Central Drugs Standard Control Organisation (CDSCO) has ordered Johnson and Johnson to pay compensation to the first patient who received faulty hip implants made by the firm.
Earlier,Government had set up a committee which provided details about the faulty hip prosthetics sold by a subsidiary of the U.S. firm Johnson & Johnson to Indian patients.It said that the company had suppressed key facts on the harmful effects of the company’s “faulty” hip replacement systems.It was withdrawn globally after complications which resulted in many patients undergoing revision surgery.
The Supreme Court had recently closed down the case seeking action against US-based pharma major Johnson and Johnson for implanting faulty hip implants into patients in India.The case was closed after Government informed the apex Court that compensation scheme has been formulated to ensure proper compensation to the victims of faulty hip implants.
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical device It functions under the Drugs and Cosmetics Act.CDSCO comes under Directorate General of Health Services,Ministry of Health & Family Welfare.
CDSCO is responsible for (a)approval of New Drugs (b)Conduct of Clinical Trials, (c)laying down the standards for Drugs (d)control over the quality of imported Drugs in the country and (e)coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.