has showed highest success and safety rates, it is learnt.
The injectable contraceptive, which is currently taken to extended trails at multiple centers, is awaiting marketing approval from the DCGI shortly.
The Phase I and Phase II clinical trials already approved by the Drug Controller General of India (DCGI) has however confirmed the safety and efficacy. The extended Phase III trials are going on in the Lok Nayak Jayaprakash Narain Hospital, the Deen Dayal Upadhayay Hospital, the Mehrauli Medical Centre, all in Delhi, and in the Jaipur Medical College, Jaipur, sources from IIT Delhi said.
In the meanwhile, according to sources in IIT, a pilot venture has been set up for the manufacture of the product within the Indian Drugs and Pharmaceutical Ltd (IDPL). And, the negotiations are also going on with two international pharmaceutical companies to commercialize the product. Canada, United States, Germany and South Africa have also shown interest in the drug based single shot contraceptive.
In India, the entire package including the drug along with a specially designed syringe will be priced at Rs.100 while in the overseas the price would be fixed at $500. The injection is best of under 40 males.
The research to develop the male contraceptive was initiated at the Biomedical Department of IIT, Delhi, in 1972. Over 100 scientists have contributed to this painstaking research.
The USP of RISUG is that unlike vasectomy it becomes effective the moment it is injected into a male apart from being a single intervention technique. Vasectomy becomes effective after almost three months. Further, reversing vasectomy is a difficult process.
RISUG is only once injected into the scrotum of the male resulting in destruction of the fertilizing ability of the sperms without any adverse impact on male sexuality. It 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 the sperms. The only side effect noticed initially in some subjects was a slight welling of the scrotum for about three weeks.