BENGALURU: What began with a tipoff about an unlicensed pharmaceutical operation at a Bidadi farmhouse has widened into a probe into the alleged manufacture, relabelling and distribution of spurious medicines.
With laboratory reports awaited and the supply chain still under investigation, the case has now raised questions that go beyond the seizure at Bidadi, including how suspected spurious medicines entered the distribution network, how they reached healthcare facilities, whether procurement safeguards were followed and whether existing regulatory checks were effective.
While the investigation by a Special Investigation Team (SIT) set up by the state government is in full swing, tracing the end-customers who received these spurious drugs seems to be a challenge. Amid the ongoing probe, no attention is being given to check how these drugs could have impacted the health of hapless patients.
The lone incident has cast a shadow on the entire medical supplies chain, leading experts to call for a probe to examine not just those directly involved but also the regulatory and procurement systems that may have allowed the alleged racket to operate.
Dr Gopal Dabade, president, Drug Action Forum-Karnataka, said the first priority should be to identify those behind the racket and ensure that the investigation is transparent and leads to stringent action against those responsible. He questioned how suspected spurious medicines could enter the market and reach hospitals despite existing provisions under the Drugs and Cosmetics Act, and regulatory mechanisms in place.
Dabade said drug inspectors are expected to inspect manufacturing and distribution establishments and verify records, including the source of raw materials and chemicals, procurement documents and other records maintained by companies. He also raised concerns over the shortage of drug inspectors and questioned whether existing inspection mechanisms were being implemented effectively.
He also pointed to the difficulty of enforcing drug regulations across state borders. If a drug inspector identifies a substandard or spurious medicine manufactured in another state, action may require coordination with the regulator in that state, though medicines can be distributed across state boundaries.
Dabade said the investigation should identify all those involved, rather than stopping with the person or premises where the suspected medicines were found. He said the probe should find out how the medicines reached hospitals and whether hospitals and distributors had adequate systems to verify the source and batch details of medicines they procured.
He called for greater scrutiny of the medicine supply chain, and said those found responsible should face stringent punishment. He also stressed that there should be no conflict of interest in the investigation and the inquiry should establish the complete chain behind the alleged racket.
Meanwhile, KM Gopakumar, co-convener, Working Group on Access to Medicines and Treatment, said the investigation should also examine the possible impact on patients. “If quality issues are confirmed, the patients to whom these medicines were prescribed should also be identified, and appropriate remedial measures taken,” he said.
He also called for the 90 hospitals reportedly linked to the investigation to be brought under its purview to determine how the medicines were procured and whether proper procurement procedures were followed. He said the objective should not merely be to punish those directly involved but also to identify the circumstances that allowed such a system to operate.
Gopakumar added that excessive profit margins in medicine sales could create incentives for low-cost procurement and subsequent sale at substantially higher prices. He called for measures to ensure that medicines remain affordable while curbing what he described as “exorbitant profit”. He said price and margin regulation could reduce the incentive for such practices, and that while price control would ideally require action by the Centre, the state government should also act concurrently rather than wait for central intervention.
He said essential medicines should first be made efficiently available through the public health system, followed by stronger regulation of the private market. On technology-based solutions, Gopakumar cautioned against relying solely on QR codes and barcodes to prevent counterfeit medicines. Such systems, he said, could potentially be duplicated, while expensive technological infrastructure could increase the cost of medicines.
THE CASE
On August 18, the Karnataka
Food Safety and Drug Administration’s
(FDA) Drug Enforcement Wing conducted a joint inspection at a farmhouse at Kurubarakeranahalli in Bidadi, following a tipoff. The department stated that medicines procured at lower costs from neighbouring states were being refilled into new vials and relabelled to resemble expensive multinational and imported medicines, including products carrying Pfizer labels.
The FDA said the seized materials, including suspected spurious drugs, expired medicines, machinery, packaging material and forged labels and stamps were estimated at Rs 5.05 crore. The department also found that QR/scanning codes on counterfeit labels were non-functional.
Among the seized medicines were 5,640 vials of Cefiavigent 2.5 injection, 1,531 vials of Hizlam injectables and 264 vials of Emblaveo carrying a Pfizer label, besides several other injectable medicines. Thirty boxes of expired drugs were also seized.
The department has blocked the relevant batch numbers and entries on the Karnataka FDA portal and sent samples to laboratories to examine their chemical composition, sterility and potency. A criminal case has also been registered under the Drugs and Cosmetics Act. The FDA cancelled the licences of 16 firms and suspended eight others. The licence of a Pfizer C&F depot at Kempalinganahalli in Nelamangala taluk was also suspended.
