CDSCO tightens quality net with audits and scientific cadre overhaul

Planning to outsource GMP audits to agencies certified by QCI; onboard 1,500 experts to review drug applications

India’s drug regulator is reworking how it polices quality — not just by tightening inspections on the factory floor, but by fixing long-standing capacity gaps inside the regulator itself.

 

Alongside risk-based audits of manufacturing units and an aggressive clean-up of cough syrup facilities that have repeatedly surfaced in quality controversies, the Central Drugs Standard Control Organisation (CDSCO) is moving to plug deep resource and skill gaps by expanding in-house scientific capacity and bringing third-party audit support into the regulatory system.

 

CDSCO to onboard 1,500 experts to create a scientific cadre

 

One of the most significant changes underway is the creation of a permanent scientific cadre within CDSCO — something senior officials say has been missing for decades.

 

Around 1,500 scientists are proposed to be brought into the regulator across areas such as clinical research, biologics, statistics, engineering, and regulatory project management. Nearly 40 per cent of these roles will be flexible or contractual, allowing CDSCO to tap specialist skills as drug technologies evolve.

 

“A regulator without in-house scientific depth is always playing catch-up,” said Rajeev Raghuvanshi, speaking at the 11th Global Pharmaceutical Quality Summit organised by the Indian Pharmaceutical Alliance. While subject expert committees will continue to advise on new drug approvals, officials say internal scientific capacity will reduce dependence on ad-hoc expertise and help shorten approval timelines, especially for complex therapies and clinical trials.

 

Outsourcing audits to plug manpower gaps

 

Alongside this internal build-up, CDSCO is preparing to bring notified third-party agencies into the audit ecosystem to deal with sheer workload pressure.

 

“Until now, audits were conducted only by central and state inspectors. Given our limited manpower, we plan to include notified bodies for assistance,” Raghuvanshi said.

 

These agencies will be certified by the Quality Council of India and may independently carry out GMP and GCP audits for specific product categories. Discussions with QCI on accreditation standards are already underway.

 

Risk-based inspections on the rise

 

On the enforcement side, CDSCO has stepped up risk-based inspections (RBI), where regulatory action is driven by intelligence, past compliance history, and product risk.

 

Since late 2022, CDSCO and state regulators have audited around 1,250 manufacturing sites. Enforcement action — ranging from observations to licence suspension — is linked directly to the severity of non-compliance.

 

“Risk-based inspection is now the backbone of quality oversight. It’s ongoing and it will not be diluted,” Raghuvanshi said.

 

The revised Schedule M, which came fully into force in January 2026, has sharpened this approach. All audits are now benchmarked against upgraded GMP standards, with no extensions left on the table.

 

“If a unit cannot meet revised Schedule M, it should not be manufacturing drugs. There is no justification for allowing sub-standard infrastructure to continue,” he said.

 

Cough syrup units face increased scrutiny

 

Nowhere has this approach been more visible than in cough syrup manufacturing — a segment repeatedly hit by quality failures and international concern.

 

Of around 1,300 cough syrup manufacturers in India, about 1,100 units — over 90 per cent — have been physically audited. Plants with serious deficiencies have faced strong action, including shutdowns where problems were systemic.

 

A string of quality lapses, including a recent contamination-linked incident in Tamil Nadu, accelerated the regulator’s push to clean up the segment.

 

Beyond inspections, CDSCO has introduced digital tracking of high-risk excipients such as propylene glycol and issued detailed public guidance on syrup manufacturing. The regulator expects the impact to become clearer from the next manufacturing season, as weaker players either upgrade or exit.

 

CAPA and NSQ: forcing real correction

 

Another pillar of the new quality framework is the expanded use of Corrective and Preventive Action (CAPA) for Not of Standard Quality (NSQ) drugs.

 

Over the past ten months, CDSCO has issued around 850 CAPA notices, triggered not by inspections but by monthly NSQ surveillance. CAPA is mandatory when failures involve critical parameters such as assay, dissolution, impurities, or sterility. “Until now we have served around 850 CAPA notices to manufacturing firms flagged with NSQ samples,” Raghuvanshi said. None of the CAPA cases, however, has been resolved yet.

 

Once an NSQ is flagged, manufacturers face immediate action, including licence suspension. Licences are restored only after root causes are identified, corrective steps implemented, and effectiveness demonstrated with data.

 

In parallel, NSQ findings trigger mandatory recalls and, depending on severity, can lead to licence cancellation or plant closure.

 

These actions are now backed by a public NSQ dashboard that shows company-wise quality histories. Procurement agencies will also get access, allowing quality track records to influence tender decisions.

 

Quality enforcement is also being pushed down to the states. Under the SPACE framework, state regulators self-assess performance across multiple parameters. States such as Himachal Pradesh and Tamil Nadu have already carried out independent audits of manufacturing clusters.