Government plans mandatory registration for pharma packaging suppliers

India's USD 30.5-billion pharmaceutical export industry, which supplies medicines to more than 200 countries, could soon see tighter oversight of one of its least regulated links, the printing and packaging supply chain.

In a news published today, it is reported that Central Drugs Standard Control Organisation (CDSCO) has proposed mandatory registration for manufacturers and suppliers of pharmaceutical packaging materials following investigations into counterfeit batches of semaglutide and anti-rabies vaccines that exposed vulnerabilities in packaging traceability. The proposal, if implemented, would bring printers and packaging converters supplying the pharmaceutical sector under a formal government registration framework for the first time.

Under the proposed system, packaging manufacturers would be required to obtain a registration certificate and a unique registration number through a government portal. That identification number would be printed on pharmaceutical packaging, enabling regulators to trace cartons, labels and other packaging components back to the company that produced them. The proposal also calls for registered companies to maintain records relating to artworks, printing plates, cylinders and other production assets used to manufacture pharmaceutical packaging.

The move comes amid growing global concern over falsified medicines. According to the World Health Organisation, one in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, posing a significant challenge to public health. Counterfeit medicines often rely on packaging that closely resembles genuine products, making printed cartons, labels, blister packs and package inserts a critical line of defence in protecting the integrity of the pharmaceutical supply chain.

While counterfeit medicines attract considerable public attention, official surveillance suggests India's regulated pharmaceutical supply chain remains largely compliant. According to data released by the Ministry of Health, spurious medicines accounted for around 0.2% of more than 1,16,000 drug samples tested during 2024-25. However, regulators believe recent investigations demonstrate how genuine packaging materials can be diverted and misused, highlighting the need for greater traceability throughout the packaging supply chain.

The proposal represents a significant shift in regulatory thinking. Until now, pharmaceutical packaging suppliers have largely remained outside direct government oversight, with supplier qualification managed by individual pharmaceutical companies under the quality requirements of Schedule M of the Drugs Rules. The proposed framework would create an official register of packaging suppliers, recognising converters not merely as vendors but as an integral part of the pharmaceutical quality and traceability ecosystem.

For the printing and packaging industry, the proposal is less about the printed carton itself and more about recognising packaging as part of the product's security architecture. By bringing converters into the regulatory net, CDSCO is signalling that packaging is no longer viewed simply as a branding or compliance tool, but as an important safeguard against the diversion and misuse of medicines.

The industry has broadly welcomed the intent behind the proposal, while cautioning that implementation will determine its effectiveness.

Faheem Agboatwala, managing director of Hi-Tech Printing Services, said the proposal addresses a longstanding regulatory gap in the pharmaceutical packaging supply chain. "Today, there is no formal process. It is largely based on trust. If someone says they are supplying pharmaceutical packaging, that is often accepted. Only the larger pharmaceutical companies insist on certifications such as GMP or ISO standards and conduct detailed vendor audits," Agboatwala told What Packaging.

According to Agboatwala, the proposed registration is unlikely to substantially change the procurement practices of India's leading pharmaceutical companies, many of which already maintain supplier qualification systems that are more stringent than regulatory requirements.

"The bigger pharmaceutical companies are already protected because they conduct comprehensive audits before approving packaging suppliers," he said. "Where this proposal could make the biggest difference is among smaller pharmaceutical companies and ayurvedic manufacturers, where vendor qualification processes are often less rigorous. A formal registration framework would help establish a more consistent baseline."

Another converter, who does not currently supply pharmaceutical packaging, welcomed the proposal, saying greater traceability could reduce the risk of counterfeit medicines entering the supply chain by improving accountability among packaging manufacturers.

Not everyone, however, is convinced that registration alone will deter counterfeiters. Another converter questioned whether additional documentation requirements for legitimate packaging manufacturers would significantly disrupt the operations of criminal networks producing fake medicines, suggesting that the effectiveness of the proposal would ultimately depend on enforcement.

Those contrasting opinions reflect the challenge facing regulators. Registration can improve traceability and establish a clear audit trail when counterfeit packaging is discovered, but industry observers note that the framework will need to be supported by robust enforcement, regular inspections and effective monitoring if it is to achieve its intended objective.

Several operational questions also remain unanswered. It is yet to be clarified whether the registration requirement will extend to all suppliers of printed pharmaceutical components, including labels, package inserts, blister foils and flexible packaging, or how the proposed system will integrate with existing supplier qualification programmes already operated by pharmaceutical manufacturers.

The proposal is expected to be examined by the Drugs Consultative Committee before any implementation roadmap is finalised.

For India's printing and packaging industry, the proposal marks an important shift in the role of packaging within the pharmaceutical supply chain. If adopted, it would bring converters under direct regulatory oversight for the first time, recognising that the security of a medicine depends not only on what is inside the pack, but also on the integrity and traceability of the pack itself.