Clean Tech

Dual charge, double the challenges

PT Jyothi Datta | Updated on July 11, 2021

Shall the twain meet? Pharma profits versus patient interest   -

Will Mansukh Mandaviya’s control over the health and chemicals and fertilizers ministries spell synergy or a conflict of interest?

Just days ahead of the mega Cabinet reshuffle, Mansukh Mandaviya had visited Bharat Biotech, Zydus Cadila, Hester Biosciences and Serum Institute of India. All makers of Covid-19 vaccines, in different stages of deployment in the country.

Mandaviya was then Union Minister of State for Chemicals and Fertilizers (C&F), with the ministry home to the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (NPPA).

So it may not be entirely surprising to see Mandaviya elevated to hold the dual portfolios of Health and C&F, as the country braces for a possible third wave of surge in Covid-19 cases.

The high-profile change, though, was bound to attract discussion, as it involved replacing the two-time Union Health Minister Dr Harsh Vardhan. Some even saw it as a performance review of sorts, given the distressing shortages of medicine and oxygen witnessed during the second wave of the pandemic.

But optics aside, the dual appointment signals a “reverse”, where Health and its regulatory authorities like the Drug Controller General of India (DCGI) now come under a Minister who also oversees the pharmaceutical industry. A tectonic shift that could be read as a “synergy” to help get the job done. Or, could it be in danger of being perceived, especially overseas, as not having enough of an “arm’s-length” separation between regulatory agencies and the healthcare industry (pharmaceuticals, medical devices and hospitals)?

In the past, there have been calls to bring regulatory agencies like the NPPA, which keeps a watch on medicine pricing (and now devices, sanitisers and others too), into the Health Ministry’s fold. But that had not happened, as Health and C&F maintained their respective turfs.

So the reverse sweep to bring Health and C&F under a single Minister is, in a sense, charting an entirely new course. But will it be for the better or worse?

“It can be argued either way,” says former Health Secretary JVR Prasada Rao, adding that it may, in fact, work to advantage in getting the job done. Both ministries have their respective regulatory authorities and will continue to work independently, he observes.

Industry veteran Sudarshan Jain expects the move to bring in an integrated approach. Earlier, it was fragmented, he says, with different authorities coming under different heads. Having a single person heading these two ministries would help take decisions in the interest of the patient, industry and the country, says Jain, who is with the Indian Pharmaceutical Alliance, a platform of large domestic drugmakers.

The industry had interacted with Mandaviya in his previous avatar, during the shortage of the antiviral remdesivir, for example. He was also proactive on shoring up the inventory of amphotericin, the drug used to treat mucormycosis.

Need for safe distance

On the absence of an arm’s-length distance, Jain says any decision taken by the Government is with keeping society and market concerns in mind. So here, too, the Minister would be able to drive sustainable, affordable and quality-driven growth, he says.

Representing the home-gown medical devices industry, Rajiv Nath says the Minister with dual charge will facilitate better coordination between demand and supply. He can help meet the need to keep devices affordable for patients without hampering the margin of producers too much, says Nath, who is with the Association of Indian Medical Device Industry (AiMeD). A balanced decision can be taken by keeping all factors in mind, he adds.

But public health and intellectual property expert KM Gopakumar cautioned that the absence of an arm’s-length separation could be perceived as a conflict of interest — as the DCGI regulates quality, while the Department of Pharmaceuticals’ mandate is to promote industry. There could be a conflict between promoting the ease of doing business and ensuring price control, for instance.

These being the challenges, the new man at the helm of health will need to deftly navigate the waters, which could turn choppy, given the current intense scrutiny on all things health-related.

PT Jyothi Datta

Published on July 11, 2021

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