Vacant posts cripple drug regulation

Nearly 50% of middle-ranking posts in the Central Drugs Standard Control Organisation (CDSCO) are lying vacant, crippling India’s drug regulatory system.

This comes at a time when foreign regulators are raising red flags about products made by Indian drug companies.

Of the 475 government-sanctioned posts, as many as 236 posts are vacant in the CDSCO. These include 144 posts of drug inspectors and 37 additional drug inspectors, whose task is to check the quality of drugs made by the pharmaceutical companies as well as the quality of medicine stored in medical shops.

In addition, eight posts of deputy drug controller and 15 posts of assistant drug controller are vacant. The newly created post of director (vigilance) is also vacant as the recruitment rules are still to be framed.

Even the post of the Drugs Controller General of India (DCGI) is filled on an additional basis as there is a litigation surrounding the appointment.

As many as 45 posts in the lower hierarchy are “dying cadres”, which CDSCO will phase out eventually. Out of the 45 posts, 29 are vacant.

“Such a high vacancy will seriously undermine the performance and goals of the CDSCO,” a panel of lawmakers informed the health ministry recently. It is already evident as the drug regulator failed to spend almost 59% of its budget in the first 10 months of 2015-16.

If the drug regulating agency wants to spend the balance amount in the remaining two months, it would be a violation of the General Financial Rules of the government that bars spending not more than 33% of the budget in the last quarter and not more than 15% in the last month of a financial year.

The CDSCO’s tardy functioning comes out in the public at a time when the quality of several medicines made in India are being questioned by the Food and Drug Administration of the USA that remains one of the biggest markets for Indian pharmaceutical sector.

Several top companies like Ranbaxy, Sun Pharma, Torrent, Dr Reddy’s Lab, Cadila and Cipla were cautioned by the FDA in the last few years.

Ranbaxy was penalised by the US Department of Justice on felony charges in 2013 and four of Ranbaxy’s manufacturing sites in India — Paonta Sahib, Dewas, Mohali and Toansa — are blocked from dispatching products to the US.

A Parliamentary Standing Committee in 2012 came down heavily on the CDSCO and Health Ministry for having a “collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts” in the Indian drug regulatory system.