State regulators hold the key to success

As the Centre tries to ensure that high-end stents are available adequately and maintain the sanctity of the price order, state drug regulators have to play a key role in this.

Experts say the efforts of state drug regulators, to a large extent, will determine the extent of success of the government’s move.

Some state government regulators, such as those in Maharashtra and Gujarat, are up in the game. A chief executive officer (CEO) of a leading domestic stent manufacturer told Business Standard that the Nagpur and Pune branches of the Maharashtra Food and Drug Administration (FDA) had recently asked the company to provide it with invoices from February 14.

Industry players said the Gujarat FDA too had asked all companies to provide it with price lists of their products. Incidentally, these two states are headquarters to the highest number of pharmaceutical and health careproviding firms.

However, state drug regulators are short-handed. Karnataka, for instance, is short of 83 drug inspectors, and has 63 now. A senior official in the state told Business Standard the Karnataka FDA had asked the government to recruit officials.

The Drugs and Cosmetics Act empowers state drug regulators to take action against errant players. State drug regulators have the powers to send wrong-doers to jail for three months to seven years and impose penalties on the defaulter in accordance with the Drug Price Control Order (DPCO), 2013.

However, stent manufacturers say keeping an eye only on them and distributors might not help. State drug regulators are missing the pain point for consumers: Hospitals. However, hospitals do not fall under their jurisdiction.

“They cannot ask hospitals to declare invoices or billing receipts of patients. In such cases, who is there to make sure that hospitals do not overcharge?” asks a CEO of a stentmanufacturing company. The state and the Centre, at the moment, are acting on complaints from patients whom hospitals either overcharged or denied high-end stents.

The NPPA (National Pharmaceutical Pricing Authority) order does not differentiate between private and public hospitals or beneficiaries of the Central Government Health Services or state health care. The bottom line of the order is that all patients need to be provided with a stent at the capped price or below.

While some states say they are checking with hospitals if they have stents, other states are acting on complaints instead of checking with hospitals.

Over the past few weeks, the NPPA has been monitoring complaints through an WhatsApp helpline. The regulator has been working with state regulators to investigate complaints of overcharging.

Ever since the NPPA fixed the prices of stents, there have been allegations of artificial shortages created by manufacturers. Responding to this, the NPPA invoked Section 3(i) of the DPCO, 2013, which makes it mandatory for companies to provide the government the details of their weekly plan of production and distribution. Further, this Section mandates companies to not lower production.

Improvement in regulatory infrastructure at the state level will go a long way in making affordable health care more accessible for consumers.