The country’s first male contraceptive Risug appears to have been aborted prematurely. The Health Ministry has claimed that the contraceptive has triggered serious complications during phase-III trials. As a result, the hyped project now stands abandoned.
J.V.R. Prasada Rao, Secretary, Family Welfare, said the Ministry wants the project reviewed ‘‘properly’’. ‘‘There are reports of complications. Trace albumen has been found in the urine of those on whom the drug was tested. ‘‘Scrotum swelling too has been reported. We want samples of 141 subjects, on whom clinical trials have been going on, re-examined,’’ he said.
The Ministry, however, has not provided any evidence. And the experts conducting the trials have written there are no complications in any of the subjects.
The copies of the letters — written by experts at the three hospitals where the trials are on — are with the Indian Express, and they exonerate Risug beyond reasonable doubt.
* Dr Gulshan Jit Singh, head of surgery department, Deen Dayal Upadhyay Hospital, writes to Rao: ‘‘I have gone through the reports of the subjects and did not find significant albumen presence in the post-treatment urine samples. Also, their kidney function tests were within normal limits.’’
* Dr D.P.C. Toor of Rural Medicare Society writes: ‘‘We have not come across a single case of albumen presence.’’
* Dr H.C. Das, project investigator for Risug at Lok Nath Jai Prakash Narayan Hospital, writes: ‘‘I have injected 50 subjects in the trial, and my records indicate in no case is there significant albumen in urine.’’
The development means a big embarrassment for the Ministry that had launched Risug in early June. Health Minister Shatrughan Sinha, however, said the Ministry had not launched it before clinical trials. ‘‘We never said we are introducing it in the market. We only announced that clinical trials were going to start,’’ he said.
If Ministry researcher Professor Sujoy K. Guha is to be believed, officials are protecting the interests of pharmaceutical companies which are in the process of developing male contraceptives.
On charges of the drug triggering scrotum swelling and albumen in urine, he said: ‘‘Scrotum swelling is a temporary side-effect of Risug administration. It subsides in a few days.