FDA seizes Orthopaedic implants worth Rs 1.4 crore

26 February 2017

PUNE: In a huge crackdown on illegal sale of orthopaedic implants, Food and Drug Administration (FDA) officials have seized stock worth Rs 1.40 crore from various distributors in Pune, Solapur, Satara and Kolhapur in just two weeks since February 10.

An investigation into the illegal implant industry began after the FDA uncovered a racket operating from the premises of GT hospital in Mumbai on February 2. Since then, a series of raids have been conducted across the state, leading to a seizure of Rs 7 crore worth of orthopaedic implants being sold illegally through a nexus of manufacturers, distributors and hospitals.

In all these cases, it has been found that the distributors supplying these implants to hospitals did not possess the mandatory licences.

"We have inspected the implant stock at several hospitals in Pune division. But, we didn't not come across any instance of the involvement of the hospitals in the illegal trade, so far. However, we have found quite a few distributors who were operating the business of orthopaedic implants without seeking mandatory licence from the FDA. This is illegal and attracts prosecution," Vidyadhar Jawadekar, joint commissioner (drug), FDA, Pune division, told.

"A criminal case will be filed against the erring distributors in court for violating the norms," he said. Doctors from the city, however, said there had been little awareness among medical practitioners about various provisions of the Drug and Cosmetics Act.

"We are aware of the fact that the implant and prosthetic manufacturing and trade has come under the purview of the Drugs and Cosmetics Act. However, provisions of the Act are still not known to common orthopaedic surgeons. The FDA should communicate to the national, state and district associations of orthopaedic surgeons about conducting awareness camps to sensitize doctors about the provisions of the Act," orthopaedic surgeon Nitin Bhagli had said in an earlier interview.

Bhagli is the chairman of the Indian Medical Association's Hospital Board of India, Pune branch, and executive member of the Maharashtra Orthopaedic Association.

The state-wide drive to detect illegal sale of orthopaedic implants was kicked off on February 10, three days after illegal implants were seized in Mumbai on February 7.