india

Updated: May 01, 2019 08:42 IST

A resident of Uttar Pradesh has been awarded over Rs 1 crore, the highest compensation so far given by the government in the Johnson & Johnson’s (J&J) faulty hip implant case.

Another victim from the state has also been awarded relief, taking the total number of victims being compensated since March this year to four.

The Central Drugs Standard Control Organisation (CDSCO), the regulatory body for Indian pharmaceuticals and medical devices, issued an order on Tuesday, directing J&J to pay Rs1,01,25,993 to one patient and Rs 90,26,567 to another from the same state. The first victim from Maharashtra was awarded Rs 74.5 lakh, while the second one from Delhi had received Rs 65 lakh in April in March this year.

“Four victims have been awarded compensation in the case so far and there are about 200 applications under consideration,” said Dr S Eswara Reddy, drug controller general of India.

While the compensation amount is to be paid within 30 days from the date receipt of the order, J&J has not paid any of the victims so far because they had approached the court in the matter that is yet to be decided.

On November 29, 2018, a central expert committee approved compensation amount between Rs 30 lakh and 1.23 crore, based on a specific formula they created to determine compensation amount for the affected patients. The amount was to be calculated on a case-to-case basis depending on the age and the level of disability of the person, with younger people with higher disability getting the maximum compensation.

All states were asked to form a state-level panel, to track and verify eligible patients, and to come up with an amount on the basis of the central committee’s formula.

The faulty Articular Surface Replacement (ASR) hip implants manufactured by DePuy International Limited, a subsidiary of J&J Pvt Ltd, were recalled in 2010 globally with complaints of more than usual revision surgeries because of complications such as metal leaching, infections among others. The government started awarding compensation amounts from March this year.

“Johnson & Johnson Private Limited remains committed to providing assistance, including appropriate compensation within an established framework, to ASR patients in India who have undergone revision surgery. We believe the formula for compensation needs to be within a fully transparent framework arrived at through due process. We remain committed not only to our patients but also to a positive resolution of the matter. As the matter is sub judice, we are unable to comment further,” said a company spokesperson.

Meanwhile, J&J’s donations to Indian government of bedaquiline that treats multi-drug resistant Tuberculosis (MDR-TB) has drawn flak from activists who say it’s a clear case of conflict of interest. “Ad-hoc donations of bedaquiline threaten sustainable, affordable access for patients; create conflict of interest for health ministry in regulating Johnson & Johnson,” read a letter by activist groups. The letter was written Monday in response to the announcement about a second set of donations of 10,000 courses of bedaquiline by J&J.

The ministry has refuted the allegations. “There’s no conflict of interest as it is not like the government is at the mercy of J&J to donate the drug. This donation was promised earlier under USAID programme. We are also working out arrangements for voluntary licensing through domestic generic manufacturers that is expected to bring down the cost per course which is at $400 currently,” said a senior official.

A J&J India spokesperson, too, dismissed the reports, saying, “Johnson & Johnson did not solicit direct requests from governments as part of the bedaquiline donation program. The Indian government independently approached USAID, which administered the donation program, to request an additional 10,000 courses of bedaquiline...”