31,000 Oxytocin stored at room temperature seized in Delhi

The Delhi government’s Drugs Control Department has seized over 31,000 Oxytocin injections from a pharmaceutical premises in the Patparganj Industrial area after officials allegedly found them stored at room temperature, violating mandatory cold chain norms, officials said on Thursday.

The action occurred in east Delhi during a special inspection conducted under the department’s enforcement programme following directions from Delhi Health Minister Pankaj Kumar Singh.

According to the government, 31,700 Oxytocin injection IP 5 IU/ml vials were found stored at room temperature despite the product label specifying that the medicine must be stored between 2 and 8 degrees Celsius.

Officials said the stock had allegedly remained under such conditions since it was procured in May this year.

The Drugs Control Department said the storage did not comply with Rule 65(17) of the Drugs Rules, 1945.

Although a functional refrigerator was available at the premises, the department noted that no medicines requiring cold storage were found inside it. Officials said considering Oxytocin’s critical therapeutic use of and the possibility of deterioration in its potency due to prolonged improper storage, the department seized the entire stock under the provisions of the Drugs and Cosmetics Act, 1940.

The department also collected details of supplies already made from the batch to facilitate stop-sale and recall directions, wherever required.

Officials said further legal proceedings are being initiated under the Drugs and Cosmetics Act and Rules.

The Health Minister said the government has “zero tolerance” for compromising with the quality, safety and efficacy of medicines.

“The Delhi Government is firmly committed to ensuring that every medicine available to the public meets the highest standards of quality, safety and efficacy. Any violation that compromises patient safety, particularly involving critical medicines, will invite strict legal action,” he said.

The minister said he directed the Drugs Control Department to intensify inspections across the national capital and take stringent action against violators.

He said enforcement drives and surprise inspections would continue to ensure compliance with the Drugs and Cosmetics Act and Rules and safeguard public health.