Skip to main content

The Professor Who Had to Spend Half His Life to Make the Drug India Needs

Sujoy Guha has spent 37 years trying to realise Risug, a long-term use reversible male contraceptive – itself an unusual thing. It should have come to be more than a decade ago.


verything is still the same.
Sujoy Kumar Guha, professor emeritus at IIT-Kharagpur, wakes up around 11 am, reads the paper and thinks of what science can offer as solutions to the big problems of the day. In the evenings he runs his PhD students off their feet with constant demands, yet somehow leaves them itching to do something worthy of him. Around midnight, he takes off for a jog around the handsome campus with a leather belt wrapped around his right palm to fend off the stray dogs. He is still the slight, sprightly, soft-spoken man he was. He still answers questions after a few seconds' silence with a lateral anecdote. He still describes most persons as a "very nice man".
Everything is much the same as in 2002, when the then health minister C.P. Thakur had announced the imminent launchof Guha's drug molecule Risug, a reversible male contraceptive. But the clinical trials were then halted on the charge that Risug was toxic. It took five years for the professor to restart the trials. In 2016, Risug is once again almost ready for its launch at the tail end of the phase III clinical trials that have been "99% successful", according to the ICMR. Only, he was 62 then, he is 76 now. And in the past 14 years have been spent in proving what he had already proved successfully.
"We have completed testing on 282 volunteers in five centres across India, and zero side-effects and difficulties have been reported," said Dr R.S. Sharma, head of Reproductive Biology and Maternal Health at the Indian Council of Medical Research (ICMR), in a telephone interview. "I am waiting to reach 300 volunteers and then I will submit Risug for approval to the Drug Controller General of India. It is very unusual, in fact. I have worked on Risug for 25 years and not a single problem has been reported so far."
ᐧ

Comments

Post a Comment

Popular posts from this blog

Indian government outlines policies on drug pricing to favor poorer patients, and increase clinical trials

The Indian government is looking to review the existing drug price control measures in order to make medicines more affordable in the country, and at increasing the number of clinical trials taking place in the country, reports The Pharma Letter's India correspondent. In a parallel move, the Health Ministry is also preparing a framework for public private partnership to tackle the menace of non-communicable diseases in the country, In a move that could potentially result in affordable Medicare and health security moving to a larger section of the population, the government is considering a rash of policy measures in favor of poor patients. Talks are also on in government circles to abolish clinical trials on proven drugs that have been approved and marketed for at least two years in the European Union, United States, UK, Australia, Canada and Japan. A draft proposal in this regard has been prepared by the Health Ministry. If instituted, it would reduce the time taken to introduce n...
Post a Comment
Read more

The polypill: Medicine's magic bullet

The capsule costs pennies, contains a simple cocktail of medicines, and halves the number of strokes and heart attacks. Doctors want to hand it out in the first mass medication for the middle-aged in Britain. So why are the big drug companies so uninterested? The magic bullet, containing five medicines in a single capsule, sharply reduced cholesterol and blood pressure levels and has the potential to "halve cardiovascular events in average middle-aged individuals", the researchers say. The finding is a major boost for a medication with huge potential against the worldwide epidemic of heart disease and stroke. Doctors say that, if further trials prove successful, all men aged over 50 and women aged over 60 should be offered the pill in what would be the first example of mass medication for the middle-aged in Britain. Yet no Western pharmaceutical company has shown interest in developing the so-called polypill because it does not promise big profits. It would sell for pennies b...
Post a Comment
Read more

Registration of herbal trials in CTRI is not mandatory

A trial patient visited the site complaining breathlessness and tachycardia. The investigator advised hospitalization but as subject could not afford the expenses, he refused for admission. Is this an SAE because investigator advised hospitalization? G Praveen Kumar. If the patient was not hospitalized, it does not fall into SAE criteria of hospitalization. However, it appears from your mail that the PI felt that the event was serious enough to admit the subject for treatment. This makes it an “important medical event." As per ICH E2A such event also are considered serious. See the ICH E2A excerpt below: Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the patient or may require intervention to prevent one of the other outcomes listed in the defin...
Post a Comment
Read more