Need for Patient-Oriented Comprehensive Regulation of Medical Devices

Statement by Hip Implant Patients Support Group (HIPS) and All India Drug Action Network (AIDAN)

5 October 2019

  1. First and foremost, as civil society, patients and consumers using medical devices we have been alarmed and deeply distressed over the developments of the past month regarding price control measures on medical devices being subject to trade negotiations between the United States and India. Health should never be on the negotiating table in trade agreements especially when it creates impediments in our pathway for self-reliance in health technologies and affordability and accessibility of health services.

We also note with distress the haphazard manner in which consultations on this drastic move by the Indian government took place before the Honourable Prime Minister’s visit to the United States. We are taken aback that civil society and patients did not form any part of the formal consultative process held by the Ministry of Commerce on critical issues that affect our lives and health directly. In this regard we welcome the statement made by the Hon’ble Prime Minister at the United Nations High Level Meeting on Universal Health Coverage that “In our efforts to ensure affordable healthcare, we have slashed the cost of stents by 80% and cut down the cost of knee implants by 50 to 70%.”

We therefore call on the Ministry of Commerce to uphold the Prime Minister’s message and promise to ensure that not even an inch of India’s sovereignty to deal with the prices and affordability of medical devices is on the negotiating table in the ongoing trade talks with the US.

  1. Towards instituting a patient-oriented regulatory regime for medical devices, we believe there is a need to bring in urgent regulations and reforms in the following broad areas:
  • strengthen regulatory systems for ensuring product safety through adequate testing and laying down of norms for clinical trials and related investigations particularly for high-risk devices and implants
  • approval of foreign made devices: examine critically the data submitted by the manufacturers and relied upon by the foreign regulators for approval of devices before deciding to waive trial and testing requirements in India, and in general stop over-reliance on foreign regulatory authorities for granting licenses in India
  • statutory provisions to check unethical business practices in the marketing and promotion of medical devices that cover manufacturers, traders and institutions and greater scrutiny of conflicts of interest of doctors hired by manufacturers to promote or develop devices
  • standard treatment protocols for common procedures involving the use of medical devices and medical audits to curb irrational treatment
  • consistent post-marketing monitoring of performance of devices, particularly high-risk devices, including institution of patient registries
  • urgent need for revamping regulations pertaining to reporting and collection of adverse events and instituting systems to ensure responsiveness of the regulatory agency in dealing with device failures, including public awareness, statutory recalls and cancellation of licenses
  • provisions for compensation to victims of faulty implants
  • affordable pricing – instituting ceiling price caps on devices regulated under the Drugs and Cosmetics Act and commonly used consumables in order to make these critical devices accessible, reduce financial burden of patients to curb corrupt practices that are driving up the costs of healthcare

Each of the above points needs detailed discussion with civil society and patient groups before policy decisions are taken.

  1. In the wake of public health disasters such the Johnson & Johnson ASR metal-on-metal hip implants and global withdrawals due to safety concerns of pacemakers, bioresorbable stents, pelvic mesh, breast implants, etc., there is a growing recognition of the need for strengthening of our medical devices regulatory systems so as to avert risks to patients from faulty and untested devices.

Therefore, we are dismayed at the decision of the CDSCO’s DTAB to further relax the provisions in the Medical Devices Rules, 2017 for granting approvals to imported devices based on marketing approvals by foreign regulatory bodies and extend the waiving of clinical investigations for products approved in the EU through CE certification, in addition to regulatory approvals in US, UK, Australia, Canada or Japan.

CE approval for medical devices, particularly high-risk devices and implants, is a deeply flawed system and must not be used as the basis for allowing inadequately tested devices into the Indian market. Failed devices such as Abbott’s bioresorbable scaffold ABSORB and Johnson & Johnson’s ASR hip implants, among others were approved in India through CE approvals. The International Consortium of Investigative Journalists (ICIJ) has extensively highlighted the flawed system for CE marking approvals of high-risk devices, including weak clinical data requirements, in its recent investigation[1].

We find this development extremely disturbing and cause for grave concern to vulnerable patients in India, that are being exposed to devices that may not have proven safety profiles due to loopholes and corruption in foreign regulations. These devices are being made available solely based on approvals provided by foreign agencies, which neither are accountable to domestic customers, nor can be influenced by our regulatory organizations. The misery of patients is compounded by the fact that laws governing medical devices are toothless, especially when it comes to providing for patient care and support in case of failure of such devices, making reflied available for affected patients and bring erring manufactures to book for transgressions.

A move in this direction, especially at a time when the country is witnessing hundreds of patient’s lives ruined by ASR metal-on-metal hip implants developed by Johnson & Johnson is completely unwarranted and goes against the duty of the government to protect patients.

  1. Finally, we end with a call for better participation and consultation of civil society and patients in the framing and implementation of government laws and policies on medical devices and in the regular work of the medical device committees charged with approvals and monitoring of medical devices.

In Conclusion

We are deeply uncomfortable and principally opposed to consultative processes organised by the government in collaboration and with joint funding from industry. Instead, we support the Government in holding public consultations which engage all stakeholders on a level platform.

There are critical issues before the government, NPPA, CDSCO and medical device committees that require inputs from and proper consultations with civil society and patients. These consultations must take place in an open and transparent manner and through platforms free from even the appearance of industry influence or the appearance of greater weight being given to industry stakeholders and voices.

We once again urge the government to address speedily and urgently our concerns on price controls, approvals and post-marketing regulation of medical devics. In nearly every case of device failures or faults we see an inexcusable time lag between actions taken by foreign regulators and those taken by Indian regulators. This must be remedied as a matter of urgency. As we have pointed out earlier, the collection and response to adverse events in India is equally critical. With the recent developments of price control of medical devices ending up as a negotiating tool for the government and concerns over the framework for approvals and regulations, we regret that rather than patient safety and care, industry safety and care seems to be central to the government’s policies on medical devices. Patients and the health of millions in this country must be at the centre of government action.

For further information, contact:

Vijay Vojhala
Joint Convenor and President
Hip Implant Patients Support Group

Malini Aisola
All India Drug Action Network

Avaneesh Akhoury
Joint Convenor, HIPS

S. Srinivasan
Co-convenor, AIDAN

[1] see and

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