Industry representatives said the incidents of substandard drugs highlight the need for stronger oversight, transparency, and independent auditing of testing laboratories.
Published Nov 11, 2025 | 7:00 AM ⚊ Updated Nov 11, 2025 | 7:00 AM
Drugs. (iStock)
Synopsis: Karnataka is planning to launch a third-party drug quality testing mechanism under the Quality Council of India to strengthen checks on medicines sold in the market. The move, following a representation by pharmacists, comes at a time when India’s drug regulatory system is under scrutiny following repeated reports of substandard and contaminated medicines.
Reports indicate that Karnataka is planning to launch a third-party drug quality testing mechanism under the Quality Council of India (QCI) to strengthen checks on medicines sold in the market, in what could become the first model of its kind by a state government.
The initiative aims to bring in an independent assessment of drug samples and eventually make such certification mandatory, according to officials of the Health and Family Welfare Services Department.
The move, following a representation by pharmacists, comes at a time when India’s drug regulatory system is under scrutiny following repeated reports of substandard and contaminated medicines, including the recent deaths of children linked to cold syrup consumption in Tamil Nadu’s Kanchipuram and Madhya Pradesh.
Industry representatives said these incidents highlight the need for stronger oversight, transparency, and independent auditing of testing laboratories.
In a letter to the health department, the Bangalore District Chemists and Druggists Association called on the QCI to oversee an independent drug testing mechanism to verify medicines before they reach the market.
The association said in the letter that such a move would “restore public confidence in drug safety” and “help curb the growing menace of counterfeit and contaminated formulations”.
It noted that the absence of uniform, external testing standards had created a gap in accountability across the supply chain. The association also requested the formation of a special task force to trace and act against counterfeit medicines circulating in retail and wholesale markets.
Speaking to South First, Bangalore District Chemists and Druggists Association President B Thirunavukkarasu said that, though the association has written to Principal Secretary (Health & Family Welfare) Harsh Gupta regarding the proposal, they have yet to receive a response.
“We have sent our representation to the department seeking clarity on implementing the QCI mechanism, but no reply has come so far,” he said.
Earlier, speaking about the initiative, Harsh Gupta said the state is exploring voluntary third-party inspections for drug manufacturers after its earlier proposal to establish an independent testing body faced procedural challenges.
He noted that the framework would mirror certification models used in sectors such as construction, jewellery, and finance, and could become mandatory once the Centre amends the Drugs and Cosmetics Rules.
Thirunavukkarasu said Karnataka’s drug testing and enforcement systems face “serious structural flaws,” including a shortage of inspectors and under-resourced laboratories. “Several regulatory posts remain vacant, and some test reports are even being compromised over WhatsApp,” he said, referring to what he described as weak internal supervision.
He added that the problem was not limited to isolated incidents but reflected deep gaps in how drugs are monitored after manufacturing.
Many testing laboratories lacked modern equipment or trained analysts, leaving room for compromised results and unchecked distribution. “When there are no inspectors to check quality, how can we ensure what reaches the public is safe?” he said.
Thirunavukkarasu warned that the spread of counterfeit and substandard medicines was “eroding India’s reputation as the pharmacy of the world.”
He argued that India’s global credibility depended on ensuring rigorous quality checks domestically, not just for exports. “Our generics reach every part of the world, but our reputation suffers whenever such contaminated batches surface,” he said.
The association’s letter urged the government to create a separate post for drug control headed by a senior official, preferably an IPS officer, instead of combining the roles of food safety and drug administration.
“For the drug administration, there should be a post created that is headed by an IPS officer,” Thirunavukkarasu said, adding that stronger administrative authority would help restore discipline and public confidence in enforcement.
He also reiterated that every batch of medicine should be audited by a third-party certifying agency. Drawing a comparison, he said, “For gold ornaments we have BIS, for utensils ISI — why not a similar quality mark for medicines?”
The proposed QCI-led testing, he said, would provide a neutral verification layer between manufacturers and regulators, reducing the risk of internal compromise.
Raising concerns about unregulated online sales, Thirunavukkarasu termed the distribution of counterfeit medicine a form of “national public health terrorism.” He said e-commerce and instant-delivery platforms were worsening the problem as “the origin of medicines sold online cannot be traced”.
He also pointed to the lack of coordination between central and state drug regulators, adding, “The central agency blames the state, the state blames the Centre — and the consumer pays the price.”
(Edited by Muhammed Fazil.)
