Government in a Regulatory Mood!

In a bid to assure Healthcare for All, the government seems to be in an aggressive, regulatory mood.

The Medical Council of India recently reiterated its 2016 notification that doctors prescribe low-cost generic medicines in place of brand names. This was followed by the ministry’s directive to amend the Drugs and Cosmetics Act. The 1-lakh crore pharma industry, reeling under the heightened USFDA scrutiny and recent cashing out by foreign institutional investors of their equity positions resulting in a market cap erosion, is in quite a tizzy with this move. For this to be a success, multiple steps as strengthening the drug approval and drug regulation process, increased inspection of drug facilities, increased awareness of generic drugs and their quality, and rationalizing fixed-dosage combination drugs, needed to be taken before issuing the directive. No doubt, the mandatory bio-equivalence tests to be conducted to ensure generic medicines have the same quality and efficacy as their branded counterparts will help.

This is on the heels of the announcement by National Pharmaceutical Pricing Authority (NPPA) in February 2017, when it capped prices and imposed stringent norms on trade margins and discounts on coronary stents. No doubt it brought the prices down, but it also resulted in Abbott and Medtronic, citing commercial unsustainability, submitting applications seeking to withdraw some of their premium stents, with other multinational companies also contemplating similar moves.

While the move of the government to merge the NPPA and Department of Pharmaceuticals with health ministry is a welcome one, it would be prudent to also bring other departments like Jan Aushadi, Ayush, and Herbals under its ambit, so that a comprehensive healthcare policy can be developed.

In the meantime, the cheese has certainly moved for the savvy, health-conscious citizen, who believes in not proactive but rather reactive medicine. Relying on healthcare trackers, sensors, and wearables that serve with a swarm of useful biometric data to know health parameters, alongwith his GP scrutinizing genetic and past history, is changing the very definition of primary care. Digital health is indeed the new mantra!