Drug regulator. Hero of patient groups or regulator under lens?

It’s an organisation in the eye of many a storm. Intense discussions are triggered when it sets out to cap and control the price of medicines and medical devices.

But, at another level, its own future generates just as intense a discussion.

The National Pharmaceutical Pricing Authority (NPPA) is in a hot seat. Patient groups perceive it as a hero of sorts that keeps a keen watch on drug prices. The view of the industry, though, is quite different, for it bears the brunt of NPPA’s policies.

Barely a week into 2017, discussions are on at the NPPA on a formula to control and cap the price of cardiac stents.

This is the first significant effort to regulate a medical device (besides an earlier fracas on condom prices) and, naturally, the NPPA finds its every move being watched, not just by the pharma and medical devices industries but also by patient advocacy groups. And naturally again, the opinions and counters have begun to dominate public discourse.

“We will take a well reasoned view,” says Bhupendra Singh, NPPA Chairman, when asked about the contours of the stent discussion and the tricky task of freezing a formula to cap device prices. “It is not a decision of the Chairman, but of the Authority,” says Singh in a calm voice, pointing to the involvement of ministries including Health and Finance, besides the Drug Controller General of India.

Sidestepping details on the price control formula, Singh agrees that hospitals and clinics are part of the chain of distribution.

And, though regulating hospitals comes under the Health Ministry and not Department of Pharmaceuticals, he says, hospital and nursing home associations have also been brought to the discussion table.

Every distribution-related margin under the purview of the law and scope of the Drugs (Prices Control) Order (2013) would be exercised, he adds.

Capping the price of medical devices is a recent effort, but not so with medicines.

After several iterations, the National List of Essential Medicines (NLEM-2015) was drawn up and all medicines listed under it were brought under price control. Despite much heat burn, the domestic pharma industry has come to live with the reality of price control, approaching the courts sometimes to seek clarity or redressal on the NPPA’s directives.

But, even as the basic formula of price control on medicines (based on market price and not cost of production) is questioned by public health advocates, a fresh twist has been added to the tale.

Top level meetings attended by the NITI Aayog chief and secretaries from the Pharmaceuticals Department and Department of Industrial Policy and Promotion (DIPP) sought to evaluate delinking price control from the list of essential medicines and the price regulator (NPPA ).

The suggestion was that the NPPA in its present form be “wound up” and “deployed” within the Pharmaceuticals Department with “a new mandate”.

And the right to regulate prices “as per need” would rest with the government, it was indicated, in a clear effort to clip the NPPA’s wings.

The suggestion had patient advocacy groups in a rage — they saw it as a “surgical strike” on medicines.

The coming months will unravel how this discussion pans out. But Singh does not comment on a decision that is finally “the government’s prerogative”.

“The NPPA will carry out its role till it’s there. We have been given a responsibility and we will do it,” insists Singh.

He points out to NPPA’s recent efforts on Wilson’s disease, which did not make for screaming headlines. On receiving information on the shortage of raw material for the drug to treat this disease, the NPPA stepped in and asked three companies to ensure its supply.

Singh is unwilling to slot the NPPA into “water-tight” definitions like “regulator” or “facilitator”, but the price regulator’s role is a constant point of discussion in various quarters.

So, has the NPPA in a sense outlived its use?

“I certainly don’t think so,” says the Chairman emphatically.

COMMENT NOW