Strict prosecution laws needed by India to fix Drug Regulatory System : Dinesh Thakur
The whistle blower of the top Indian drug maker Ranbaxy (now part of Sun Pharma), Mr. Dinesh Thakur, who is famous for highlighting data manipulation issues, said that the country needed strict criminal prosecution against suppliers of substandard drugs, a nationwide product recall system and more teeth to the central drug administration.
Thakur shared these views as part of his submissions to the health ministry, which is engaging with stakeholders for a comprehensive overhaul of rules governing the Indian pharmaceutical industry.
In his 123-page report titled ‘Fixing India’s broken drug regulatory framework’, Thakur and his co-author and lawyer T Prashant Reddy, suggested greater empowerment for the central administration by amending certain legal provisions like Drugs and Cosmetics Act’s Rule 69, which gives states the power to grant or renew licences to make and sell most drugs.
Thakur noted that the provision has led to poor co-ordination and inconsistent application of the law. This has also led to different standards of enforcing the law across states, poor inter-state co-ordination while recalling substandard drugs and lack of uniformity in the suspension of a manufacturer’s licence, according to him.
Despite past recommendations
from various committees and drug policies to centralise the licensing powers under a national drug regulator, the current system still separates these powers, Thakur’s report indicated.It pointed to the recommendations of one such expert panel, adding that the Centre would have amended the rules 12 years ago if it was really serious about implementing these recomendations.
Notably, in March this year, Thakur had moved a public interest litigation in the Supreme Court against the Drug Controller General of India to bring into focus alleged regulatory loopholes that led to the supply of substandard drugs. The PIL was dismissed.
To make India’s drug regulation more effective, Thakur also suggested using a statistical method to draw drug samples for testing across all states and stricter legal action against companies with substandard products.
While the D&C Act includes provisions to prosecute suppliers of substandard drugs, he noted only a very small percentage of these cases actually reached the stage of prosecution.
This, he said, was because of guidelines introduced in 2008 by the country’s Drugs Consultative Committee (DCC)—a statutory body consisting of representatives of all state drug controllers, DCGI and the Centre.
According to Thakur and Reddy, these guidelines are “illegal and unconstitutional” because they bypass the binding standards recognised by the Act and dilute the requirements to initiate criminal prosecution in all cases of quality breaches.
DCC’s guidelines only allow criminal prosecution when the drugs are found to be spurious or counterfeit, while other types of substandard drugs would merely lead to the suspension of the manufacturer’s licences, they argued.
Even in cases of grossly substandard drugs, DCC states that prosecution should be used “judiciously” where criminal intent or gross negligence is not established—an aspect that is completely contrary to Section 27 of the Act, which imposes a strict liability standard on all defendants regardless of their intentions, they said.
In another point, Thakur highlighted the need for compulsory bioequivalence studies and stability testing for all generic drugs that pharma companies intend to sell here. The report also pushed for a mechanism for the nationwide withdrawal of a bad batch of drugs known to have failed a quality test in a particular State. According to Thakur, this is a measure that currently does not exist.
“From a quality perspective, we were quite shocked to learn that India currently does not require either bioequivalence studies or stability testing for most, not all, generics being sold in the Indian market,” Thakur and Reddy stated in their report, adding that the DCC only recommended such tests for exports to other countries to preempt any concerns regarding quality.
Besides the new structure of regulatory enforcement, Thakur has advised that the government needed to enact a public procurement law to govern the procurement of drugs by public funded organisations. This would foster more uniform blacklisting norms and transparency between public procuring agencies, the report proposed.
