Never before has the transfer of a drug regulator stirred the pot so much as last week’s transfer of National Pharmaceutical Pricing Authority chairman Bhupendra Singh. He was moved out ahead of time, after a little over two years at the helm and without a replacement being appointed. His predecessor, Injeti Srinivas, was transferred out in less than a year.

The reason why changes at the NPPA have raised uncomfortable questions on possible industry pressure is because the last two chairpersons had taken critical action on drugs and medical devices, bringing them under price control. And while these decisions may have been unpopular with the pharmaceutical and medical device industries, they were intended in the public interest.

There is one thing the NPPA should be credited with. And that is its efforts to bust trade margins by putting out data on the the inflated distribution margins (up to 1000 per cent plus in some cases) on cardiac stents and other consumables.

Transfer buzz

But it’s not just the NPPA that constantly gets the short end of the stick when it comes to appointments. A week before the transfer was announced, news of another bunch of changes was ‘WhatsApped’ across industry circles. There was the appointment, although temporary, of Dr Eswara Reddy as the Drug Controller General of India. He replaced Dr GN Singh who had had a respectable tenure of about six years at the helm.

Then there were a bunch of other transfers in the health ministry, including that of Director General of Health Services Dr Jagdish Prasad, whose exit has come under a cloud.

The DCGI's office deals with giving approvals to drugs and other products marketed in the country. It is tasked with inspecting drug manufacturing facilities across the country, besides watching over clinical trials where medicines are tested on humans and animals. GN Singh’s tenure saw significant action in cleaning up the clinical trials segment and the sale of fixed-dose combination medicines in the country.

Between the DCGI and the NPPA, as drug control and drug pricing regulators, they perform the role of watchdogs over the health of citizens.

You would think they would be given way more importance, especially since politicians use price control on medicines and devices as fodder for their political speeches.

Demotivating actions

Conspiracy theorists may link transfers of key regulators to the industry they may have hurt. And the Health and the Chemicals and Fertiliser ministries under whom the DCGI and NPPA operate, respectively, do not seem inclined to clear the air. But veterans working closely with both Ministries point to the harsh letter announcing the exit of GN Singh and the temporary appointment of Reddy. It provides no motivation to a new comer, says one old-hand on the job.

The office of the NPPA and the DCGI are not about the people seated there, but the task they are expected to undertake. And if the last few incumbents have raised the profile of these offices, it has been done by using the power that the law provides them. As a TN Seshan once did with the Chief Election Commissioner's office.

Making temporary appointments, like with the DCGI, erodes an institution. Or having thinktanks discuss “winding up” the NPPA or tasking it with a regulatory role while housing it in the Department of Pharmaceuticals whose mandate is to promote industry, leaves the NPPA with a complex split personality.

Instead of muzzling the regulators by suggesting that central appointments are done “like this only”, it's time for Government to become proactive, plan ahead of a vacancy and even groom probable candidates with the right scientific and administrative skills for the job, involving a segment of industry.

Both regulators need way more autonomy and teeth and a fixed term of, say, five years to implement policies. And if anyone is removed before their term ends, it needs to be for inefficiency or corruption and that reason needs to be made public. Stability is essential for the industry to be able to work within well-defined parameters.

Shrouding appointments in secrecy and keeping the regulatory framework fluid is not just disconcerting but does little to build the trust that citizens seek in their regulatory institutions.