NEW DELHI: The Centre, for the first time, has taken a step in the direction of ensuring monetary compensation to patients suffering due to faulty devices or implants by companies manufacturing or importing them.
Drugs Technical Advisory Board, India's apex drugs advisory body has given green signal to a proposal for amending the country's 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 and that is an area where the need for a strong regulatory framework is felt," an official attached with the body said.
"There has now been a committee formed to look into things such as in what specific cases the compensation be offered and what approach be adopted for that."
The move comes at a time when US medical device major Johnson and Johnson has been directed to compensate patients who suffered due to certain models of faulty hip implants supplied by it and its first such instance where a company is being made to pay for faulty devices it sold.
On Thursday, the government ruled that patients will get between Rs 30 lakh-1.3 crore by the company, depending on the degree of disability or death-but did not specify how the figures were arrived at.
Malini Aisola of All India Drug Action Network-which has been fighting for patients' rights-while welcoming the move said that formulating a patient compensation policy has to be a consultative process and the compensation 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. "Lack of transparency in deciding such crucial matter is not acceptable as what has just now happened in Johnson and Johnson case."