Karnataka seizes medical devices worth ₹13.79 lakh in Bengaluru over labelling violations
According to Karnataka Health Minister UT Khader, the department seized products worth ₹6,57,031 from Mandev Surgipharma Pvt Ltd and ₹7,21,590 from Shree Mandev Surgicals.
The Karnataka Drugs Control Department seized medical devices and consumables worth approximately ₹13.79 lakh from two establishments in Bengaluru’s Cottonpet area during a special enforcement drive on Wednesday, and Thursday, 11 and 12 November, after officers found multiple labelling irregularities.
The seized products included hearing aids, clinical and digital thermometers, surgical gloves, urine bags, medical compression stockings, glass slides, an otoscope and other medical devices. Several products were found without one or more mandatory label details, including batch numbers, manufacturing and expiry dates, manufacturer information, medical device licence numbers and maximum retail prices (MRP).
According to Karnataka Health Minister UT Khader, the department seized products worth ₹6,57,031 from Mandev Surgipharma Pvt Ltd and ₹7,21,590 from Shree Mandev Surgicals.
“Patient safety is non-negotiable. Every medical device entering the market must meet prescribed safety, quality and labelling standards. In a special enforcement drive on November 11 and 12, officers of the Drugs Control Department under our Health and Family Welfare Department seized medical devices and consumables worth approximately ₹13.79 lakh from two establishments in Bengaluru’s Cottonpet area,” Khader said.
Patient safety is non-negotiable. Every medical device entering the market must meet prescribed safety, quality and labelling standards.
In a special enforcement drive on November 11 and 12, officers of the Drugs Control Department under our @DHFWKA seized medical devices and consumables worth approximately ₹13.79 lakh from two establishments in Bengaluru’s Cottonpet area.
The seized products included hearing aids, clinical thermometers, surgical gloves, urine bags, compression stockings and other medical devices. Several products were found with one or more missing mandatory label details, including batch numbers, manufacturing and expiry dates, manufacturer details, licence numbers and MRP.
Samples have been collected and sent for testing. Further action will be taken strictly in accordance with the law. Such enforcement drives will continue, with strict vigilance against violations.
I urge the public to remain alert, purchase medical devices from authorised sellers and check batch numbers, expiry dates, manufacturer details and MRP before making a purchase.
Healthcare products must inspire confidence, not put patients at risk. Protecting public health and ensuring patient safety remain our foremost responsibilities.
The inspection records list several products sold by Mandev Surgipharma Pvt Ltd, including glass slides, hearing aids, varicose vein stockings, eye wash cups, otoscopes, clinical thermometers, medical compression stockings, disposable gloves, urine bags, digital thermometers, IUI cannulas and nasal splints.
The irregularities varied across products. Some lacked batch numbers and expiry dates, while others did not carry manufacturer details or medical device licence numbers. Certain products were also found without their MRP.
The inspection of Shree Mandev Surgicals also found labelling deficiencies in products such as an enema set and disposable sterile gloves. The records additionally list an oxygen fine adjustment valve and a uterine balloon tamponade among products with missing label information.
The department has collected samples and sent them for testing. Further action will be taken in accordance with the law, the minister said.
Khader urged consumers to buy medical devices from authorised sellers and check product labels before purchasing them.
“Several products were found with one or more missing mandatory label details, including batch numbers, manufacturing and expiry dates, manufacturer details, licence numbers and MRP. Samples have been collected and sent for testing. Further action will be taken strictly in accordance with the law,” he said.
The minister said enforcement drives would continue and called on consumers to check batch numbers, expiry dates, manufacturer details and MRP before buying medical devices.