The government is planning to introduce amendments to the Drugs and Cosmetics Act, 1940 which will provide compensation to patients if they are sold a faulty medical device by a manufacturer or importer. The decision has been taken in the backdrop of the uproar caused earlier this year in India and abroad over defective hip implants from US-based Johnson & Johnson.
The proposal to reimburse people affected by faulty medical devices will be taken up at the Drug Technical Advisory Board (DTAB), scheduled a week from today, Business Standard reported while quoting sources. If the proposed amendments get the green flag from DTAB, they will be tabled before the health ministry for approval. While in a nascent stage, a decision could be taken on the proposal by the end of this fiscal, the report added.
While some stakeholders believe amending the Drugs and Cosmetics Act to include compensations is a quick and much-needed step, others have called for compensations to be governed by a separate Act altogether, the daily reported.