At present, there is no provision under Drugs Rules, 1945 to address issues of wrong information to obtain regulatory approvals.
The Centre has come out with draft rules which seek to amend the Drugs Rules, 1945 to debar drugmakers who give misleading or fake information to the licensing authorities.
It has invited suggestions and objections from stakeholders within 30 days.
At present, there is no provision to address such false submissions by drug-makers to get regulatory nod.
According to the present rules, suspension and cancellation of registration certificate or licence takes place if the manufacturer fails to comply with any of the conditions of the registration certificate/license.
However, with this proposed amendment, the licensing authority will now be able to debar applicants, alongside suspension or cancellation of registration certificates and licences.
In a gazette notification released on October 28, the Union health ministry said that whoever is found guilty of submitting misleading, fake or fabricated documents and information, may be debarred by the licensing authority.
As part of the debarment process, the licensing authority will also give aggrieved parties an opportunity to appeal and respond to show cause notice within 30 days of its receipt, except for import or manufacture of new drug for clinical trials or marketing, where 60 days are given for appeal.
Rishi Agrawal, chief executive officer (CEO) and co-founder of Teamlease Regtech said that while such cases happen in both state and central jurisdiction levels, no validated national percentage exists for the frequency of companies submitting false documents to licensing authorities.
"High profile cases show that this can be systemic at a manufacturer and supply chain level, but they are not a statistical sample of the whole industry," he added.
For example, the US food and drug administration (USFDA) in 2012 had alleged that Ranbaxy was submitting falsified data and test reports for one of its plants in several approved and pending drug applications across the world.
Experts indicate that falsification at the state level may include forged factory test reports, fake analyst signatures and site documents presented during license applications, whereas deliberate data fabrication or manipulation is seen at the Central level.
Another industry executive said that earlier the regulator used to take action against fake information according to provisions mentioned in the Indian Penal Code (IPC) and filing a first information report (FIR), if needed.
"But the inclusion of such provisions in the rules will make the drug regulator's work easier and faster," he added.
The move also comes after the issue was discussed in the 91st meeting of the Drug Technical Advisory Board (DTAB) in August last year.
The DTAB serves as the highest statutory body on technical matters related to drugs, cosmetics and medical devices in India.
"The DTAB deliberated the matter and recommended that in such cases, the applicant may be debarred for submitting forged or fabricated, misleading data or documents to licensing authority in addition to suspension/cancellation of the product as applicable," stated the minutes of the meeting reviewed by Business Standard.
Feature Presentation: Aslam Hunani/Rediff
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