The Maharashtra Food and Drug Administration (FDA) has filed a case in the civil court against a Mumbai-based wholesaler for illegal sale of orthopaedic implants to 22 stockists in the state without a valid license. The state regulator suspects this as part of a larger cartel working in the state.
Selling or stocking of medical devices is prohibited under Section 18(c) of Drugs and Cosmetic Rules except under licence.
“We have lodged the case in the court and are waiting to hear from the court on the matter. Maharashtra FDA had flagged the issue to the central government towards effectively regulating such practices of illegal stock and sale of high end medical devices through a stringent regulatory framework. Now with the coming up of the new medical device rules, more stringent action will be taken under the new set of rules by the DCGI,” explained Maharashtra FDA Commissioner Dr Pallavi Darade.
Illegal stocks of orthopaedic supplies and medicines were seized from a third-floor quarter in the government-run Gokuldas Tejpal Hospital in a major raid by the FDA almost a year ago. The FDA seized supplies worth over Rs.one crore from the hospital room and a firm in Nanded supplying medical instruments.
The raid was conducted in quarters given to doctors on the third floor of the residential building of the hospital. Accused Vineet Tukaram Pimpale was engaged in the illegal sale of orthopaedic implants such as interlocking bolts and intramedullary nails under the name ‘Medicol Surgical and Hospital Equipment'.
Supplier Ascelepious Enterprise in Nanded was also raided from where Pimpale bought supplies. Implants for hip joints, hip replacement surgery and fractures amounting to Rs.1.7 crore were seized from Nanded.
Pimpale was banned from selling medical supplies a few months ago to all four hospitals run under the JJ Group of Hospital as he had no licence.