The $34 billion Indian pharma sector is seeking a unified healthcare regulator that addresses multiple stakeholders’ needs, in an effort to cut through bureaucratic complexities.

Sources at the India Pharma 2019 a two-day FICCI conference told BusinessLine that it is a case of too many cooks, spoiling the broth. “At present we have NITI Aayog, PMJAY, NHA, NPPA, DoP Ministry of Chemicals and Fertilisers, CDSCO, Ministry of Health and Family Welfare and BIS all of which are working in silos,” said an industry representative.

Another pharma-device maker said there are many overlaps (between devices and drugs) and running across to different government departments, which in turn have to get permissions from other departments is time consuming. This delays introduction of new technologies.

Badhri Iyengar, Chairman, FICCI Medical Device Forum said that it is important to have a unified healthcare regulator similar to aviation or insurance which could act as a bridge between the industry and the government to create single window clearance. He suggested CDSCO could lead this initiative.

This way of functioning has had an impact on the healthcare industry, which has seen a change last year with PM Narendra Modi launching Ayushman Bharat. While the government flaunts numbers such as 1 million patient admissions with disbursements of ₹ 1,544 crore in five months, many in the industry believe that lack of understanding of the problems faced by the sector as well as the government’s policies can have an “unintended consequences” on patients. They quote the pricing control on medical equipments such as stents. “While the price controls on stents is good, over a period of time it deters innovation and new stent technologies to come in as the economics may not be viable,” said Shobha Mishra Ghosh, Assistant Secretary General, FICCI.

Badhri Iyengar, who is the Cluster Managing Director, South and East Asia, Smith & Nephew pointed out that the government needs to look at fair profit protection and adopt some flexibility in some of the policies. “The Central Government Health Scheme (CGHS) should revise costs to build in inflation and move away from the government’s “accepted quality” approach to a “good quality” one. Probir Das, Executive Officer- Terumo India, added that technology is dynamic and in the medical devices segment, timeframes have shrunk to six months for product upgrades. “It is different from drugs, which have longer shelf lives. However, it is a vital cog in the healthcare wheel as without devices the healthcare outcomes can take a beating,” said Pavan Choudary, Director General and Chairman, Medical Technology Association of India.

A few days back, the government took a decision to include CT Scan, MRI, dialysis machines and some others as drugs from April next year. This baffled the industry.

Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD) said: “CDSCO consulted and assured the industry of a phased regulatory roadmap, but came out with a notification which is in conflict with what was discussed.”

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