Challenges galore as new DCGI takes charge

Raghuvanshi had worked for long durations at pharma majors Ranbaxy and Dr Reddy’s before joining the Indian Pharmacopoeia Commission. (Image credit: News18.com)

Rajeev Singh Raghuvanshi, on February 23, took charge as the new Drug Controller General of India (DCGI) and will now head the Central Drugs Standard Control Organisation (CDSCO), a government body that regulates drug manufacturing, their sale and distribution across the country.

This is for the first time that a person with a strong background in the corporate sector has been appointed as the DCGI.

Raghuvanshi had worked for long durations at pharma majors Ranbaxy Laboratories and Dr Reddy’s Laboratories before joining the Indian Pharmacopoeia Commission, a government agency, where he was serving as secretary-cum-scientific advisor ahead of the latest appointment.

All the former chief drug regulators, on the other hand, have been associated only with government agencies prior to their appointment at the crucial post.

Raghuvanshi will work as the DCGI for the next three years, said the letter issued by the Appointments Committee of the Cabinet under the department of personnel and training on February 22.

He takes over from the former full-time DCGI V G Somani whose term had expired last August but was being given several short extensions over the last few months.

Not a rosy path ahead

Raghuvanshi’s appointment comes at a time when some India-made drugs such as cough syrups and eye drops have triggered a global controversy following allegations of serious adverse events, including deaths, in various countries.

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“Quality control and quality assurance of the drugs manufactured in India are two key issues that are at stake from the perspective of drug regulation and may be major challenges for the new DCGI,” said a CDSCO insider.

Another official in the organisation pointed out that while Raghuvanshi may be familiar with the pharma industry, courtesy his role at the IPC, it may be quite a task to manoeuvre the medical device industry that is now growing rapidly in India.

Little background, big task

While sources in IPC vouched for Raghuvanshi’s deep interest in technology and science, the fact that he does not have a strong background in drug regulation may be quite a disadvantage, they said.

A senior executive associated with a pharma company in Hyderabad also agreed.

“The new DCGI may take months to even get a hands-on idea of how the processes work in CDSCO since he does not have any experience of the same at either the central or state levels,” he said.

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Most of the DCGIs, thus far, had been elevated from senior positions at the CDSCO and also had long exposures at the state Food and Drug Administrations.