For India to be the Setu for Arogaya world, it must unleash bold internal reforms

Cashing in on the sentiment, the government has set in motion—under the Department for Promotion of Industry and Internal Trade (DPIIT)—a fast track mechanism to clear applications of global pharmaceutical companies likely to move out of China and set up base in India.

All this is fine to create excitement around the self-reliance pitch bordering on integration and not isolation. But all such moves can come to naught if India does not mount urgent domestic reforms in the holistic healthcare policy framework.

Any talk of being a leader is fine but the ground situation presents a policy conundrum that is bound to force India to be a laggard in the foreseeable future. It is not lamenting the dismal official healthcare spend as a percent of the GDP; it is far more complex and only a nuanced reading shall mitigate the challenge and potentially help India achieve global scale and speed.

The healthcare management presents today a policy muddle. It lies uncomfortably between various ministries in the Union government. These are the Ministry of Health & Family Welfare, Ministry of Chemicals, Petrochemicals and Fertilizers, Ministry of Science and Bio-Technology, and Ministry of Consumer Affairs. The role of the Commerce ministry is already well articulated.

The Union health ministry is, so to say, the parent ministry and hosts a Union minister and a Minister of State. Given the constitutional mandate, each state government hosts its own health minister. In terms of a regulator, there is the Central Drugs Standard Control Organization (CDSCO), under Directorate General of Health Services, Union Ministry of Health & Family Welfare. Headquartered at New Delhi, CDSCO, has six zonal offices, four sub zonal offices, and thirteen Port offices across the country.

CDSCP is also to ensure the safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

Under the Drugs and Cosmetics Act, CDSCO is also responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organization.

Let us move now to the Ministry of Chemicals, Petrochemicals and Fertilizers, which rightly or wrongly administers independently a key component of the healthcare management in the country. The ministry overviews three departments namely—Department of Chemicals and Petrochemicals, Department of Fertilizers and Department of Pharmaceuticals.

Headed by a Secretary level officer, the Department of Pharmaceuticals (DoP) has been set up with the objective of giving greater focus and thrust on the development of the pharmaceutical sector in the country and to regulate various complex issues related to pricing and availability of medicines at affordable prices, research & development, protection of intellectual property rights and international commitments related to the pharmaceutical sector.

Within its ambit, there is also an independent regulator namely—the National Pharmaceutical Pricing Authority (NPPA). Its key role is to fix and revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.

Under DoP, additionally resides the faculty to build and develop medical devices, a window for pharmaceutical industry promotion, manufacturing of strategic pharmaceutical products under the central public sector enterprises. Jan Aaushdi (a citizen-centric initiative offering affordable medicines) and nurturing quality and excellence in pharmaceutical education and research.

In essence, all of them are key pillars of what is being touted as India’s leverage in building a global healthcare business. But on the ground they reside in non-descript departments oddly tagged inside a ministry which on the face of it has nothing to do with health as a key focus area.

Strangely, this study also throws up the duality of regulators—one in health ministry and the other in the chemicals and fertilizers ministry. This is highly avoidable, especially, since there is another regulator knocking on the doors when it comes to taking an integrated view of the health sector.

The Food Standards Safety Authority of India (FSSAI), popularly known as the food regulator, has some discreet play in the health sector as well. The key remit of the food regulator is to set standards on safe and nutritious food. Most importantly, labeling, a key aspect of the food business, comes under its jurisdiction. Given the play on immunity and nutrition, a key focus of the healthcare business, FSSAI has significant levers under its belt.

Moving away from food, when we talk of the most important piece of drug and vaccine management, there is another ministry that has a role play. The idea is not to grudge them the role but to look at complex duplicity and parallelism often leading to bureaucratic hurdles that have the potential to stymie the India growth story in the sector.

The Department of Bio-technology, led by a Secretary level official, under the administrative control of the Ministry of Science and technology, the mandate is to launch a major, well-directed effort backed by significant investment for the generation of biotech products, processes and technologies to enhance efficiency, productivity. All this makes great sense with COVID-19 a reality that we are destined to live with for some time in the short and medium-term.

With the stated goal of building India as a global healthcare leader, it is imperative that there is a singular cogent policy framework to tap into the huge potential. As has been demonstrated in COVID times, there is a need to diversify the search for resident expertise (textile ministry pushing the medical textiles agenda).

However, it is time to build consensus around creating an umbrella organization. With turfs pretty dear to politicians and their favoured set of bureaucrats, there is a need to set up an urgent empowered Group of Ministers (GoM) tasked with offering the mechanism to set up the new umbrella ministry/body.

There, however, is need to learn from past mistakes. The empowered GoM on pharmaceuticals under Sharad Pawar during the UPA era did not achieve what was expected of it. May be one to be set up under NDA will deliver the magic and actually make India the Setu for an Arogaya world?

-Rakesh Khar is senior editor, Special Projects, Network 18. He writes at the intersection of politics and economy.