New Delhi: India plans to crack down on applicants who submit false or misleading documents to obtain drug licenses – a move that could reshape compliance standards in the country’s $50 billion pharmaceutical industry. According to a senior official and draft rules reviewed by Mint, the health ministry proposed changes to the 1945 drug rules to empower licensing authorities to ban any entity found guilty of producing forged or fabricated documents “for such period as it may think fit”.
The changes, recommended by the Drugs Technical Advisory Board (DTAB), will give the Central Drugs Standards Control Organization (CDSCO) and state regulatory bodies express powers to report offenders – a loophole that has so far only been addressed through administrative measures.
The plan is now at the draft stage and is likely to be implemented soon after consultation with industry stakeholders.
“The main reason behind these changes is to deter and penalize any individual or company who tries to obtain a drug license by submitting misleading, false or fabricated documents or information,” a senior official told Mint, requesting anonymity. “The new debarment force is to protect the public from substandard, potentially harmful drugs entering the market.”
The tightening of rules is significant for India, the world’s largest supplier of generic drugs, exporting more than 20% of global volume to more than 200 countries, including the US and the EU. Officials said the reform reflected a zero-tolerance policy against dishonesty in licensing aimed at protecting public health and India’s reputation for manufacturing affordable, quality-assured drugs.
Manufacturers will be given an opportunity to show cause in writing before any such ban by CDSCO, India’s apex drug regulator. Banned persons can also appeal the order within 30 days.
The above official said the measure is being formalized because “when CDSCO or the state drug regulator now receives such fake or incorrect documents, we take administrative action, but the specific penalties are not specifically mentioned in the drug rules. The government is now addressing this by introducing a legal provision in the drug rules, 1945.”
The documents show that the provision expressly states the reasons for the action: “Whoever himself or any other person acting on his behalf or the applicant is found guilty of furnishing misleading, false or fabricated documents/information may, after being given an opportunity to show cause why such order should not be made, in writing stating the reasons, be banished by the Licensing Authority for such period as it thinks fit”.
“This move demonstrates a zero-tolerance policy against dishonesty in the licensing process, which is critical to maintaining the integrity of the entire pharmaceutical supply chain. By weeding out rogue players, the new rules will ensure that only compliant and quality-oriented firms remain, which is critical to securing international tenders and export markets,” the official said.
Inquiries sent to a spokesperson for the Ministry of Health went unanswered.
Are the actions sufficient?
Some experts said that providing false details to obtain a license to manufacture drugs could warrant an even harsher sentence. Dr. K. Srinath Reddy, former president of the Public Health Foundation of India, emphasized that public safety, as well as India’s reputation for producing quality-assured drugs for the global market, should not be compromised by these fake drugs.
“Obtaining licenses to manufacture drugs on the basis of false documents is a serious crime that deserves severe punishment beyond the banning of production by the offending firm,” Reddy said. “Testing the quality and safety of drugs already on the market is an important function of drug regulation, where the weaknesses of several state regulators have been highlighted by disturbing media reports of cough syrups or eye drops causing serious side effects that can be fatal.”
“If state regulators do not have sufficient testing capabilities, this needs to be addressed immediately. The drug testing capacity potentially available in pharmacy schools and university chemistry departments should be used to expand 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 regulators,” said Dr Reddy.
He added that the proposed measure against these malpractices is a welcome measure but its effect will be post-facto. “We need to take action to prevent counterfeit or substandard medicines from being produced and to close the regulatory loopholes that allow them to enter the market.”
