The Centre has constituted a five-member expert committee to determine the quantum of compensation to be given to patients who have "faulty" hip implants, manufactured by DePuy International, a subsidiary of Johnson and Johnson.
Apart from the five-member expert panel, the Union Health Ministry has asked states and union territories to constitute separate committees so that they can receive such complaints from affected patients.
In a letter, the ministry has asked the states and UTs to bring out advertisements in newspapers so that the affected patients can approach the state-level committee or the state drug controller concerned.
The move comes after a panel, constituted earlier by the Union Health Ministry to investigate complaints about articular surface replacement (ASR) hip implant devices, said in its report that the pharma giant "suppressed" facts on the harm of surgeries afterwards which was conducted on patients in India using "faulty" hip replacement systems.
It had also suggested that the company pay compensation of around Rs 20 lakh to the affected patients. Some of the patients who had suffered due to the faulty implants had questioned the panel's recommendation of the paltry amount, saying it was like "rubbing salt into their wounds".
The Health Ministry, in its order dated August 30, has asked the central expert committee to submit its recommendation to the Central Drugs Standard Control Organisation (CDSCO) within 45 days of receiving recommendations from the state-level panels.
The order said a committee under the Chairmanship of Arun Kumar Aggarwal has given its report which has been accepted by the central government with certain modifications.
"Now the central government has decided to constitute a central expert committee to determine the quantum of compensation, as admissible under the law, in respect of faulty ASR hip implants manufactured by M/s DePuy International Limited, UK and implanted in India," the order said.
The five-member committee will be chaired by R K Arya, director, Sports Injury Centre, Safdurjung Hospital. C S Yadav, department of Orthopaedics, AIIMS in New Delhi; Vineet Sharma, Head of Department of Orthopaedics, King George's Medical University in Lucknow; Bikas Medhi, professor pharmacology, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh; and Bhushan Tilak Kaul, professor of law in Delhi University, will be its members.
"The committee may co-opt any other member and invite other experts to assist it in the examination of the matter," the order said.
According to reports, the expert committee findings say that over 3,600 patients with the faulty implants remain untraceable, and that at least four deaths have been reported from those who underwent surgeries using these devices.
"...action by state governments and UTs is required on the following points - constitution of state level committee...which should comprise two orthopaedic surgeons or physical medical rehabilitation experts from government medical college and hospital, one radiologists from government hospital and a Central Drugs Standard Control Organisation (CDSCO) zonal or sub-zonal office representative and drug controller of respective state as member secretary.
"Advertisements are to be brought out by respective state governments/UTs in newspapers so that affected persons can approach the state level committee or the concerned state drug controller who would be the member secretary of the committee," the letter to states said.
Drugs Controller General of India Eswara Reddy told PTI, "Once the state committees assess the grievance of the patients, they can give their recommendations to the central expert committee which has been formed. Once the five-member central expert committee gives its recommendations, we can take the process of providing compensation forward."
Responding to the development, Vijay Vojhala, who suffered due to faulty implants, said, "The track record of the government on transparency and accountability to patients in the process leading up to this has been abysmal."
"Moving forward from here we need utmost transparency. We also ask (from the government) that there is participation of patients in committees. Else this would lack credibility," Mr Vojhala said.
The Campaign for Affordable and Dignified Affordable Healthcare said, "Coming after unconscionable delay by CDSCO, which has prolonged suffering of patients, we hope the compensation mechanism is enforceable."
The campaign said the regulator should not have allowed a voluntary recall but rather a mandatory recall based on the high failure rate.
"It remains to be seen whether the compensation will be just compensation as recommended by the expert committee as the quantum is likely to fall much short of what Johnson and Johnson compensated patients in the US," the campaign said.