The government has proposed to bring manufacturers and suppliers of printed pharmaceutical packaging materials under a formal registration framework, as it seeks to tighten the traceability mechanism for medicines following the seizure of counterfeit batches of weight-loss drug Semaglutide and rabies vaccines.
The registration number would be printed on all pharmaceutical packaging, making it possible to trace every box, strip or label back to the entity that produced or printed it.
The move initiated by the Central Drugs Standard Control Organisation (CDSCO) gains significance as other than the Semaglutide incident, a complaint was earlier received from international authorities regarding counterfeit products falsely represented as medicines of Indian origin, the people told ET.
It has been found that in some cases, only the printed packaging materials of pharmaceutical products were exported from India, the people said. Those materials were subsequently misused by foreign entities for repackaging counterfeit drugs abroad, they said.
“During investigations relating to products including Semaglutide and anti-rabies vaccine, too, it was observed that genuine printed packaging materials were allegedly diverted and misused for the manufacture, repackaging and distribution of spurious and counterfeit drugs,” said one of the people.
At present manufacturers and suppliers of printed pharmaceutical packaging materials are not subject to any specific registration or licensing mechanism under the Drugs and Cosmetics Act, 1940 and Rules.
Their control is primarily dependent upon vendor qualification and supplier management systems maintained by licensed drug manufacturers under the provisions of Schedule M of the Drugs Rules, 1945.
There is a regulatory gap in the manufacture and supply of printed pharmaceutical packaging materials, which is concerning, the person said. The drugs Consultative committee under the CDSCO will soon take up the matter for deliberation, the people said.
Investigations have found involvement of certain printing entities engaged by licensed drug manufacturers in the diversion and supply of original packaging materials to unauthorised people and traders, according to the people ET spoke with. Since such packaging materials are identical to those used for genuine products, their misuse significantly hampers the ability of regulatory authorities and legitimate manufacturers to distinguish genuine products from counterfeit or spurious drugs.
