A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New York
A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New YorkREUTERS/Shannon Stapleton

In what could be the biggest compensation in an amount in Indian history, the Union Health Ministry has approved compensation between Rs 30 lakh and Rs 1.23 crore for the patients who received Johnson & Johnson's (J&J's) faulty hip implants before August 2010.

However, the ministry has clarified that the amount of compensation would depend on multiple factors such as age and level of disability. The younger people with a higher degree of disability are likely to get the larger share of the compensation.

Dr S Eswara Reddy, the drug controller general of India, said: "This is the highest ever compensation amount in Indian history. We have been working on it for almost a year to ensure patients get the maximum benefit. And the company has given us in writing that they will pay the entire amount."

The issue is related to the faulty articular surface replacement (ASR) hip implants which were manufactured by DePuy International Limited, a subsidiary of J&J Pvt. Ltd. The product was recalled in 2010 globally after the multiple complaints of follow up surgeries due to complications such as infections and metal leaching.

The issue was triggered after a British study found out that the models had higher failure rates which resulted in the patients forced to opt for a revision surgery. However, J&J stood its ground and claimed that the product was "appropriate" and "responsible", and further the "voluntary recall doesn't imply that the product is faulty".

The manufacturer offered to pay the full compensation to the patients. The health ministry swung into action after it received numerous complaints from the patients and set up an 11 member panel on February 7, 2017, to investigate the matter.

In February, the committee in its recommendations said to have a base compensation of Rs 20 lakh. In response to the committee's report, the central government constituted a central expert committee under the chairmanship of Dr RK Arya, director of the Sports Injury Centre to fairly decide on the quantum of compensation.

Disabilities were chosen under four categories by the committee viz. 20-30, 30-40, 40-50 and 50 above in the percentage terms. Apart from that, the age group was also divided into 10 categories from 20 years and 65 and above.

Committees at the central and state level were formed to examine the affected patients. Center is likely to release the compensation in next 10 days.