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, exposing a regulatory gap that authorities say threatens public health and the reputation of India's pharmaceutical industry.
The drug regulator has begun internal discussions on a mandatory online registration framework for these entities through amendments to the Drugs Rules, 1945, according to two officials and government documents reviewed by Mint.
The move affects India's $50 billion pharmaceutical industry, which supplies 20% of global generic medicines and 60% of vaccines to more than 200 countries.
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 officials said.
“A sub-committee is being formed to brief the main panel on how this can be executed because the proposal requires further deliberation. The planned sub-committee will examine the necessity and feasibility of the registry, outline baseline eligibility conditions, evaluate documentation requirements, and finalize verification obligations for registered printing entities,” one of the officials cited above said.
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 that framework is insufficient to prevent the diversion, unauthorized supply and misuse of genuine packaging materials.
Queries sent to the health ministry and the drug controller's office remained unanswered.
Exposing the gap
The proposal follows investigations that found genuine pharmaceutical packaging materials being diverted for counterfeit medicines.
According to a government document, 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.
The document said such incidents threaten public health and undermine the credibility of India's pharmaceutical industry in global markets. “Investigations have also disclosed the involvement of certain printing entities engaged by licensed drug manufacturers in the unauthorized diversion and supply of original packaging materials to unauthorized persons and traders.”
“Since such packaging materials are identical to those used for genuine products, their misuse hampers the ability of regulatory authorities and manufacturers to distinguish genuine products from counterfeit drugs,” the document said.
Although printing and labelling are treated as part of drug manufacturing under the Drugs and Cosmetics Act, manufacturers of printed pharmaceutical packaging materials are not currently required to obtain licences.
Registry, traceability and inspections
To close that gap, the government proposes an online registration framework for manufacturers and suppliers of printed pharmaceutical packaging materials.
"In order to ensure accountability, traceability, and regulatory responsibility, the government proposes to introduce an online registration framework for manufacturers and suppliers of printed pharmaceutical packaging materials used for drugs," the document said.
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. Packaging materials could be supplied only to licensed drug manufacturers after verification, while registered premises would be open to inspection by regulators.
"The proposed registration mechanism is intended to provide regulatory oversight without imposing financial or infrastructure burdens on the manufacturers of printed packaging materials," the document said.
Industry executives offered mixed views on the proposal.
"The plan is good in intent but difficult in practicality because the packaging industry does not naturally fall under the Act, making regulation complex. Furthermore, illegal operations bypass licensing entirely, so adding compliance layers for legitimate printers will not deter bad actors operating outside the framework," said an industry source, requesting anonymity.
Mankind Pharma's Soumyanath Mishra, head and AVP, packaging research and development, said, “The proposed mandatory registration of pharmaceutical packaging printers is a significant step toward strengthening the integrity of the pharmaceutical supply chain. The initiative provides companies with greater assurance that suppliers comply with quality and regulatory standards. Ultimately, this oversight enhances patient safety, protects brand reputation, and boosts the global credibility of Indian pharmaceutical products.”
Officials are considering a registration architecture similar to the online system used for medical devices.