In the recent past, the Centre has considered measures to bring about better quality of medical devices. Earlier in this quarter, the National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad signed an MoU with Johnson & Johnson Medical India, to help equip professionals for the segment.

Although the partnership was aimed at revising course content for the institute’s postgraduate programme in medical devices, it could also address a key gap in the field: enabling faculty and students to benefit from industry inputs while staying abreast with changing regulatory norms.

Kiran Kaliya, Director of NIPER, says, “Our collaboration began after they asked us how they could support our programme. So we’re looking forward to their professionals supporting our students.”

Sushobhan Dasgupta, Managing Director of Johnson & Johnson Medical India, adds: “We’re investing time in this initiative. There’s no monetary input by us, and we’re not looking for any commercial benefits from this either.”

Planting seeds

NIPER’s Director expects the institute’s postgraduate talent will pursue PhD programmes, join the industry or land jobs with the government. According to Kaliya, although NIPER has its own highly qualified faculty, she explains that students can be further groomed by internships or practical exposure to the industry, through J&J Medical India.

“We want our students to have exposure to Indian and international norms and regulations. If we train them adequately, when they are employed, they can choose to catalyse the medical devices sector on their own,” she shares.

Johnson & Johnson’s Dasgupta says, “A first batch of students has already been to our Aurangabad facility. In fact, both our Baddi and Aurangabad plants will host the institute’s interns.”

Making change happen

Production of medical devices in India has traditionally been very low compared to the rest of manufacturing taking place in India. Moreover, for the longest time, production has historically been skewed towards less technology intensive categories like disposables. Meanwhile, indigenous productions of medical devices have been widely reported as being of poor quality.

More recently, the Indian government has been not only interested in a number of measures ranging from stricter third party quality assessments to improving talent in the field, but has also come up with draft rules suggesting four categories of medical devices.

Indicating that Johnson and Johnson in India supports these moves with suggestions for classifications, Dasgupta also says the issue of poor quality in indigenous productions isn’t simple.

“The industry has standards, and the government has also been regulating the segment. But currently only about 22 out of the many more categories of medical devices go through checks. Quality control is carried out by State and Central government regulators, but they’re more trained in pharmaceuticals and not specifically in medical devices,” Dasgupta shares.

Notably, the Centre moved a few years ago to separate medical devices regulation from that of legacy rules in the Drugs and Cosmetics Act. And while draft rules under a Medical Devices Bill have been proposed, all stakeholders, whether public or private will have to be involved on ground to create a revolution in the quality of medical devices being made in India.

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