The Indian government is considering tighter regulations for manufacturers and suppliers of printed pharmaceutical packaging materials as part of a broader effort to combat the growing circulation of counterfeit medicines.
According to the minutes of the 69th Drugs Consultative Committee (DCC) meeting, authorities are exploring the introduction of a mandatory online registration system for companies producing pharmaceutical packaging such as cartons, labels, blister foils, strips, and package inserts. A DCC subcommittee has been formed to assess the proposal’s feasibility and recommend an appropriate regulatory framework.
Why The Move Matters
Printed pharmaceutical packaging plays a crucial role in helping consumers and healthcare professionals distinguish genuine medicines from counterfeit products. However, regulators have raised concerns over the increasing number of fake drugs that closely resemble original brands, posing serious risks to public health.
Recent enforcement actions include the seizure of counterfeit Chymoral Forte and Gudcef Plus in Uttar Pradesh, as well as the busting of a fake Mounjaro injection racket involving counterfeit packaging materials.
Proposed Registration Framework
Under the proposal, manufacturers and suppliers of printed pharmaceutical packaging could be required to register through an online system. The subcommittee will examine whether such regulation is legally feasible under the Drugs and Cosmetics Act, 1940, and recommend amendments to the Drugs Rules, 1945, if necessary.
The panel has also been asked to consult experts from the pharmaceutical, packaging, and legal sectors before submitting its recommendations.
Industry Raises Practical Concerns
While the pharmaceutical industry supports stronger measures against counterfeit medicines, experts have questioned how the government would regulate the vast printing industry, which also serves sectors such as FMCG and consumer goods.
Industry representatives argue that bringing all printing companies under drug regulations could be challenging due to the size and diversity of the market. However, many agree that stricter oversight is needed as counterfeit medicines increasingly damage the reputation of Indian pharmaceutical companies in both domestic and international markets.
Next Steps
The DCC subcommittee will submit its report outlining the necessity and practicality of the proposed registration system. If mandatory registration is found to be impractical, the panel will recommend alternative measures to prevent the misuse of pharmaceutical packaging materials in the production and distribution of counterfeit drugs.
The recommendations will then be reviewed by the Drugs Consultative Committee before any regulatory changes are introduced.