Pharmaceutical companies in India
Pharmaceutical companies in India

Govt. must address patients' concerns in medical devices regulation

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Malini Aisola, Co-convenor, All India Drug Action Network

NEW DELHI : Hip Implant Patients Support Group (HIPSG) and All India Drug Action Network (AIDAN) have urged the union government to address speedily and urgently their concerns on price controls, approvals and post-marketing regulation of medical devices.

Vijay Vojhala, Joint Convenor and President, HIPSG, said, “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.”

Mr Vojhala, who is also a victim of the Johnson and Johnson faulty hip implant, stated, “Patients and the health of millions in this country must be at the centre of government action.”

Ms Malini Aisola, Co-convenor, All India Drug Action Network, said, “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.”

She said, “As we have pointed out earlier, the collection and response to adverse events in India is equally critical.”

“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,” Ms Aisola added.

We are deeply uncomfortable and principally opposed to consultative processes organised by the government in collaboration and with joint funding from industry, she said.

Instead, we support the Government in holding public consultations which engage all stakeholders on a level platform, a statement said.

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, it said.


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