India’s apex medical education regulator to ban promotion of medical devices and companies during live surgeries

Live surgeries, while a potential educational tool for surgeons and students, is controversial due to concerns about its effectiveness vis-à-vis pre-recorded videos. (Bloomberg)
Live surgeries, while a potential educational tool for surgeons and students, is controversial due to concerns about its effectiveness vis-à-vis pre-recorded videos. (Bloomberg)
Summary

The government has been turning the screws on pharmaceutical and medical devices companies, which have gone to great lengths to promote their products. The commission will include a provision to prohibit marketing of medical devices and pharmaceutical products and companies during live surgeries.

New Delhi: India plans to ban the promotion and marketing of medical devices and companies during educational live surgeries as part of a broader effort to make regulations for such procedures clearer and more practical, National Medical Commission chairman Dr Abhijat Sheth said in an interview.

According to the current guidelines for livestreaming surgeries, which were framed following a Supreme Court directive, live broadcasts should not be used to promote the operating surgeon, hospital or product brand. Surgeons should not have a financial or commercial interest in the equipment or devices used during the surgery/procedures.

However, some guidelines have created confusion among medical professionals because of certain ambiguities.

“We are working to amend the draft to make it more practical and acceptable to stakeholders," Dr Sheth said. “The previous draft's ‘pan-India procedure’ rule created ambiguity—a procedure considered new in Delhi may not be new in Mumbai or southern India. We are addressing these confusing issues, particularly the definition of ‘new procedures,’ the role of the faculty and the administration."

While the medical education regulator's norms allow live broadcasts for new procedures, it said recordings should be preferred for established procedures or high-risk cases.

The government has been turning the screws on pharmaceutical and medical devices companies, which have gone to great lengths to promote their products. Sheth said the commission will include a provision to prohibit the promotion or marketing of medical devices and pharmaceutical products and companies during live surgeries.

“Our goal is to fix these gaps and make the guidelines clearer and more effective," he said.

Education or entertainment?

Live surgery, while a potential educational tool for surgeons and students, is controversial due to concerns about its effectiveness vis-à-vis pre-recorded videos. The NMC has flagged live broadcasts in private hospitals for exploiting patients for commercial gain, prioritising advertising and self-promotion over patient safety. Due to these concerns, prior permission from regulatory bodies such as the NMC and the State Medical Councils is mandatory for any live surgery.

In 2015, a 62-year-old patient died at the All-India Institute of Medical Sciences in New Delhi during a live laparoscopic liver surgery performed by a visiting Japanese surgeon after excessive bleeding. As a result, the incident sparked ethical and safety debates.

In 2021, a patient died during a live laparoscopic liver surgery at AIIMS, leading the Indian Medical Association (IMA) to call for a ban on these demonstrations due to their entertainment-like nature. However, there is no readily available data on live surgeries conducted in India.

Some experts pointed out the benefits of live surgeries, while acknowledging the concerns associated with live surgeries.

Live surgery allows experts to witness new procedures, along with their practical challenges and solutions, in real time, according to Dr. Rajeev Jayadevan, public health expert and past president of the IMA’s Cochin chapter. He emphasized that the real-time experience brings doctors closer to true competency.

However, Dr Jayadevan added that an invited expert might operate in an unfamiliar environment or without a familiar support team, which could negatively affect the outcome.

“There is also pressure to complete the procedure within a fixed conference slot. Licensing and medical liability add further complexity. While patients worldwide benefit from doctors adopting new techniques, the learning process must be carefully managed to minimize risks to the patient," he said.

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