J&J scandal is India's wake-up call to reform rules for medical devices

The absence of compensation provisions in the Drugs & Cosmetics Act puts the spotlight on the gaps in the regulatory regime

The recent developments in the Johnson and Johnson (J&J) hip implant case have highlighted the gaps in the regulatory regime around medical devices in India. On November 29, the health ministry approved of a formula to determine the compensation to be paid by J&J to the patients who received “faulty articular surface replacement (ASR) hip implants manufactured by DePuy International, UK”. This led to the company approaching the Delhi High Court over the applicability of such an order of the government, in the absence of specific statutory norms to the effect. This has thrown up several legal issues, including the scope of the governing law over medical devices, the Drugs and Cosmetics Act, 1940 (DCA).

Issues concerning medical devices 

• Lack of dedicated law
• Excessive reliance on secondary legislation or rules
• No compensation provisions
• Absence of a sound regulator

Regulating medical devices

At present, medical devices are classified as ‘drugs’ for the purpose of their regulation. “Devices still have to be notified as drugs before they fall within the ambit of the rules (under the DCA). This is because the rules are framed under the DCA, which regulates drugs, necessitating this legal fiction,” said Dhvani Mehta, senior resident fellow at Vidhi Centre for Legal Policy. 

So, whether or not a product is regulated does not depend on its characteristics, as much as it does on whether it has been notified as a drug by the Central Government, she adds.

Concerns with the Act

The law itself is a 1940-legislation with amendments over the years, the most recent being in 2010. The rules underneath the law are updated regularly, with the Medical Devices Rules, 2017, being the latest. This can lead to several concerns, according to experts.
 

“The rules cannot of themselves impose civil or criminal penalties for the manufacture and sale of defective medical devices. These can only be imposed under the DCA,” Mehta said.

Experts noted that keeping up with changes in technological advancements through rules, executive orders, or guidelines was a reactive, haphazard, and incoherent manner of functioning. “If there were a strong primary legal framework, we would not have to resort to regulation in this fashion,” Mehta added.
 

While experts welcomed the Medical Devices Rules, 2017, for setting out a separate regulatory measure, there is still need for an overarching framework specific to the medical devices sector. “Need of the hour is a separate legislation for medical devices that has not seen the light of day so far,” said Milind Antani, lead, pharma and health care practice, Nishith Desai Associates.

Absence of compensation provisions

The recent case filed in by J&J in the Delhi High Court is reflective of the fact that the DCA falls short in providing a mechanism for compensating patients in case of faulty devices. “Provisions relating to compensation to the users of faulty devices have remained unaddressed in the present regulatory regime,” said Rajdutt Shekhar Singh, partner, Singh & Associates.

Mehta called this a weakness in the DCA, given that there is no provision for imposing “civil penalties or awarding compensation for sub-standard drugs or devices". In fact, in a tweet, intellectual property expert Shamnad Basheer called it “sheer naivete” to rely on a report of a toothless government committee. 

Role of the CDSCO

The prime actor in this regulatory regime is the Central Drugs Standard Control Organisation (CDSCO), which works as the Central Licensing Authority. Practitioners maintained that the CDSCO was the authority acting under the DCA and its rules. “As with drugs, the regulation of medical devices is... split between the CDSCO and the state drug licensing authorities,” said Darren Punnen, a member of the pharma and health care practice at Nishith Desai Associates. 
 

However, Mehta pointed out that “there is no explicit mention of the CDSCO in the DCA”. A 2016 public interest litigation filed in the Supreme Court highlighted “the fact that the Ministry of Health and Family Welfare was unable to point to the law or executive order under which the CDSCO was created”. In fact, the 59th Report of the Parliamentary Standing Committee on Health and Family Welfare raised concerns about the CDSCO’s financial and technical capacity, as well as its independence and integrity, Mehta added.

Next steps

A primary legislation specific to the regulation of medical devices is needed, said experts. “An independent legislation governing medical devices would be ideal for both the industry as well as the patients, as the legal requirements could be better tailored to suit the sector, as opposed to being couched within the DCA,” Antani said. That would also assist the regulator to control quality and enforce better, he added. 

Singh noted that “invasive devices (which penetrate inside the body) bearing high risks ought to be brought under the regulatory framework". Post-market surveillance of medical devices would play a significant role in addressing the issue of faulty devices. “Further, the CDSCO is required to evaluate international recalls of medical devices on a real-time basis to avoid such mishaps,” he added.