Karnataka, Telangana, Kerala and Andhra Pradesh have launched strict surveillance, inspections, and public awareness campaigns, with Kerala forming an expert committee to issue child-specific guidelines.
Published Oct 06, 2025 | 7:36 PM ⚊ Updated Oct 06, 2025 | 8:33 PM
Drug control officials inspect a pharmacy in Anakapalle town, Andhra Pradesh, on Monday. (Supplied)
Synopsis: Four southern states—Karnataka, Telangana, Kerala and Andhra Pradesh—have banned the prescription and sale of cough and cold medications for children under two following the deaths of at least 16 children in Madhya Pradesh and Rajasthan from contaminated Coldrif syrup containing toxic diethylene glycol. States have launched strict surveillance, inspections, and public awareness campaigns, with Kerala forming an expert committee to issue child-specific guidelines, while Karnataka and Telangana emphasised non-pharmacological treatment and procurement only from GMP-compliant manufacturers.
Karnataka, Kerala, Telangana and Andhra Pradesh have banned the prescription and sale of cough and cold medications for children under two, following the deaths of at least 16 children in Madhya Pradesh and Rajasthan after consuming contaminated cough syrup in September.
The syrup, Coldrif, was allegedly adulterated with Diethylene Glycol (DEG), a highly toxic substance. Laboratory reports from Madhya Pradesh and Tamil Nadu confirmed the presence of DEG in alarming concentrations: 46 percent in the Madhya Pradesh report and 48.6 percent in the Tamil Nadu report. The permissible limit for DEG is just 0.1 percent.
The contaminated Coldrif syrup (Batch No SR-13, manufactured in May 2025 with expiry in April 2027) was made by Sresan Pharma in Sunguvarchathiram, Kancheepuram district, Tamil Nadu. It was distributed to Rajasthan, Madhya Pradesh, Puducherry and Odisha. Rajasthan also reported deaths linked to Dextromethorphan Hydrobromide Syrup manufactured by Jaipur-based Kaysons Pharma.
Following these incidents, the Directorate General of Health Services (DGHS) issued a nationwide advisory on 3 October, stating that “cough and cold medications should not be prescribed or dispensed to children under 2 years” and are “generally not recommended for ages below 5 years.”
Karnataka and Telangana quickly implemented the central advisory, issuing orders to healthcare providers across government and private institutions.
Both states explicitly prohibited the prescription or dispensing of cough and cold syrups to children below two, with strict guidance for older age groups.
The Director of Health & Family Welfare Services, Karnataka, issued detailed instructions on 6 October for strict compliance across all healthcare institutions.
“Cough and cold syrups should not be prescribed or dispensed to children below 2 years of age. For children between 2 to 5 years of age, such medications should generally be avoided, unless clearly indicated and prescribed after proper clinical evaluation,” the order stated.
Karnataka’s directive added that for older children, cough syrups should be used only after thorough clinical assessment, in the lowest effective dose and for the shortest duration. It specifically warned against fixed-dose multi-drug combinations, oral bronchodilators and cough suppressants.
Telangana’s Director of Public Health & Family Welfare issued similar instructions, directing all District Medical and Health Officers (DM&HOs) to enforce and disseminate the advisory across government and private facilities.
“Most acute cough illnesses in children are self-limiting and often resolve without pharmacological intervention. Cough and cold medications should not be prescribed or dispensed to children under 2 years. These are generally not recommended for ages below 5 years,” the Telangana order stated.
The directive also noted that any use of cough medicines for children above five should follow careful clinical evaluation, close supervision, correct dosing, the shortest effective duration, and avoidance of multiple drug combinations.
Kerala has taken a distinctive approach by constituting a three-member expert committee to study the use of cough medicines in children. The committee has handed over a preliminary report.
The panel includes the State Drugs Controller, the Child Health Nodal Officer, and the president of the Indian Academy of Paediatrics (IAP) Kerala chapter.
Health Minister Veena George, after chairing a high-level review meeting in Thiruvananthapuram, said the state would issue a separate set of guidelines for the use of cough medicines in children based on the committee’s findings.
“Medicines should not be given to children even with an old prescription. The dosage is determined by doctors according to the child’s weight. Giving a medicine prescribed for one child to another can cause more harm than good,” George cautioned.
Emphasising the risks of self-medication, she warned parents and caregivers against giving medicines to children below 12 years without a valid prescription from a recognised doctor.
The minister directed the Drugs Controller to ensure strict compliance with this instruction and said public awareness campaigns would be strengthened to educate parents about the safe use of medicines for children.
Doctors who attended the Kerala review meeting said no health issues related to cough syrup have been reported among children in Kerala so far. However, the health department has instructed a detailed check to confirm this and will conduct training sessions for paediatricians and other doctors in collaboration with IAP to enhance awareness and vigilance.
Karnataka and Telangana have stressed the importance of non-pharmacological measures as the first-line approach to treating cough and cold symptoms in children.
Karnataka’s order stated: “Non-pharmacological measures such as adequate hydration, rest, supportive measures and nutritious diet should be encouraged.”
Telangana’s directive similarly said: “Non-pharmacological measures, including adequate hydration, rest, supportive measures should be the first-line approach.”
Karnataka’s comprehensive order also required all healthcare providers to follow the Standard Treatment Protocols and Therapeutic Guidelines issued by the Ministry of Health and Family Welfare, as well as the Integrated Management of Neonatal and Childhood Illness (IMNCI) guidelines for managing cough and respiratory symptoms in children.
