India Pharma Outlook Team | Friday, 26 June 2026
A packaging loophole allegedly helped counterfeit medicines enter global markets using genuine-looking pharmaceutical packaging.
The Centre is now preparing stricter rules to improve traceability and hold packaging manufacturers accountable.
The proposed move comes after authorities found that genuine printed packaging made in India was allegedly diverted and used to pack counterfeit drugs, making them look authentic.
The packaging loophole has raised concerns about gaps in the pharmaceutical supply chain and prompted the government to introduce a new registration system for packaging suppliers.
The proposal aims to make every manufacturer of printed pharmaceutical packaging directly accountable by requiring them to obtain a Packaging Registration Certificate and a unique registration number. This number will be printed on packaging materials, allowing regulators to trace them back to the original manufacturer if any misuse is detected.
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At present, manufacturers of printed pharmaceutical packaging are not directly regulated under the Drugs and Cosmetics Act. Instead, pharmaceutical companies approve and monitor these vendors through their own quality systems under Schedule M. Officials believe this creates a gap that can be exploited if packaging materials are diverted outside the authorized supply chain.
To address this, the government is working on a system where every packaging manufacturer must register through a dedicated online portal before supplying printed materials to pharmaceutical companies.
The proposed framework includes:
The proposal is expected to be discussed by the Central Drugs Standard Control Organisation (CDSCO)'s Drugs Consultative Committee before being implemented.
The move follows investigations into counterfeit Semaglutide and anti-rabies vaccines that surfaced in international markets. Authorities found that genuine printed packaging manufactured in India had allegedly been diverted and later used to package fake medicines.
Because the packaging itself was authentic, counterfeit products closely resembled genuine medicines, making them difficult for regulators, healthcare professionals, and consumers to identify.
Investigators also found that some printing companies supplying legitimate pharmaceutical manufacturers allegedly diverted excess or unused printed packaging to unauthorized traders. These materials later entered illegal supply chains, allowing counterfeit medicines to be sold in packaging that appeared genuine.
The findings highlighted that while drug manufacturers follow strict quality standards, similar oversight does not exist for companies producing printed packaging materials.
The proposed registration system is expected to strengthen India's pharmaceutical supply chain and reduce the risk of counterfeit medicines reaching patients.
If implemented, the new rules could:
India is one of the world's largest suppliers of generic medicines, making packaging security an important part of maintaining product quality and protecting patient safety. With counterfeit medicines posing a growing global challenge, the government is looking to ensure that packaging materials receive the same level of oversight as pharmaceutical products themselves.
If approved, the proposed registration framework would mark a major shift in the regulation of pharmaceutical packaging and close a long-standing gap that investigators believe has allowed counterfeit medicines to move through the supply chain undetected.
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