World · India Bureau
Drug regulator revokes 16 pharmacy licenses in crackdown on illegal repackaging
India's pharmaceutical regulator has cancelled 16 pharmacy licenses and suspended eight others, including a Pfizer distribution depot, following investigations into an unlicensed drug repackaging operation discovered in Karnataka.
LSN India ·
The Food Safety and Drug Administration (FSDA) has intensified its enforcement action against illegal pharmaceutical practices, revoking licenses for 16 pharmacies while placing temporary suspensions on eight operations, including a distribution facility for multinational company Pfizer. The sweeping regulatory action stems from an investigation into a sophisticated drug repacking and relabeling scheme uncovered at a farmhouse in Bidadi, Bengaluru South district, on August 18.
The operation, which authorities described as large-scale, involved the unauthorized repackaging and relabeling of pharmaceutical products—a practice that poses serious public health risks by compromising product authenticity and traceability. Investigations revealed that the facility was operating without proper licensing, raising concerns about the integrity of medicines that may have entered the supply chain.
The FSDA's action reflects heightened scrutiny of the pharmaceutical distribution network in Karnataka, a major hub for drug manufacturing and distribution in India. The regulator's dual approach—permanent revocation for the most serious violations and temporary suspension for others—indicates an escalated enforcement strategy to clean up the sector.
The case underscores the challenges Indian regulators face in combating pharmaceutical counterfeiting and illegal repackaging operations. Authorities have indicated that the investigation remains ongoing, with potential for further action as evidence is analyzed and supply chain connections are traced.