Breach of clinical trial norms could invite ten years in jail, under the new guidelines being framed by the government. Those who follow the rulebook religiously have nothing to fear, but the unscrupulous agencies had better review their operations.
Companies have been going berserk in their hurry to launch new variants of drugs. Not just clinical trials, which deal with new experimental drugs, but also the bioavailability and bioequivalence studies required to test existing drugs before they can be allowed to be marketed often fall afoul of the regulatory norms laid down.
Indeed, clinical trials in India are a silent bomb going completely uncontrolled and nobody knows the extent of damage that it can cause.
In loud moves months ago, drug regulatory bodies had spoken of removing hundreds of irrational combinations from the Indian market. If these combinations have found their way into the market and are now investigated to be inefficacious, how is it that the government approved the drugs in the first place? Where are the bioequivalence studies conducted against standard drugs? Are these combination drugs used anywhere else in the world? What are the trial protocols for such drugs before they are allowed to be present on the shelves? These are some uncomfortable questions the government agencies need to deal with before framing laws to discipline the clinical trials industry and plugging news in dailies.
Investment firms tend to talk up the potential of the clinical trials industry in India, but our systems may not be ready yet with fool-proof patient protection clauses for the allowance of trials.
Though a lot has been said on the fair intent of the new Drug Controller General of India, Dr Surinder Singh, he and his officers have to deal with companies that are used to finding shortcuts and methods that may not be seen as ethical practices.
In the recent past, a few instances of alleged deviation from standard clinical trial practices have come to light. The trials were for vaccines and were conducted on behalf of well-known multinational companies. These are big names in the pharmaceutical world and one would normally not expect loopholes from any of them. It cannot be accidental either.
The move to impose a ten-year imprisonment clause shows the government’s resolve to put in place adequate safeguards for trial candidates and ensure that the flow of future trials is in accordance with international norms, rather than just harp on the speed with which a trial is completed.
Though there are several provisions for due compensation if a trial goes wrong, adverse reactions seldom come to light in India.
According to government websites, hundreds of trials are being conducted in India and the numbers are rising rapidly, but one hardly finds anyone pointing at the flaws.
Awareness levels are abysmally low even in the cities. Of the rural areas, therefore, the less said the better.
Taking advantage of the rush for clinical trials, training institutes have also cropped up at every street corner. It has to be remembered that clinical trials are not a vocational course and scientific skills are required to conduct world class trials.
It is imperative that the regulators keep a watch on the goings on.
Pillman is an executive closely linked to
the global pharma industry. d
