Last Updated on January 13, 2026 by The Health Master
Fake Documents
The Union Ministry of Health and Family Welfare has taken a very determined approach to overhauling the regulatory approvals aspect of the critical pharmaceutical sector with respect to fake documents.
A draft of the Drugs and Cosmetics Rules, 1945 has been floated that proposes debarment of individuals and entities that submit misleading, forged or fake documents to the licensing authority.
Substance of the Draft Amendment of Debarment
Essentially, the draft aims to introduce legal consequences to ensure honesty by presenting debarment as a newfound consequence with substantive implications for applicants in relation to:
- Manufacture
- Sale and Supply
- Trial and Research
- Testing and Evaluation
The publication of this document was made official in the Official Gazette on October 28 (published on October 16).
As it has been set out for public consideration, this is an interim measure, meaning formal consideration will occur after a period of 30 days from the date the Gazette copy is made publicly available.
This time serves to invite objections and suggestions from the public, which the Central Government intends to consider.
Legal Components
Furthermore, several new rules will be introduced as part of this measure, including Rules 29B, 66B, 84F, 93A, 122DBA, 122Q, and 150L.
The heart of the newfound power is found in Sub-rule (1):
“Whoever himself, or any other person on his behalf, or applicant is found to be guilty of submitting misleading or fabricated or fake documents / information, may… be debarred by the Central Licensing Approving Authority or Licencing Authority for such period as deemed fit”.
This gives the licensing authority the ability to formally sanction an applicant nbut only after giving that applicant a “show cause” opportunity (an explanation as to why it should not receive such a sanction).
The Safety Valve: A Right to Appeal
Sub-rule (2) also outlines an important element of an appeal provision should an order of debarring be issued.
If an applicant is “aggrieved” upon receiving an order of debarment, they have thirty days to make an appeal with the government.
This is essential for fairness and due process in ensuring that a secondary entity can review such an extensive ban and at least give credence to the debarred applicant’s right to be heard.
Identified Need by DTAB
This did not happen spontaneously. The Drugs Technical Advisory Board (DTAB), an advisory committee for technical matters, noted a need during a prior meeting where it reviewed the existing Drugs Rules, 1945, and found no clear provision to officially direct any applicant to be debarred when approvals were sought with forged data.
At the August 14, 2024 meeting, it noted that merely suspending/canceling approval at a product level was insufficient; the data submitted was endorsed by an applicant who needed separate sanctions.
This would punish the deceptive activity that undermines public safety rather than merely undermining a specific product that existed under these fake pretenses.
The new debarment rules will be tagged onto existing rules governing different facets of the industry:
| Existing Rule | Primary Area of Regulation |
| Rule 29 | Import License Suspension and Cancellation |
| Rule 66 | Suspension/Cancellation of Sales License |
| Rule 84/93 | Manufacturing License for Domestic/Export Sale |
| Rule 122DB | Permission for New Drug Clinical Trials/Marketing |
| Rule 122Q | Blood Centres Licensing and Related Activities |
| Rule 150L | Institutions Testing Drugs and Raw Materials |
Q: What does ‘debarment’ mean in Drugs Rule?
According to this proposed re-amendment to existing rules, debarment means that an applicant will be officially prohibited from engaging in activities like applying for new licensures, manufacturing products, or conducting clinical trials/development efforts for a designated period of time determined by the licensing authority upon finding a regulatory violation (like submitting fake documents).
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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