India is moving to bring manufacturers and suppliers of printed pharmaceutical packaging materials under drug laws after investigations found genuine packaging being diverted for counterfeit medicines. According to reports from Mint, the drug regulator has begun internal discussions on a mandatory online registration framework for these entities through amendments to the Drugs Rules, 1945. As a first step, regulators are constituting a sub-committee to examine how the framework should operate before making recommendations to the main regulatory panel.
The proposed framework affects India's $50 billion pharmaceutical industry, which supplies 20% of global generic medicines and 60% of vaccines to more than 200 countries. As reported by Mint, currently, manufacturers and suppliers of printed pharmaceutical packaging materials are regulated only indirectly through vendor qualification and supplier management systems maintained by licensed drug manufacturers under Schedule M of the Drugs Rules, 1945. Regulators now believe this framework is insufficient to prevent the diversion, unauthorized supply and misuse of genuine packaging materials.
The proposal follows investigations that found genuine pharmaceutical packaging materials being diverted for counterfeit medicines. According to a government document reviewed by Mint, investigations involving products including Semaglutide and anti-rabies vaccines found authentic printed packaging materials had been diverted and misused in the manufacture, repackaging and distribution of counterfeit drugs. In another case, international authorities investigating counterfeit medicines falsely represented as Indian products found that only printed pharmaceutical packaging materials had been exported from India before being misused overseas to package fake drugs.
To close the regulatory gap, the government proposes an online registration framework for manufacturers and suppliers of printed pharmaceutical packaging materials. As reported by Mint, under the proposal, printing entities would obtain a Packaging Registration Certificate through a centralized online portal and receive a unique Packaging Registration Number, which must be printed on pharmaceutical packaging materials to enable traceability. Registered entities would also have to maintain records of artworks, customer orders, production, supplies, purchaser credentials, and the disposal or destruction of excess or obsolete packaging materials.
India's proposed packaging registration system comes amid a broader global push for pharmaceutical traceability and significant growth in the commercial printing market. According to latest market analysis, the global commercial printing market is valued at USD 622.52 billion in 2025 and is predicted to increase from USD 638.35 billion in 2026 to approximately USD 760.09 billion by 2033, growing at a CAGR of 2.77% from 2026 to 2033. The global commercial printing market is experiencing steady expansion driven by packaging demand, e-commerce growth, and technological advancement, with packaging applications accounting for approximately 32% of the total application segment in 2026.
