Govt mulls compensation for faulty medical devices post J&J hip implant row

Drugs & Cosmetics Act may be amended; matter to be discussed at drugs advisory board meet

The government is planning to amend the Drugs and Cosmetics Act, 1940, to provide compensation to patients for faulty medical devices sold by a manufacturer or importer.

The matter would be taken up at the next meeting of the Drug Technical Advisory Board (DTAB) later this month, claimed sources. 

This comes in the aftermath of the recent controversy surrounding Johnson & Johnson’s (J&J) ‘faulty’ acetabular surface replacement (ASR) hip implants. 

The hip implants manufactured by J&J’s wholly-owned subsidiary DePuy International were found to be faulty and several instances of further surgeries were reported in India and across the globe. 

There has been a five-year revision for ASR hip-implants globally, which is higher than the expected rate. The artificial hip implants were recalled worldwide by the company in 2010. Around 93,000 patients had received ASR implants globally and nearly 4,700 patients had these implants in India between 2004 and 2010.  

While J&J has agreed to initiate an India-specific reimbursement programme and is cooperating with government agencies in the process of identifying the patients, there was no provision in the existing Drugs and Cosmetics Act to compel J&J to do so. 

The multinational had previously indicated that it is open to paying for further surgeries if needed, diagnostic costs, loss of wages, physiotherapy and other needs of the affected patients. 

In contrast, in the US it had agreed to pay $2.5 billion to around 8,000 patients who had sued the company for the faulty hip implants. 

This was a case when compensation to affected patients depended on whether the device maker or importer voluntarily chose to cooperate. 

“This case brought out the glaring gap in the existing law and the urgent need to plug it. It will be discussed in the next DTAB meeting scheduled for November 29. 

After the DTAB gives nod to the proposal, it would be sent to the ministry of health for its approval,” said a senior official who is directly involved in the process. 

Government sources reveal that by the end of the fiscal, a resolution may be expected on this. 

The domestic medical devices industry welcomed the move. Many felt that an entirely new Medical Devices Act was need of the hour. 

Ganesh P Sabat, chief executive officer of Sahajanand Medical Technologies (SMT), a leading cardiac stent maker in India, said, “We need to have a compensation clause or provision in the Drugs and Cosmetics Act. Makers should be made accountable for faulty devices. We are already late. Since having an entirely new Act may take some time, it’s about time that we make some amendments to the existing one,” he added. 

On the other hand, Rajiv Nath, forum coordinator of Association of Indian Medical Device Industry (AIMED) felt that there is a need to regulate medical devices under a separate Act and making amendments would not go a long way. “We are extremely disappointed that only 23 device categories continue to be regulated under the Drugs Act and have suggested a list of another 38 device categories that need to be under regulations. The real need is for regulating all devices under a separate Act or possibly under an executive order in a phased manner under the Bureau of Indian Standards Act via a quality control order.” 

Legal experts said while the government’s intent is commendable, there are procedural challenges to make such a proposal work. “The compensation clause may be linked to the compensation guidelines (that cover clinical trials). However, there is no specific guideline to do the same for medical devices,” said a legal expert. 

Others felt that product registrations for imported goods need to be made more stringent in order to allow proper regulation. GSK Velu, chairman and managing director, Trivitron Healthcare, one of India's largest medical devices companies, said, “We have to make product registrations more stringent along with factory visits in foreign locations as well as have safety provision, corrective action preventive action and compensation procedures. All these need to be properly addressed through a new medical devices Act along with a department of medical devices.” 

-- Drugs and Cosmetics Act, which is likely to be amended, will have a provision for patient compensation for faulty medical devices

-- The matter is likely to be taken up at the next DTAB meeting

-- The Drugs and Cosmetics Act, 1940, has no specific legal provision to provide compensation to patients
 

--The medical devices industry feels that a new Medical Devices Act is required to regulate the Rs 640-bn market