Published Sep 16, 2026 | 7:00 AM ⚊ Updated Sep 16, 2026 | 7:00 AM
Synopsis: Nearly two months before Karnataka uncovered an alleged counterfeit drug supply network involving forged Pfizer labels, the DCC had flagged pharmaceutical packaging as a potential vulnerability. Its June 24 minutes proposed examining the registration of packaging manufacturers and suppliers. The August Bidadi raid exposed forged labels, packaging material and filling equipment, highlighting the unresolved regulatory gap.
Nearly two months before the Karnataka authorities raided an alleged counterfeit medicine racket and seized forged pharmaceutical labels, India’s top drug regulatory advisory body had already flagged the potential diversion and misuse of printed pharmaceutical packaging material and was examining whether the manufacturers and suppliers of such material should be brought under a registration framework.
The issue was taken up by the Drugs Consultative Committee (DCC) at its 69th meeting on 24 June 2026, at the Central Drugs Standard Control Organisation (CDSCO) headquarters in New Delhi. The meeting was chaired by Dr Rajeev Singh Raghuvanshi, Drugs Controller General of India.
The committee raised the issue in a proposal titled: “Proposal for Regulation of Manufacturers and Suppliers of Printed Pharmaceutical Packaging Materials to Prevent Illicit Diversion and Misuse in Spurious and Counterfeit Drug Circulation, and to Safeguard Public Health and Supply Chain Integrity.”
The proposal sought to introduce an online registration framework for manufacturers and suppliers of printed pharmaceutical packaging materials used for drugs.
The committee did not approve the proposed registration system. Instead, it recommended constituting a sub-committee to examine whether such a system could be introduced.
The minutes state that the sub-committee must “evaluate the feasibility of the proposal for introducing an online registration framework for manufacturers/suppliers of printed pharmaceutical packaging materials used for drugs in light of the definition of ‘drug’ and ‘manufacture’ under the Drugs and Cosmetics Act, 1940.”
The sub-committee was assigned three specific tasks: examine the necessity and feasibility of an online registration framework, suggest an appropriate regulatory framework for insertion under the Drugs Rules, 1945, by way of amendment, and recommend “any other measures considered necessary to prevent diversion and misuse of pharmaceutical packaging materials in the manufacture and circulation of spurious and counterfeit drugs.”
The DCC recommended that the sub-committee can take opinions from experts in the packaging industry, and if required, a legal expert.
The report of the sub-committee is to be placed before the DCC for further deliberation.
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On 18 August, Karnataka’s Food Safety and Drugs Administration raided a farmhouse at Kurubarekaranahalli near the Bidadi toll gate and uncovered what it described as an “unlicensed pharmaceutical repacking and relabelling” unit.
According to the department’s press note, the premises “was being used to procure lower-cost medications from other states, which were then allegedly filled into new vials and relabelled to mimic expensive multinational corporation (MNC) brands and imported drugs by name Pfizer.”
The note also states that “the scanning codes were non functional in the label used for this purpose.”
Officials estimated the total seizure at ₹4,91,49,575. The inventory included suspected medicines, expired drugs, packaging components, an injection-filling machine and “forged labels and stamps.” The forged labels and stamps were valued at ₹2 lakh, while the injection-filling machinery was valued at ₹5 lakh.
The Karnataka Food Safety and Drug Administration (FDA) said the operation involved an alleged unlicensed manufacture, storage and distribution network. It cited Section 17B of the Drugs and Cosmetics Act, 1940, in relation to spurious drugs and said punishment under Section 27 could range from a minimum of 10 years to life imprisonment.
The seized material included 5,640 vials of CEFIAVIGENT 2.5 Injection, 1,531 vials of HIZLAM Injectables, 470 vials of Xavitaz Injection, 264 vials of EMBLAVEO, 165 vials of Zavicefta Injection, 44 TIGYNT IV vials, 44 Tigvnet injections, 190 Aztreo injections and 50 Trezam injections, besides 30 boxes of expired drugs.
The FDA has sent samples of the seized products for laboratory testing to establish their chemical composition, sterility and potency.
The Karnataka government subsequently escalated the investigation by constituting a six-member Special Investigation Team (SIT).
Karnataka Health Minister UT Khader said the state acted quickly after the raid:
“We did not wait a single day. On August 19, after discussion with CM DK Shivakumar and Home minister Priyank Kharge constituted a six-member SIT headed by a senior IPS officer to lead a major inter-state investigation.”
Khader described the suspected supply chain as extending beyond Karnataka: “This network was procuring cheap bulk drugs from manufacturing hubs in Telangana and Himachal Pradesh, refilling them into new vials at the Bidadi facility, and relabelling them as premium imported brands of multinational companies, including Pfizer counterfeit drugs meant for patients and ICU wards.”
He said the state had sought assistance from the Centre to trace the wider network. “On 19th August, I have written in detail to Union Health Minister JP Nadda seeking the support of CDSCO and central regulatory agencies to map this network’s supply chain and stop nationwide distribution.”
He also said the investigation would pursue everyone involved: “We will track down every link in their network, dismantle it brick by brick and ensure every person responsible faces the harshest punishment under law.”
The Karnataka government said the list of suspected spurious and counterfeit drugs had been communicated to the Union government and all state governments, while hospitals and nursing homes in Karnataka had been directed not to use the seized medicines.
As part of the investigation, the SIT and the Drugs Control Department raided Krupa Healthcare near Minerva Circle in Bengaluru, where stacks of suspected counterfeit medicines were seized, following which its owner was arrested. Police suspect that the alleged counterfeit medicine racket supplied fake medicines, including fake cancer drugs, to as many as 90 hospitals and clinics in and outside Bengaluru.
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The DCC proposal highlight a basic regulatory question: can manufacturers and suppliers of printed pharmaceutical packaging material be brought within the existing drug regulatory framework, or is a separate amendment to the Drugs Rules required?
The sub-committee was directed to examine the issue in the context of the definitions of “drug” and “manufacture” under the Drugs and Cosmetics Act, 1940. It also asked the panel to consider alternative safeguards if a registration system proved unfeasible.
The discoveries made by the Karnataka police provide a real-world example of the vulnerability the committee was examining. Investigators found forged pharmaceutical labels and stamps, packaging components and equipment for filling injections at the alleged repacking facility.
The Karnataka FDA’s press note identifies labels bearing the names of pharmaceutical companies, including Pfizer, but does not identify who printed or supplied the forged labels.
Meanwhile, the DCC has neither set a deadline for the sub-committee’s report nor identified its members.
That leaves an important regulatory question unresolved: who is responsible for tracking the supply of pharmaceutical packaging material that can be diverted and used to make a counterfeit medicine appear genuine?
The answer could determine whether regulators can follow another critical link in the counterfeit-drug supply chain, from the medicine itself to the packaging that gives it the appearance of legitimacy.
(Edited by Fayisa CA)
