Govt gets ready to amend rules to hold manufacturers accountable for faulty medical devices

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The Central government is getting ready to introduce a legal provision to make pharmaceutical firms liable to pay compensation for injuries caused to consumers by their faulty products.

According to industry sources, the move to amend the Drugs and Cosmetics Act is aimed at preventing incidents similar to the Johnson & Johnson (J&J) faulty implant case in future. As per the current regulations, companies pay compensation only in case of adverse events during a clinical trial.

The proposed provision will help the government plug gaps in the existing rules. The absence of such a law has made it tough for regulators to seek compensation from J&J for patients who had undergone faulty hip implant surgeries.

The Central Drug Standards Control Organisation (CDSCO), the national pharmaceutical regulatory body, is learnt to have proposed changes in the existing law to introduce a compensation provision for approved drugs and medical devices that have an adverse impact on a patient.

As many as 4,700 patients in India received acetabular surface replacement hip implants manufactured by J&J offshoot DePuy Orthopaedics between June 2004 and August 2010, until a global recall over concerns that the metallic implants could leak toxic cobalt and chromium into patents’ bodies.

An expert panel constituted by the government to look into the issue has acknowledged in its report that there is no provision as such for compensation to patients for faulty medical devices in the D&C Act, only fines and prosecution which can be initiated by the drug inspector or consumer associations, not patients.

In its report, the panel also observed that DePuy “appeared to have suppressed certain facts about the implants” from Indian regulators. It recommended that eligible patients should receive a “base amount” of Rs. 20 lakh as compensation, and proposed mechanisms to identify eligible patients.

Source: 1

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