CDSCO to get 1,500‑member scientific cadre, will speed up drug approvals

pharmaceuticals

• Government plans CDSCO's first internal scientific cadre of 1,500
• About 40 percent of new hires will be contract experts
• Move to expedite drug approvals and enhance regulatory capacity

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The government has agreed “in principle” to create a 1,500-member scientific cadre at Central Drugs Standard Control Organisation (CDSCO), Drugs Controller General of India (DGCI) Rajeev Singh Raghuvanshi said on February 23, bridging a long‑standing gap that hampered the agency’s efficiency.

CDSCO is finalising the proposal and “will be moving it for approval… maybe latest by next month,” Raghuvanshi said at the sidelines of the 11th Global Pharmaceutical Quality Summit  organised by industry body Indian Pharmaceutical Alliance (IPA) in Mumbai, marking the most significant regulatory staffing reform in decades.

CDSCO has relied too heavily on external subject experts, creating delays and preventing the creation of institutional memory, he said.

“Unless and until the regulator has its own internal scientific cadre, it is very difficult to manage… because of the absence of institutional memory,” he said, adding every clinical‑trial protocol currently depends on outside committees.

The new cadre will bring around 1,500 scientific professionals — from microbiologists to pharmacologists, biostatisticians to engineers and biotechnologists — into CDSCO’s permanent structure.

To ensure flexibility, Raghuvanshi said about 40 percent of the cadre — roughly 600 people — will be appointed on contract, allowing CDSCO to bring in experts from India and abroad as needed for complex therapies and advanced manufacturing reviews.

“This flexible pool can be tapped from anywhere… not only India, not only government,” he said. These recruits would also strengthen inspections, addressing the ongoing shortage of drug inspectors at both state and central levels. “These people will also help in audits… things have become more high‑tech in new therapies,” the DGCI said.

The expanded scientific capacity will directly improve regulatory timelines, which, he said, have been constrained by limited resources.

With the new cadre, India could achieve global‑grade review speeds. “If we get all these resources, the timeline will actually decrease… it can be better than the US FDA,” he said, referring   to America’s Food and Drug Administration.

While he did not specify the rollout date, Raghuvanshi said government systems “take some time”, suggesting implementation may evolve over the next one to two years.