Dinesh Gundu Rao flagged nine injectable drugs from out-of-state manufacturers after they failed sterility tests in Karnataka laboratories. In a letter to Union Minister JP Nadda, he urged that these companies be prohibited from selling any more drugs until they undergo inspection by the Central Drugs Standard Control Organisation (CDSCO) for compliance with Good Manufacturing Practices (GMP).
Published Feb 22, 2025 | 7:00 AM ⚊ Updated Feb 22, 2025 | 9:44 AM
Synopsis: Karnataka Health Minister Dinesh Gundu Rao has flagged nine injectable drugs from out-of-state manufacturers for failing sterility tests, raising concerns over patient safety. His letter to the Union Health Minister calls for an immediate nationwide recall of these drugs, urging the Centre to enforce stricter quality controls. While the state government blames regulatory gaps at the national level, public health experts argue that Karnataka must first strengthen its own drug procurement and testing systems to prevent further tragedies.
With the memory of recent maternal deaths in Karnataka’s Ballari district—allegedly due to the administration of contaminated injectables—still fresh, the Karnataka Health Minister Dinesh Gundu Rao, on Friday, 21 February, announced that nine injectable drugs manufactured in other states had failed sterility testing in the state’s laboratories.
In a letter to Union Health Minister J P Nadda, Rao wrote, “Between 1 January 2025 and 16 February 2025, nine injectable drugs manufactured in other states failed sterility testing in our state government laboratories.”
I have written to Union Health Minister Shri @JPNadda regarding the repeated instances of contaminated injectable drugs from other states being sold in Karnataka. It is deeply concerning that unsafe medicines have entered our healthcare system, leading to tragic incident of loss… pic.twitter.com/ku7T5aampA
— Dinesh Gundu Rao/ದಿನೇಶ್ ಗುಂಡೂರಾವ್ (@dineshgrao) February 21, 2025
The letter highlights a grave healthcare crisis—contaminated injectable drugs entering Karnataka from other states, putting countless lives at risk.
Drug advocacy groups and public health experts argue that in a country where injectable medications are often used in critical care settings, this failure is not just an administrative lapse—it is a matter of life and death. They say the state cannot simply “pass the buck to the centre and wash their hands of it.” Instead, they expect the Karnataka government to implement its own robust screening mechanisms.
The letter lists the names of nine drugs that failed sterility testing and states that the list does not include numerous injectables manufactured by Paschim Banga Pharmaceuticals, based in West Bengal, whose contaminated injectables allegedly caused the deaths of five young mothers in Ballari.
Karnataka Health Minister Dinesh Gundu Rao wrote that he has instructed the health department to take necessary steps to ensure these drugs are no longer sold in Karnataka. However, he expressed concern that “it is highly likely that other contaminated drugs manufactured by these companies are being sold in other states in India.”
He warned that injectables are used in acute care and pose a high risk to patients. “Given the life-or-death consequences for patients being administered these contaminated drugs, I request you to use your good offices to ensure that all products sold by these companies are withdrawn from the market across India,” he wrote.
He stated that these companies should not be allowed to sell any more drugs until they are inspected by the Central Drugs Standard Control Organisation (CDSCO) for compliance with Good Manufacturing Practices (GMP).
Meanwhile, he urged the ministry to establish a system for all state and central laboratories to share alerts with each other regarding drugs that have failed quality testing, particularly those that could cause serious adverse effects for patients.
“In addition to sharing alerts with each other, there should also be a legal requirement to share sales records from the manufacturer to enable the seizure of contaminated drugs from the supply chain before they are dispensed to patients,” the letter stated.
The minister also called for a system to alert doctors, pharmacists, and patients about drugs that fail testing in state laboratories.
According to experts, State Drug Control Departments in India are not entirely helpless, but they face significant limitations due to the country’s centralised drug regulatory framework, which places key powers under the Central Drugs Standard Control Organisation (CDSCO).
Under the Drugs and Cosmetics Act, 1940, both central and state governments share responsibility for drug regulation. States have the authority to issue licences for the manufacture, distribution, and sale of drugs within their borders. They are also responsible for inspecting manufacturing units, pharmacies, and distribution centres within their jurisdiction.
Additionally, state authorities conduct routine sampling and testing of drugs available in the market through state-approved laboratories. They have the power to seize drugs found to be substandard, adulterated, or misbranded. States can also take legal action against violators by imposing fines, suspending licences, and initiating criminal prosecutions under the Act.
If a contaminated drug is detected, states have the authority to ban its sale within their territory and initiate recalls from pharmacies and hospitals.
Despite these powers, state drug control authorities face several challenges.
Karnataka Health Minister Dinesh Gundu Rao, in an earlier interview with South First, said, “States can only regulate and take action against manufacturers within their territory. If contaminated drugs originate from another state, the affected state cannot directly act against the manufacturer—this power lies with the CDSCO and the state where the manufacturer is based. Also, there is no formal mechanism for states to share data on failed drug tests or coordinate actions across state borders.”
