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Karnataka govt seeks Union health ministry support in its Drug Recall Policy
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Nandita Vijayasimha, Bengaluru
March 12 , 2025
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Karnataka government is seeking the involvement of the Union government for its recall NSQ (not-of-standard) Drug Policy which is being formulated. The support is sought in establishing a more robust and coordinated drug recall policy. The objective is to stall distribution of substandard drugs, thereby safeguarding the health of the patients.
The policy is advocating for an effective recall system to ensure that substandard and expiry dated drugs are promptly removed from circulation.
The state government is also requesting an interstate portal to flag pharmaceutical companies that produce substandard drugs. This follows with the concerns over contaminated drugs. The state government has expressed serious apprehensions about the sale of contaminated medicines and specifically injectable drugs, particularly those manufactured in other states.
Recent incidents, including maternal deaths, have highlighted the urgency of this issue. Now the state government has requested the Union health ministry to take action to withdraw contaminated drugs from the market across India.
Karnataka sees the need to create a system for states and Central laboratories to share alerts about drugs that fail quality testing. They have also requested for a system where sales records are shared, so that not-of-standard quality drugs can be removed from the supply chain.
A key aspect of Karnataka's request is for improved collaboration and information sharing between states and the central government regarding drug quality. In this regard, we have sought the contribution of the Union government and the Drugs Controller General of India (DCGI), Karnataka health and family welfare minister Rao said.
To prevent the distribution of expired and substandard medicines the drug recall policy mandates inspections of labs and warehouses of suppliers who bid for government contracts, said Minister Rao during the legislative sessions.
The move comes in the wake of a series of fatalities of expectant mothers in the government hospitals and primary healthcare centres but especially in Bellari district resulting from the substandard Ringer lactate injections.
The emphasis on government hospitals and primary health centres highlights a commitment to ensuring that vulnerable populations have access to safe and effective medications.
The state has indicated a major focus on improving the quality and safety of pharmaceuticals within the government healthcare system. This will be by implementing vigorous inspections to ensure low quality or expired drugs do not reach the government hospitals and primary health centres.
This has made Karnataka to relook at its drug testing mechanism ensuring medicines are tested at the NABL certified labs before distribution to taluk and district hospitals including primary health centres.
Earlier the drugs were procured and distributed first and tested later at the local level. From now efforts are being made to enforce stricter procurement processes, enhanced quality control measures, improved storage and distribution systems, more rigorous inspection and monitoring. This is in an effort to keep the expired or infected drugs at bay.
Minister Rao said that now the State embarks on background checks of drug distributors by mandating the rights to inspect manufacturing plants during the tender period. So all labs of the companies from where the drugs are produced and supplied to the government will be under surveillance to ensure quality supplies.
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