Karnataka and Kerala launched aggressive inspection drives to track any contaminated batches within their borders. Karnataka’s Additional Drugs Controller & State Licensing Authority instructed all enforcement officers to monitor Coldrif Syrup Batch No SR-13 and Dextromethorphan Hydrobromide Syrup from Kaysons Pharma.
“All Enforcement Officers in the state of Karnataka are hereby instructed to keep a strict vigil on the above drugs/batch number and same combinations from manufacturers. Any stockist/distributor/retailer/Government Institutions, who are in possession of these products, if any, should draw samples for test and analysis, then necessary action has to be initiated as per Drugs and Cosmetics Act, 1940,” the Karnataka order stated.
The Commissioner of Food Safety & Drug Administration, Karnataka, also asked all District Health Authorities, medical institutions, government hospitals, PHCs and CHCs to recall these drugs if found, under intimation to the concerned jurisdictional Assistant Drugs Controller Office.
Kerala conducted inspections across the state under the Drugs Control Department. Following reports of contamination in the SR-13 batch of Coldrif syrup outside Kerala, the sale of the product was halted within the state. Officials confirmed that neither of the faulty batches was sold in Kerala. Coldrif is sold in the state through eight distributors, and their distribution and sale have been suspended as a precautionary measure.
Telangana’s Director of Public Health & Family Welfare informed District Medical and Health Officers that the Director General Drug Control Administration, Telangana, had issued a press note urging the public to immediately stop using Coldrif Syrup, Batch No SR-13. The directive included a toll-free number (1800-599-6969) for the public to report possession of the contaminated batch to the local drug control authority.
Both Karnataka and Andhra Pradesh moved quickly to reassure parents that the contaminated cough syrup had not been supplied to their states. Karnataka Health Minister Dinesh Gundu Rao said on Monday:
“Today, Karnataka has become a model for the country, with no room for lapses. I assure the parents that it has not been supplied in our state. We have started testing samples of other cough syrups as a precautionary measure, and our department will release guidelines for parents today.”
Andhra Pradesh Health Minister Satyakumar Yadav similarly clarified that the adulterated cough medicine that led to deaths in Madhya Pradesh and Rajasthan was not supplied to the state from the company. Minister Yadav was briefed on the latest developments by State Health and Family Welfare Commissioner Veerapandian, State Drug Control Administration-in-Charge Director General Girisha, and APMSIDC MD Girisha.
“Drug inspectors did not find any evidence of the supply of cough medicine from the said company to the drug shops during their inspections. No invoices were found with the shops showing that the cough medicine was distributed from the said company. No boxes of cough medicine were found in the shops. The series of inspections by drug inspectors is still going on,” Director General (DCA) in-charge Girisha stated.
Girisha added:
“There is no adulterated medicine from the company in the medicines purchased for supply to government hospitals. We use cough medicines from four different companies in the state. Our company is distributing single molecule syrup to government hospitals instead of combination formulations. In the states of Madhya Pradesh and Rajasthan, a company from Kancheepuram (Sresan Pharmaceuticals) supplied ‘Coldif’ cough medicine in combination form.”
Karnataka and Telangana emphasised the importance of procuring medicines only from Good Manufacturing Practice (GMP)-compliant licensed manufacturers.
Karnataka’s order stated: “All healthcare facilities shall ensure procurement of products only from Good Manufacturing Practice (GMP)-compliant licensed manufacturers.”
Telangana’s directive similarly said: “All healthcare facilities and clinical establishments must ensure procurement and dispensing of products manufactured under Good Manufacturing Practices and formulated with pharmaceutical-grade excipients. Sensitisation of prescribers and dispensers across public and private sectors is essential to uphold these standards of care.”
Karnataka Health Minister Dinesh Gundu Rao called for a centralised system to share information about substandard medicines across states. “A website would enable all states to stay informed about such incidents, regardless of where they occur. We are urging the Central Government to launch this platform to ensure better coordination and safety,” Rao stated on X.
Karnataka also set up a robust surveillance mechanism requiring mandatory reporting of adverse events. “Any adverse events or suspected cases of cough syrup-related toxicity or death, as well as any unusual or unexplained increase in incidence of cough amongst children or the community, must be promptly investigated and reported in the IHIP portal of the Integrated Disease Surveillance Programme (IDSP) Division, Directorate of Health & Family Welfare,” the order mandated.
The state warned of strict action against violators. “Violations of these instructions—including irrational prescription, over-the-counter sale, or use of unapproved fixed-dose combinations—will attract statutory action under the Karnataka Private Medical Establishments (KPME) Act, 2007, as well as under the Drugs and Cosmetics Act, 1940 and Rules, 1945,” the order cautioned.
Telangana and Karnataka directed district and taluk health authorities to ensure wide dissemination of the advisory among paediatricians, general practitioners, pharmacists, and nursing staff. Karnataka noted that random inspections may be conducted to ensure compliance.
Andhra Pradesh State Health and Family Welfare Commissioner Veerapandian said:
“We have sent the instructions of the Director General of Health Services of India and instructed the district medical and health department officials to take steps to ensure that doctors take precautions. We have asked them to report on how these are being implemented at the field level. We have also instructed pharmacists to be made aware.”
The tragedy that claimed 16 young lives has prompted southern states into unprecedented coordinated action, transforming the landscape of paediatric care and medicine regulation in the region.
The affected children initially presented with mild fever and cold symptoms and appeared to recover, before their conditions suddenly deteriorated, with critical symptoms including complete cessation of urine output, persistent vomiting, facial and body swelling, and rapid progression to acute kidney failure—a grim reminder of the consequences of contaminated medicines.
