Indian regulatory system needs strengthening

Indian regulatory system needs strengthening
Highlights

As the clinical trial industry is facing a 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.

The Indian drug regulatory system is very weak when compared to the US FDA, in the clinical trials segment. The rules and protocols should be amended and strengthened to prevent unscrupulous entities from taking advantage of any loopholes in the regulations

As the clinical trial industry is facing a 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 NS Viswanathan, Chief Financial Officer, Neuland Laboratories Ltd, “The Indian drug regulatory system is very weak when compared to the US Food and Drug Administration (FDA), particularly in the clinical trials segment. The rules and protocols should be amended and strengthened to prevent unscrupulous entities from taking advantage of any loopholes in the regulations.”

“Unlike in the western world, Indian researchers and clinical research organisations in most cases 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 challenge the existing system. Also, the regulatory system should be reformed and loopholes plugged to make it more transparent and accountable,” Viswanathan said. The industry is facing a lot of resistance both from rights groups and from regulators. During the past two years the Drugs Controller General of India (DCGI) has not given more than 50 approvals for clinical trials in India.

“In the wake of international regulators like US FDA and European Union (EU) issuing warnings and blacklisting 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,” the CFO concluded.

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