CDSCO tightens quality net with audits, scientific cadre overhaul

India's drug regulator sharpens oversight with risk-based inspections, strict Schedule M enforcement and induction of 1,500 scientific professionals to deepen technical capacity and speed reviews

India’s drug regulator is taking multiple steps to tighten the quality assurance framework, combining tougher inspections, data-driven enforcement and structural reform within the regulator itself. While risk-based audits of drug manufacturing units are under way, apart from inspections of cough syrup units that have been in the news for quality mishaps, the Central Drugs Standard Control Organisation (CDSCO) is also creating an internal scientific cadre to speed up the review process in a fast-changing scientific world where new technologies are increasingly shaping drug discovery.

 

One of the most consequential changes under way is the creation of an internal scientific cadre within CDSCO — a gap that regulators acknowledge has constrained institutional memory and technical depth for decades. Around 1,500 scientific professionals are to be inducted, covering clinical science, biologics, statistics, engineering and regulatory project management. About 40 per cent of these positions will be flexible or contractual, allowing the regulator to draw in specialised expertise as technologies evolve.

   

The cadre is expected to play a dual role: strengthening reviews of clinical trials and complex therapies, and supporting high-end inspections, particularly in advanced manufacturing and novel drug platforms. The move is designed to reduce overdependence on external experts while improving review timelines and technical consistency. At present, CDSCO takes the help of subject expert committees (SECs) for reviewing new drug approvals. While SECs will remain, the scientific cadre will strengthen the review process, empowering CDSCO.

 

“A regulator without in-house scientific depth will always be reactive. That is why we are creating a permanent scientific cadre within CDSCO. External experts cannot replace institutional memory. The scientific cadre is meant to ensure continuity, accountability and technical ownership within the regulator,” Rajeev Raghuvanshi, Drugs Controller General of India, said.

 

On the ground, quality enforcement is now anchored in risk-based inspections (RBI) rather than routine, periodic audits. Since end-2022, CDSCO and state regulators have audited around 1,250 manufacturing sites, with regulatory action calibrated to the severity of non-compliance — ranging from minor observations to critical failures.

 

“Risk-based inspection is now the backbone of our quality oversight. It is not a one-time exercise, and it will not be diluted,” Raghuvanshi said, adding that the system has shifted from routine inspections to intelligence-led enforcement.

 

The revised Schedule M, fully enforced from January 2026, has given RBI sharper teeth. All inspections are now conducted against upgraded GMP standards, with no extensions or relaxations remaining. Any unit found non-compliant during an audit faces immediate regulatory action, including suspension or licence cancellation.

 

“Schedule M is not a guideline anymore. It is a statutory requirement, and from January 2026 there will be no extensions or relaxations. If a unit cannot meet the revised Schedule M, it should not be manufacturing drugs. There is no regulatory justification to allow substandard infrastructure to continue,” Raghuvanshi reiterated.

 

Industry insiders feel that this signals a decisive shift from episodic compliance checks to continuous regulatory supervision. Moreover, RBI has evolved into a de facto quality benchmark, increasingly recognised by global buyers and procurement agencies.

 

Cough syrup crackdown: Sector-wide intervention

 

The most visible application of this approach has been in cough syrup manufacturing, following repeated quality failures and international scrutiny.

 

Of the roughly 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 stringent action, including shutdowns where systemic issues could not be corrected.

 

Raghuvanshi did not share the number of units that have been asked to shut down post inspections.

 

A series of quality failures in cough syrup formulations — highlighted by a high-profile incident in Tamil Nadu involving contamination and substandard testing — prompted CDSCO to audit more than 90 per cent of syrup manufacturers and tighten oversight of excipients and production controls.

 

Beyond inspections, CDSCO has introduced digital tracking of high-risk excipients, including propylene glycol, and issued detailed guidance to manufacturers. Regulators say the objective is not cosmetic compliance but a structural clean-up of a segment that had become vulnerable to repeated lapses.

 

Officials expect the impact of this intervention to become visible from the next manufacturing season, as weaker players either upgrade or exit.

 

A key pillar of the new framework is the expanded use of Corrective and Preventive Action (CAPA) for Not of Standard Quality (NSQ) drugs — shifting enforcement from one-off penalties to process correction.

 

Over the past 10 months, CDSCO has issued around 850 CAPA notices, triggered not by audits but by monthly NSQ surveillance data. CAPA is mandatory when NSQs arise from critical parameters such as assay failure, dissolution failure, impurities and sterility issues.

 

Once flagged, manufacturers face immediate administrative action, including licence suspension. Reinstatement is allowed only after the company identifies the root cause, implements corrective changes, and demonstrates effectiveness through validated data.

 

Industry insiders say this approach forces firms to either build real quality systems or leave the market. When an NSQ batch is identified, multiple actions can be triggered depending on severity, including mandatory recall of affected batches, suspension or cancellation of product licences, and plant shutdowns in extreme cases.

 

These actions are now supported by a public NSQ dashboard, which provides a company-wise historical record of quality failures. Procurement agencies will also be given access, allowing tender decisions to factor in a manufacturer’s quality track record.

 

Quality enforcement is no longer confined to the Centre. Under the SPACE framework, state drug regulators are self-scoring their regulatory performance across multiple parameters, ranging from inspection quality to enforcement outcomes.

 

Raghuvanshi said that states such as Himachal Pradesh and Tamil Nadu have already undertaken proactive, independent audits of manufacturing clusters, a shift regulators attribute to tighter coordination and competitive benchmarking.

 

The framework is also intended to prepare India’s regulatory system for deeper global alignment, including World Health Organization listing and eventual convergence with international inspection regimes.