India’s new pharma packaging registration rules target counterfeit drug supply chain

INDIA – The Central Drugs Standard Control Organisation has proposed mandatory registration for printed pharmaceutical packaging manufacturers and suppliers, requiring a Packaging Registration Certificate and unique identification number to trace every package back to its producer.

The new rules follow investigations that exposed the diversion and misuse of authentic packaging materials for counterfeit weight-loss drugs and vaccines.

The move addresses a significant regulatory gap, as manufacturers of printed pharmaceutical packaging are currently not required to obtain specific registration under the Drugs and Cosmetics Act, 1940, with oversight largely dependent on vendor qualification systems maintained by licensed drug manufacturers. 

Investigations into counterfeit batches of Semaglutide and anti-rabies vaccines revealed that genuine printed packaging materials were exported from India and subsequently misused by foreign entities for repackaging counterfeit drugs abroad. 

The Drugs Consultative Committee under CDSCO will soon take up the matter for deliberation, with the proposal representing a significant shift in regulatory thinking that would bring converters into the regulatory net for the first time.

How Registration Numbers and Government Portal Enable End-to-End Packaging Traceability

Under the proposed framework, each manufacturer of printed pharmaceutical packaging will be required to obtain a registration certificate and a unique registration number through a government portal, which will be printed on every pharmaceutical package. 

This identification number will enable authorities to trace each box, strip, or label back to the manufacturer or printer responsible for its production. 

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. 

Investigations have uncovered the involvement of printing firms contracted by licensed drug manufacturers in diverting and supplying genuine packaging materials to unauthorised individuals and traders. 

Since these materials are identical to those used for legitimate medicines, their misuse makes it significantly more difficult for regulators to distinguish authentic products from counterfeit or spurious drugs.

What the Regulatory Shift Means for India’s US$30.5 Billion Pharmaceutical Export Industry

India’s US$30.5 billion pharmaceutical export industry, which supplies medicines to more than 200 countries, could see the printing and packaging supply chain brought under formal regulatory oversight for the first time. 

According to the World Health Organization, one in 10 medical products circulating in low- and middle-income countries is either substandard or falsified, posing a significant public health challenge. 

Industry experts note that while larger pharmaceutical companies already maintain rigorous supplier qualification systems, the proposed registration could establish a consistent baseline among smaller pharmaceutical manufacturers and ayurvedic producers where vendor qualification processes are often less rigorous.

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