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.
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.
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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.
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