FDA seizes unlicensed medical devices worth over Rs 1 crore from GT Hospital

"It was found that one Vineet Tukaram Pimpale was operating from the premises in the name of M/s. Medicol Surgical & Hospital Equipment. The firm was operating without license. Stock of various orthopedic implants, including Intramedulary Nails and Interlocking Bolts were seized from the premises," the senior IAS official said.

The investigation revealed that the stock was purchased from a firm at Nanded, he said.

"An FDA team raided the premises of M/s Asclepious Enterprises, Ganesh Nagar, Nanded. The firm was not holding licenses for stock and sale of medical devices. Various orthopedic implants, worth Rs 1.07 crore were seized from the premises.

"The medical devices seized include Acetabular Cups, Shoulder Prosthesis rods, Muller Stem, Biopolar Hip Cross, Cancellous, Angle Radius, Poesteriomedial Tibia, Distal Tibia Nails, Cortex, Platonic Stem, Syrus Femur Nails, etc. These devices include some sterile implants to be used in orthopedic operations.

"The implants are used in Hip Replacement surgeries, Hip Joints procedures, fractures, etc. Despite operating without licence M/s Asclepious Enterprises was appointed as authorized dealer for Maharashtra by manufacturers namely M/s. Sharma Surgical & Engineering Pvt. Ltd., Vadodara, Gujarat and Orthotech Implants with Confidence, Valsad, Gujarat.

"Since the devices are manufactured at Gujarat, the team of FDA, Maharashtra is likely to go to Gujarat for further investigations," Kamble said.

This is the first time such a big raid has been carried out by FDA, he said.

"Rules prohibit stock, distribute and sale of the medical devices, except under licence issued under Drugs and Cosmetics Rules, 1945. This offence attracts penalty of imprisonment of 3 to 5 years and fine of minimum Rs 1 lakh, he said.

"Investigation revealed that this firm was selling these implants to about 22 various stockiest in Maharashtra. I have issued directions to all Joint Commissioners to carry out checks accordingly. Further investigation is in progress. Samples are being sent to ascertain the quality of the implants," he said.