This lack of coordination causes delays in recalling drugs from the market nationwide. Only the CDSCO can order a nationwide recall, inspect out-of-state manufacturing facilities, or enforce Good Manufacturing Practices (GMP) across the country. This dependency often results in bureaucratic delays, particularly when urgent action is required, he added.
While states face constraints, they are not powerless. Speaking to South First, Dr Gopal Dabade, President of the Drug Action Forum, Karnataka, criticised the state government, stating that instead of addressing systemic failures within Karnataka, “the health minister is more concerned about the CDSCO than about what is happening in his own state.”
He pointed out that while central oversight is crucial, glaring lapses within Karnataka’s own systems demand immediate attention. The Karnataka State Medical Supplies Corporation Limited (KSMSCL), responsible for procuring medicines for public healthcare facilities, has clearly failed in its primary duty—ensuring the safety and quality of drugs before distribution.
Dr Dabade argued that the contaminated intravenous fluids (IVFs), particularly Ringer Lactate, linked to the tragic deaths of young mothers in Ballari district hospital, should never have reached healthcare providers. He attributed this failure to KSMSCL’s reliance on random sampling for quality checks, a system that is grossly inadequate for high-risk medications like injectables.
Dr Dabade highlighted how proactive state governments like Tamil Nadu, Rajasthan, and Kerala have implemented far more stringent protocols.
“Every drug batch arriving at district warehouses is quarantined until it clears comprehensive quality testing. This ensures that no drug reaches patients without thorough verification of its safety and efficacy,” he explained.
Why hasn’t Karnataka adopted this proven model? Despite evidence of its effectiveness in other states, there appears to be a lack of urgency—or perhaps reluctance—from both KSMSCL and the state health authorities.
The Drug Action Forum–Karnataka and Sarvatrika Andolana recently held a jaatha (public rally) across nine districts—Bidar, Gulbarga, Raichur, Koppal, Ballari, Davangere, Tumkur, Kolar, and Chintamani—before concluding in Bengaluru on 14 February 2025. The rally received overwhelming public response, and several critical failures were brought to the forum’s attention.
Dr Dabade argued that instead of addressing these glaring gaps in drug procurement and distribution, the health minister’s focus on writing to the central health ministry seems like an attempt to shift responsibility.
“While highlighting the failures of manufacturers in other states is valid, it conveniently diverts attention from Karnataka’s internal mismanagement. The real question the minister should answer is: Why hasn’t KSMSCL been held accountable for allowing unsafe drugs to reach hospitals? Instead of directing public attention to national-level interventions, the state government should prioritise cleaning up its own system to prevent further loss of lives due to administrative failures.”
Dr Sylvia Karpagam, a public health expert, also raised serious concerns about the sale of contaminated injectable drugs, particularly essential medicines such as antibiotics and life-saving drugs like atropine, furosemide, and dextrose.
“It is shocking and completely unacceptable that a patient in an emergency could receive drugs that put their life at even greater risk. This also places treating doctors in danger of being unfairly blamed for complications arising from contaminated drugs,” she said.
While she appreciated Karnataka’s health minister for recognising the problem and proposing preventive measures, she questioned why proper systems were not already in place.
“Why are random samples from manufacturers not being tested and made public? Why do patients—particularly mothers—have to die before the government takes action? Even after these tragedies, why hasn’t there been a proactive response to prevent future incidents? These are basic responsibilities of an elected government, and it is deeply concerning that they are not being fulfilled,” she added.
Interestingly, the Not of Standard Quality (NSQ) alert for January 2025, published on the Central Drugs Standard Control Organisation (CDSCO) website, has flagged Amikacin Sulphate Injection IP 250 mg, manufactured by Karnataka Antibiotics and Pharmaceuticals Limited (KAPL), Peenya, Bengaluru. This finding was reported by the Central Drugs Laboratory in Kolkata.
KAPL, a joint venture between the Karnataka government and the Government of India, has been implicated in producing NSQ antibiotics used in acute care settings. Historically, KAPL has faced multiple failures due to NSQ classifications for its drugs. Given these repeated violations, it is imperative for the Karnataka government to address regulatory failures within its own pharmaceutical sector.
Dr Gopal Dabade argues that if Karnataka truly wants to prevent such tragedies in the future, immediate reforms are needed. He emphasises that the state should look to Tamil Nadu’s model of effective drug regulation for inspiration.
Tamil Nadu’s Medical Services Corporation (TNMSC), similar to Karnataka’s, conducts strict pre-procurement audits, ensuring that all manufacturers comply with Good Manufacturing Practices (GMP) before their drugs enter the state supply chain.
The drug control department in Tamil Nadu also conducts frequent random testing of drugs, including those procured from outside the state, to detect potential contamination at an early stage.
A well-integrated alert system notifies healthcare providers and pharmacies in real time when substandard drugs are detected, allowing for immediate withdrawal from circulation.
Meanwhile, Tamil Nadu swiftly blacklists manufacturers and distributors who fail quality tests, barring them from future tenders until they meet all regulatory requirements.
Dr Dabade suggests that Karnataka must adopt the following measures:
(Edited by Dese Gowda)
