Third-party agency to conduct quality, safety checks at Karnataka pharmacies
The model is expected to mirror systems already in place in sectors such as construction and finance, where third-party quality certification is widely accepted.
Health minister Dinesh Gundu Rao told TOI that the govt plans to bring the Quality Council of India (QCI) — a central govt-backed public-private partnership — on board to conduct independent inspections of pharmacies. The move is aimed at curbing the supply of spurious and expired drugs and ensuring better compliance with safety regulations.
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"We plan to rope in QCI on a trial basis and proceed from there," Gundu Rao said. "If it's successful, then we will expand operations to the entire state. The move will help bring transparency in quality control and compliance checks." The health department intends to pilot the initiative in a single district.
However, a regulatory hurdle remains. Harsh Gupta, health secretary, said: "The state govt will move a proposal to the Centre to introduce third-party inspection of compliance to regulations and seek amendment to the Drugs Rules of 1945."
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If approved, Karnataka would become one of the first states to open pharmaceutical inspections to independent assessors — a move officials believe is necessary to keep pace with rapid growth of the sector.
Officials say relying solely on govt drug inspectors has proven ineffective due to the sheer volume of pharmacies in the system. "The biggest challenge is to get our drug inspectors to go to the field and conduct compliance and regulation checks. It is humanly impossible to do so," said a senior health department official. "If third-party inspections by private parties are allowed, this will ease the burden on our resources and also make it that much more hassle-free for pharmacies to secure and re-apply for licences.
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