Cough syrup deaths: Rajasthan govt suspends drug controller, halts distribution of Kaysons Pharma medicines
Cough syrup deaths: The state govt has reaffirmed its earlier advisory, while the Drug Controller General of India clarified on Friday that cough syrup should typically be administered only to children over five years old, and must never be given to those younger than two under any circumstances.
The crisis over contaminated cough syrup in Rajasthan deepened as two more children from Sikar fell unconscious after consuming cough syrup prescribed by a local doctor. Both have been admitted to the ICU of Jaipur’s JK Lone Hospital in critical condition. According to their families, the children developed cough and cold on September 16 and were treated at Hatheeda Primary Health Centre, where they were prescribed a syrup containing Dextromethorphan. Shortly after taking the medication, both lost consciousness.
So far, three children in Rajasthan have died from suspected cough syrup toxicity, while two others remain under intensive care. Nine children have lost their lives in Madhya Pradesh.
Halt on Kaysons Pharma drugs amid quality concerns
The Rajasthan government has halted the distribution of all 19 medicines produced by Kaysons Pharma until further orders following concerns over drug quality. The state drug controller has been suspended for allegedly influencing the process of determining pharmaceutical standards. Government data revealed that since 2012, over 10,000 samples from Kaysons Pharma were tested, of which 42 failed to meet quality norms.
In light of these findings, the Union Government has reiterated its advisory that cough syrups containing Dextromethorphan should not be administered to children below four years of age.
State government acts: Drug controller suspended
In response to the series of child deaths, the Rajasthan government has suspended State Drug Controller Rajaram Sharma for allegedly influencing decisions related to drug quality standards. The Medical and Health Department has also stopped the distribution of all medicines manufactured by Jaipur-based Kaysons Pharma, pending investigation.
Officials confirmed that distribution of all cough syrups containing Dextromethorphan, a common cough suppressant, has been temporarily suspended across the state as a precautionary measure.
19 Kaysons Pharma drugs under suspension
Authorities said 19 medicines produced by Kaysons Pharma are now under suspension “till further orders.” The decision follows growing concerns over the safety of the brand’s products amid reports that samples of its cough syrup may have been contaminated.
According to Rajasthan Medical Services Corporation Ltd. (RMSCL) Managing Director Pukhraj Sen, over 10,000 samples from Kaysons Pharma have been tested since 2012, and 42 of them failed to meet quality standards.
CM orders probe; expert committee formed
Chief Minister Bhajanlal Sharma has ordered a high-level investigation into the matter and directed that swift and effective action be taken against those responsible. An expert committee will be formed to conduct an in-depth examination of the suspected adulteration incident and assess the safety of the affected products.
Health Minister Gajendra Singh has also instructed officials to enforce all necessary measures to protect public health and ensure accountability in the pharmaceutical supply chain.
Union advisory and new safety norms
Principal Secretary Gayatri Rathore stated that the Union Government had earlier issued an advisory in 2021 warning against the use of Dextromethorphan in children under the age of four. The state government has reiterated this advisory, while the Drug Controller General of India (DCGI) has clarified that the syrup should only be administered to children above five years—and never to those under two years of age.
Going forward, all drugs posing risks to children or pregnant women will be required to carry clear warning labels to strengthen consumer safety.
Health Ministry clarifies cough syrup quality findings in Madhya Pradesh
The Ministry of Health and Family Welfare issued a statement addressing quality concerns surrounding cough syrup linked to recent child deaths in Madhya Pradesh. The ministry confirmed that the Central Drugs Standard Control Organization (CDSCO) collected six samples during its investigation, and all were found free of Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination.
State and central-level testing results
Simultaneously, the Madhya Pradesh Food and Drug Administration (MPFDA) reported that out of 13 samples collected independently by its team, three were tested so far, all of which also tested negative for DEG and EG. However, following a request from the Madhya Pradesh government, the Tamil Nadu FDA collected samples of Coldrif Cough Syrup from the manufacturing unit of M/s Sresan Pharma in Kanchipuram, Tamil Nadu.
The test results for these samples, received on September 3, 2025, revealed that they contained Diethylene Glycol beyond the permissible limits, indicating possible contamination at the manufacturing source.
Pan-India inspection and ongoing investigation
In response, risk-based inspections have been launched at the manufacturing sites of all 19 drugs linked to this case, spanning six states across India. These inspections are part of a broader national effort to ensure product safety and compliance with pharmaceutical standards.
Meanwhile, a multidisciplinary expert team comprising representatives from NIV, ICMR-NEERI, CDSCO, and AIIMS Nagpur continues to examine additional samples and environmental factors to determine the exact cause of the deaths reported in and around Chhindwara, Madhya Pradesh. The government reaffirmed that findings from these parallel investigations will shape the next course of regulatory and public health action.
Wider action: Tamil Nadu halts production of Coldrif syrup
In a related development, the Tamil Nadu Drugs Control Department has issued an immediate stop-production order to the manufacturer of Coldrif cough syrup after laboratory tests found a batch contaminated with Diethylene Glycol, a toxic chemical linked to multiple international cough syrup poisoning cases.
Deputy Director S Gurubharathi said that a show-cause memo has been served to the manufacturer and steps have been initiated to cancel its manufacturing license pending inquiry.
With deaths now reported in both Rajasthan and Madhya Pradesh, totalling at least 11 child fatalities, nationwide scrutiny of cough syrup manufacturing practices has intensified, prompting urgent reviews of pharmaceutical standards, testing procedures, and labeling norms.