NEW DELHI: Learning perhaps from the Johnson & Johnson hip implant fiasco, the Centre has for the first time taken a step to ensure monetary compensation to patients who suffer because of faulty medical devices and implants manufactured or imported by companies.The Drugs Technical Advisory Board, India’s apex drugs advisory body, has given a green signal to a proposal to amend the rules for medical devices to include provisions for compensation, government sources said.
“There is absolutely no compensation mechanism for patients suffering due to faulty medical devices as of now,” an official of the board said. “A committee has now been formed to look into various aspects, such as, in what specific cases the compensation be offered and what approach be adopted for that.”
The move comes at a time when Johnson & Johnson has been directed to compensate patients who suffered due to faulty hip implants supplied by it. This is the first time that a company is being made to pay for the faulty devices it sold. However, the government did not specify how the compensation figures were arrived at.
Malini Aisola of All India Drug Action Network — which fights for patients’ rights — welcomed the move to frame rules, but added that formulating a patient compensation policy had to be a consultative process and the policy meant for clinical trial patients should not be emulated blindly.“There are concerns with extending the clinical trial compensation rules to medical devices, especially when they are still being discussed with stakeholders,” she said.