Kids’ syrups to be sold only with prescription: FDA

The FDA has also directed all chemists and druggists to ensure that all drugs under Schedule H, H1 and X will be sold only with a doctor’s prescription as mandated in the Drugs and Cosmetics Rules, 1945

MUMBAI: In the aftermath of children’s deaths in Madhya Pradesh and Rajasthan after consuming Coldrif cough syrup, the Maharashtra government has barred the sale of children’s syrups without a doctor’s prescription. A circular to this effect was issued by the Food and Drugs Administration (FDA) on Tuesday.

Horizontal photo of unknown hand pouring liquid into spoon from little bottle with syrup, person caring about child lying in bed with flu and sore throat, being upset. Children and health concept.

The FDA has also directed all chemists and druggists to ensure that all drugs under Schedule H, H1 and X will be sold only with a doctor’s prescription as mandated in the Drugs and Cosmetics Rules, 1945.

“It has been directed to all the retailers that they should not sell the syrups for paediatric patients without a prescription from doctors,” states the circular issued by DR Gahane, drug controller, on Tuesday.

Schedule H lists prescription-only medicines that require a registered medical practitioner’s prescription to be sold over the counter. It requires pharmacists to maintain a sales record and preserve prescriptions, while Schedule H1, a more recent and restrictive classification, adds a boxed warning on drug labels and mandates three-year record-keeping for sales and prescriptions of specific drugs like certain antibiotics and anti-TB medications.

Schedule X lists addictive drugs, such as narcotics and psychotropic drugs with medicinal uses that require strict controls. These drugs must be stored under lock and key, and retailers must keep prescriptions for two years. Possession and storage require a special licence from the local drug controller.

FDA commissioner Rajesh Narvekar said the objective is to discourage people from medicating themselves. “Medicines need to be consumed only on the advice of doctors, who are experts in their field. They are not ordinary products that can be bought and used as per one’s own wish,” Narvekar told Hindustan Times.

The FDA circular has also urged people to report chemists found selling drugs without prescriptions. “Those not following the order will have to face strict action,” it said.

The circular was issued based on an advisory issued by the Ministry of health and family welfare against the backdrop of the recent children’s deaths.

Coldrif cough syrup, marketed by Sresan Pharmaceuticals in Kanchipuram, Tamil Nadu, has been in the news after its consumption allegedly led to the death of 16 children in Madhya Pradesh, due to suspected kidney infection. Late last week, the health ministry said samples of Coldrif were tested by state authorities and found to contain diethylene glycol (DEG) exceeding permissible limits. Diethylene glycol is a toxic solvent used in industrial products and can cause kidney impairment.