Drug firms to now face bans for fake claims, as govt to tweak rules

The changes, based on recommendations of the Drugs Technical Advisory Board (DTAB), will give the Central Drugs Standard Control Organization (CDSCO) and state regulators explicit powers to debar offenders—a gap that until now was handled only through administrative action.

The plan is now in the draft stage, and is likely to be enforced shortly following consultation with the industry stakeholders.

“The main reason for these changes is to deter and punish any individual or company that attempts to gain a drug licence by presenting misleading, fake, or fabricated documents or information,” a senior official told Mint, requesting anonymity. “The new debarment power is to protect the public from low-quality, potentially harmful medicines entering the market.”

The tightening of the rules assumes significance for India, the world’s largest supplier of generic medicines, exporting over 20% of global volumes to more than 200 countries, including the US and EU. Officials said the reform reflects a zero-tolerance policy against dishonesty in licensing, aimed at safeguarding both public health and India’s reputation for manufacturing quality-assured, affordable drugs.

Before any such ban order by the CDSCO, India’s apex drug regulator, the manufacturers will be given an opportunity to show cause in writing. Those banned can also appeal against the order within 30 days.

The official cited above said this action is being formalized because “when the CDSCO or the state drug regulator now receives such fake or wrong documents , we take administrative action, but the specific penalties are not explicitly detailed in the drug rules. The government is now addressing this by introducing a legal provision into the Drugs Rules, 1945.”

The documents show that the provision explicitly states the grounds for action: “Whoever himself or, any other person on his behalf, or applicant is found to be guilty of submitting misleading, or fake, or fabricated documents/ information, may, after giving him an opportunity to show cause as to why such an order should not be made, in writing, stating the reasons thereof, be debarred by the Licensing Authority for such period as deemed fit”.

“This move shows a zero-tolerance policy against dishonesty in the licensing process, which is crucial for maintaining the integrity of the entire pharmaceutical supply chain. By weeding out dishonest players, the new rules will ensure that only compliant and quality-focused firms remain, which is vital for securing international tenders and export markets,” the official said.

Queries sent to the health ministry spokesperson remained unanswered.

Are the actions enough?

Giving fake details to get manufacturing permits for drugs could warrant an even stiffer penalty, some experts said. Dr K. Srinath Reddy, former president of the Public Health Foundation of India, emphasized that public safety as well as India’s reputation for manufacture of quality assured drugs for the global market should not be compromised by these spurious drugs.

“Obtaining licences for drug manufacture on the basis of spurious documents is a serious crime that merits severe penalties even beyond banning of manufacture by an offending firm,” Reddy said. “Testing the quality and safety of drugs already in the market is an important function of drug regulation, where the weaknesses of several state regulatory authorities are showing up as distressing media reports when cough syrups or eye drops cause serious adverse events that can even be fatal.”

“If state regulators do not have adequate testing capabilities, that must be addressed forthwith. Drug testing capacity that is potentially available in schools of pharmacy and university departments of chemistry should be utilized to expand the capacity in states. A poorly manufactured or unsafe drug, if licensed in one state, can be distributed nationwide. So, every state must have competent and incorruptible state regulatory agencies,” Dr Reddy said.

He added that the proposed action against these malpractices is a welcome measure but its effect will be post-facto. “We must take measures both to prevent the manufacture of spurious or low quality drugs and to plug regulatory loopholes which permit their entry into the market.”