Headless pharmaceutical bodies spur policy angst

Three key pharmaceuticals-related departments have been without top officials for weeks now. Calls for quick replacements for the retired heads of these departments have met with government indifference, leading to worries of policy paralysis in the pharmaceutical sector.

The Department of Pharmaceuticals, the National Pharmaceutical Pricing Authority (NPPA) — both are under the Ministry of Chemicals and Fertilisers — and the Drug Controller General of India (DCGI), which heads the Central Drug Standard Control Organisation, are currently headless.

Even though their heads retired in the last three months, the government has not announced replacements yet, in spite of calls for firm leadership from the pharmaceutical sector which is reeling from high import costs.

“We need support and direction from the government, but we don’t have a platform now that three pharma departments are virtually headless,” said N R Munjal, immediate past president of the Indian Drug Manufacturers’ Association (Idma).

Munjal recalled that the government was keen to scale up the pharmaceutical sector from the current World No. 3 to No. 1, in terms of value. And in terms of the volume of drugs sold, the government had asked companies to target the No.8 position from No.13 in the next couple of years.

Such ambitious goals are almost impossible to achieve if the plight of the three departments does not improve, he said.
The post of DCGI, which was earlier held by Surinder Singh, fell vacant in October 2011 when the Supreme Court refused to allow the extension of his tenure granted by the Ministry of Health. Since then, there had been no replacement. V G Somani, deputy drugs controller of the East Zone, was given additional responsibility of the DCGI.

Similarly, the Department of Pharmaceuticals, which was created in 2008 to look into the issues of hindrance in growth, infrastructure, research and education in the field of pharmaceuticals, has been operating without a secretary since November 2011, after Mukul Joshi superannuated on October 31. The government got embroiled in internal differences over his replacement, after first asking Loretta Mary Vas to succeed.

In fact, Vas was not allowed to assume responsibility, after chemicals and fertilisers minister M K Alagiri allegedly expressed a preference to have a male secretary in the ministry.

The NPPA, which fixes and revises prices of controlled bulk drugs and formulations, is also suffering from lack of proper leadership. No replacement has been found yet after G Balachandran retired as chairman recently.

“We need policy support from the government, without which the road ahead is ambitious but impossible. The last time we had a major policy change was way back in 1970, when the government mooted the Patent Act,” said Munjal.

Manish Doshi, president of Idma and managing director of Amoli Organics, said it had been a long wait since then for a major policy shift at the international level. “We have been campaigning against bar-coding for exporters, and proposing anti-dumping duties from China on the pharma pricing policy and FDI in the sector.” But nothing has come of it, he added.