Karnataka’s Food Safety and Drugs Administration (FDA) has cancelled 16 drug licences and suspended eight others as part of an investigation into the alleged distribution and sale of spurious medicines.
The regulatory action follows an August 18 raid by the FDA’s Drug Enforcement Wing at an unlicensed facility in Kurubarakeranahalli near Bidadi. Officials seized suspected counterfeit medicines, packaging material, machinery and forged labels with a combined estimated value of around ₹5.05 crore.
Cheap Medicines Allegedly Repackaged as Expensive Drugs
- According to preliminary findings, investigators suspect that relatively inexpensive medicines sourced from other states were being transferred into new vials and relabelled as expensive medicines associated with multinational pharmaceutical companies.
- Some of the suspected counterfeit products reportedly carried forged Pfizer labels and other brand markings. Investigators also found QR and scanning codes on some labels that reportedly failed to function when checked.
- The seized stock included thousands of vials of injectable medicines, including products identified as CEFIAVIGENT, HIZLAM, EMBLAVEO, Zavicefta, TIGYNT and other injections. Officials said several of these medicines are used in the treatment of serious bacterial infections.
16 Licences Cancelled, Eight Suspended
- The FDA has cancelled 16 licences belonging to retailers and wholesalers linked to the investigation and suspended eight additional licences.
- Among the establishments facing cancellation are Avesco Healthcare, Bangalore Speciality Pharma, Bengaluru Speciality Pharma, Patel Medi Trade, Rajarajeshwari Pharma, N.S. Pharma, Surya Specialty Pharma, SWS Pharma, Krupa Healthcare and St. Philomena Hospital Drug Centre, among others.
- The eight suspended licences include those of several pharmaceutical establishments, with Pfizer Ltd’s wholesale licence in Bengaluru Rural district also reported among the suspended licences. The suspension is part of the ongoing regulatory investigation and does not by itself establish wrongdoing by every licence holder.
Investigation Expands to Supply Chain
- Officials are now investigating how the suspected medicines were procured, repackaged and distributed.
- A Special Investigation Team (SIT) is examining the wider supply chain and the possible involvement of suppliers, distributors, pharmacies and other intermediaries. Authorities are also checking purchase records, invoices and stock registers to determine where the suspected medicines were supplied.
- The seized material reportedly included an injection filling machine valued at around ₹7 lakh, along with packaging components, forged labels and stamps.
- Samples of the seized medicines have been sent for laboratory testing to determine their chemical composition, sterility and potency. Therefore, the exact contents and quality of individual seized products remain subject to laboratory confirmation.
Criminal Investigation Underway
- The FDA has registered a criminal case in connection with the suspected racket. Authorities said the suspected products fall under the legal definition of spurious drugs under the Drugs and Cosmetics Act.
- The investigation is continuing, and further action against individuals, pharmacies, distributors or other entities could follow if violations are established.
- The case has also attracted wider attention because investigators are examining possible interstate links. The Karnataka government has been considering whether the investigation should be transferred to the CBI, amid reports that the alleged network extends beyond the state.
Public Advisory
- The FDA has advised patients to purchase medicines only from licensed pharmacies and to obtain valid tax invoices. Consumers have also been advised to be cautious about suspicious packaging and QR or scanning codes that do not work.
- Authorities are continuing to trace the suspected supply chain and determine whether any of the medicines reached hospitals, clinics, pharmacies or patients.
Business Galaxy: The cancellation and suspension of licences are confirmed regulatory actions. However, allegations concerning individual establishments and the authenticity or composition of specific medicines remain subject to the ongoing investigation and laboratory testing.
