India’s Drug Regulator Is Finally Getting Its Act Together – Here’s Why It Matters
India supplies nearly 20% of the world’s generic medicines. One in every five tablets consumed globally has a good chance of having been made here. That’s a staggering responsibility — and for a long time, the regulatory infrastructure protecting that supply chain was not quite living up to it.
The Central Drugs Standard Control Organisation, or CDSCO, has been undergoing a period of serious reform. If you work in pharma, healthcare, or simply care about medicine quality, this is worth understanding.
How Did We Get Here?
The warning signs had been building for years. The US FDA began issuing import alerts against Indian manufacturing facilities with growing frequency through the 2010s. The European Directorate of Quality in Medicines flagged non-compliance issues. And then came the events that made international headlines.
In 2022 and 2023, contaminated cough syrups manufactured in India were linked to the deaths of dozens of children in Gambia, Uzbekistan, and other countries. The WHO issued global alerts. Governments suspended imports. The reputational damage to Indian pharma was severe — and it forced a genuine reckoning both within the industry and at the regulatory level.
The core problem was structural. CDSCO was significantly understaffed relative to the scale of the industry it was overseeing. It had limited in-house scientific expertise. Inspection systems were inconsistent. And enforcement, when it happened, was often too slow and too light to meaningfully change manufacturer behaviour.
Schedule M: The GMP Overhaul
The most concrete regulatory change in recent years has been the revision of Schedule M — the section of India’s Drugs and Cosmetics Act that lays out Good Manufacturing Practice (GMP) requirements for pharmaceutical companies.
The old Schedule M was widely considered outdated. It didn’t align well with WHO GMP guidelines or with the standards demanded by stringent regulatory authorities in the US, EU, and Japan. The revised Schedule M, which the government formally notified, significantly raises the bar — demanding better facility standards, stricter documentation practices, more rigorous quality management systems, and stronger batch traceability.
Smaller manufacturers were given a phased timeline to comply. Larger ones were expected to move faster. The message was clear: the era of operating comfortably below international standards and selling primarily into the domestic market without scrutiny was ending.
Risk-Based Inspections: A Long-Overdue Shift
One of the more sophisticated changes in CDSCO’s approach is the move toward risk-based inspections. Rather than scheduling inspections on a fixed calendar basis regardless of a facility’s history, the regulator is increasingly directing attention toward higher-risk manufacturers — those with prior non-compliance findings, those making sterile or high-risk products, or those with patterns of quality complaints.
This is standard practice among mature regulators like the US FDA and EMA, and its adoption in India reflects a growing understanding that inspection resources need to be deployed strategically, not spread thin equally across thousands of facilities.
What the Cough Syrup Crisis Changed
The contaminated syrup episodes were a watershed moment. Diethylene glycol and ethylene glycol — industrial solvents — had entered the supply chain as excipients, either through fraudulent suppliers or through failures of incoming material testing. Children died because manufacturers weren’t adequately verifying what they were putting into medicines.
In response, CDSCO significantly intensified scrutiny of the cough syrup manufacturing segment specifically — conducting widespread audits, issuing notices, and in some cases suspending manufacturing licenses. The NSQ (Not of Standard Quality) declaration process was used more actively as an enforcement trigger rather than just a reporting mechanism.
CAPA: Making Corrective Actions Actually Corrective
Any quality management system lives or dies on how seriously it treats Corrective and Preventive Actions — the process by which a manufacturer identifies a quality failure, understands its root cause, and implements changes to prevent recurrence.
Indian pharma’s relationship with CAPA has historically been inconsistent. Filings were sometimes made to satisfy regulators rather than to drive genuine change. CDSCO is increasingly following up on CAPA commitments with re-inspections to verify that changes were actually made — shifting the dynamic from paper compliance to demonstrated improvement.
The Industry Implications
For large, export-oriented Indian pharma companies already operating under US FDA or EU GMP oversight, most of these changes are familiar. The real pressure falls on the vast middle tier of domestic manufacturers who built their businesses under a lighter-touch framework.
Some will invest and adapt. Others will struggle with the capital and organisational demands of genuine GMP compliance. Consolidation in fragmented manufacturing segments is likely over the next several years — which, from a quality standpoint, is not necessarily a bad outcome.
Why This Matters Beyond India
India’s role as the world’s generic pharmacy means that regulatory failures here have consequences far beyond its borders. Low- and middle-income countries that depend on affordable Indian generics have the most at stake. When a contaminated product slips through, it is often the most vulnerable patients — in the poorest countries, with the least healthcare infrastructure — who pay the price.
A stronger, more credible CDSCO is therefore not just good for India’s pharmaceutical export reputation. It is a genuine global public health issue.
The reforms underway are real and meaningful. The test, as always, is in sustained implementation — whether the new standards are applied consistently across large and small players, whether enforcement is insulated from industry pressure, and whether the scientific capacity being built actually gets used.
India has the talent and the industrial base to be a world-class pharmaceutical supplier. The regulatory infrastructure is finally starting to catch up.