The monitoring committee of Indian Council of Medical Research (ICMR) has extended the Phase III restricted clinical trials of 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, upto April 2003. The Monitoring Committee of ICMR has been constituted to oversee the progress of trials of RISUG.
The results of the analysis of the 141 subjects recruited and followed upto 6 months will be completed in December 2002, it is learnt.
In a recent review meeting of the monitoring committee called by the Union Minister for Health & Family Welfare, the minister was informed that the research on RISUG has not be stalled and the restricted Phase III clinical trial which expired on March 2002 has been extended upto April 2003. The meeting attended by Secretary (FW), Secretary (Health), DGHS, DG (ICMR) and Dr. Guha also ensured that funds would be provided for toxicological studies including genotoxicity and mutagenecity.
It may be recalled that the approval for restricted Phase III clinical trial for proving efficacy of injectable male contraceptive (styrene maleic anhydride acopolynus dissolved dimethyl sulpoxide) developed by IIT Delhi was given in March 1999 for a period of three years with funding from the Department of Family Welfare by DCGI.
The discipline of Phase III clinical trials requires that the researcher himself should not directly associate with the conduct of trials so as to maintain total objectivity. Accordingly ICMR has been designated as the coordinator and the trials are carried out in LNJP Hospital, Deen Dayal Upadhay Hospital and Rural Hospital, Mehrauli, New Delhi. The progress of the trials is reviewed by a Monitoring Committee. The Monitoring Committee met in June 2002 to review the progress of 141 subjects recruited and 63 subjects who have been followed up for 6 months. Preliminarily analysis was presented on the 63 subjects.
The Toxicological review panel of ICMR for reversibility study of RISUG also had a meeting in June 2002. The Committee observed that dimethyl sulphoxide used for solvent of styrene maleic anhydride is a strong detergent and damages kidney, seen as albumin in urine causing sub clinical glomerulitis. Since it is known for its toxicity the side effects are to be monitored.
The Monitoring Committee has recommended that drug dossier as per Schedule "Y" requirements should be prepared and evaluated before taking up more cases for clinical trials. Accordingly Dr. Guha was advised to follow the recommendation of the Toxicological Review Panel to review the 141 subjects recruited and allow analysis done.
It should be noted that pharmabiz had recently reported that international pharmaceutical companies have shown interest in commercializing the product, which, reportedly, could be priced at Rs.100 for indigenous market and $500 for overseas markets.
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.