The Maharashtra Food and Drug Administration (FDA) is planning to prosecute Vineet Tukaram Pimpale for illegally operating, stocking and supplying orthopaedic implants from the premises of GT Hospital, Mumbai in the name of Medicol Surgical and Hospital Equipment without a license.
Stocks of various orthopaedic implants, including Intramedulary Nails and Interlocking Bolts were seized worth Rs.4 lakhs from the premises of GT Hospital following a raid led by Maharashtra FDA Commissioner Dr Harshadeep Kamble recently.
He said, “This is the first time such a big raid of such kind has been made by FDA and added that the Section 18(c) prohibits stock, distribute and sale of the medical devices, except under Licence issued under Drugs and Cosmetics Rules, 1945. This is an offence attracting penalty of imprisonment of 3 to 5 years and fine of minimum Rs.one lakh, as prescribed under Section 27(b)(ii) of the said Rules.”
Investigations revealed that this firm was selling these implants to about 22 various stockists in Maharashtra. FDA has issued directive to all joint commissioners to carry out checks accordingly. Further investigation is in progress and samples are being sent to ascertain the quality of the implants.
Based on interrogation of the accused and other leads, a team of assistant commissioners and drug inspectors of FDA, Nanded raided the premises of Asclepious Enterprises, Ganesh Nagar, Nanded and seized stocks worth Rs.1.07 crore of various orthopaedic implants, from the said premises.
The Medical Devices seized were 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 orthopaedic operations. The said implants are used in Hip Replacement surgeries, Hip Joints procedures, fractures, etc.
It was also revealed that despite having no licence, Asclepious Enterprises, Nanded, was appointed as an authorized dealer for Maharashtra by the manufacturers namely Sharma Surgical and Engineering Pvt. Ltd, Vadodara, Gujarat and Orthotech Implants, Valsad, Gujarat. Since the devices are manufactured in Gujarat, a team of FDA, Maharashtra is likely to go to Gujarat for further investigations.