As the clinical trial industry is facing lot of resistance in India, Industry experts are of the view that the Indian regulatory system should undergo massive reforms to contain unethical practices in clinical trials and should pave way to open up at least 10 per cent of global clinical trials in the country.
According to N S Viswanathan, chief financial officer, Neuland Laboratories limited, the Indian drug regulatory system is very weak when compared to the US FDA, particularly in the clinical trials segment, the rules and protocols should be amended and strengthened so that it should not give any chance for the unscrupulous and rouge elements to take advantage of any loopholes in the regulations.
“Unlike in the western world, in most cases the Indian researchers and clinical research organisations do not stick to their actual experimental results. They tend to manipulate it and try to match it with the standard values. Because of this kind of mindset we are not able to invent new things. We need to change our mindset and should believe in ourselves and should be able to challenge the existing systems. At the same time the Indian regulatory system should also be reformed and all loopholes should be plugged to make it more transparent and accountable,” said the CFO.
Though the country has a huge potential for clinical trial industry in India, the industry is facing lot of resistance both from rights groups and from the regulators. Not just that, because of a few rouge elements involved in the clinical trial industry and the media is also responsible for blowing the issue out of proportion, the industry has lost lot of opportunities in the drug discovery. During the past 2 years the DCGI has not even given more than 50 approvals for clinical trials in India. It is right time that India needs to streamline its regulations and should pave way to open up at least 10 per cent of global clinical trial market in the country.
“We should follow what is best in the world. Our regulations are driven by Supreme Court rather than science and its essence. The regulatory system needs to be strengthened and needs to incorporate ways and mechanisms to find black sheeps and rouges in the clinical trials. Particularly, there is a need for incorporating right compensation for the subjects on trial. Transparent regulatory system should evolve and each and every data pertaining to the subjects should be made available and should not give scope for any manipulation,” said the CFO.
In the wake of international regulators like US FDA and EU issuing warnings and blacklisting the pharmaceutical units in India, it is high time that Indian regulatory system needs to be strengthened and should bring in more regulatory reforms in the drug control administration on the lines of international standards.