In recent weeks, India’s pharmaceutical landscape has entered a tense phase. The Drugs Controller General of India (DCGI) has launched a sweeping enforcement campaign targeting small and medium pharma enterprises—particularly those that make cough syrups and other oral liquid medicines. But why this sudden crackdown? And what’s at stake for both public health and the makers of these medicines?.
A Grim Wake-Up Call: Cough Syrup Tragedies Spur Reform
The immediate trigger behind the tighter scrutiny lies in a tragic chain of child fatalities tied to contaminated cough syrups. Brands like Coldrif, Respifresh TR, and ReLife, manufactured by relatively small companies, were flagged by the World Health Organization for containing dangerously high levels of diethylene glycol (DEG)—a toxic industrial solvent.
These were not isolated concerns. Investigations uncovered alarming lapses at manufacturing units—rusty equipment, poor pest control, and the use of non-pharmaceutical grade solvents. Such distressing findings ignited public outrage and a firm message from regulators: safety will no longer be optional.
The Regulator’s Response: No More Grace Periods
To tackle the systemic quality issues, the DCGI has ordered state drug authorities to inspect thousands of MSME (micro, small, and medium enterprise) pharma units for compliance with revised standards under Schedule M, which governs Good Manufacturing Practices (GMP).
A key deadline looms: by 1 January 2026, all manufacturers must comply with these upgraded GMP norms. For those firms that applied for an extension earlier, inspections are now underway to confirm whether real progress has been made. In fact, authorities have warned that non-compliant MSMEs may face closure—a hardline stance meant to force change.
What’s Changed Under the New Rules?
Under the revised Schedule M, drugmakers are now required to bring their operations up to globally recognized benchmarks.
- Implementing a pharma quality system that spans everything from raw materials to final product testing
- Adopting computerized systems for data tracking and batch traceability
- Ensuring vendor qualification—only approved, reliable suppliers can be used
- Upgrading production infrastructure: clean rooms, HVAC (heating, ventilation, air conditioning), microbiology labs, and sterilization protocols
- Testing each batch of raw materials and finished medicine—not just spot checks
Why MSMEs Are Finding It Tough
Despite their importance in India’s pharma ecosystem (MSMEs make up nearly 80% of the country’s ~10,000 pharma units, per DCGI data), these smaller companies are struggling to keep pace. Here’s why:
- High Cost of Upgrades: The infrastructure and system improvements needed to meet global GMPs often require investments that are beyond internal cash reserves.
- Lack of Technical Expertise: Setting up quality management systems, computerized documentation, and traceability in supply chains isn’t just expensive—it demands specialized talent. Many MSMEs don’t have the skilled workforce.
- Funding Challenges: External financing isn’t always available or affordable. Industry bodies warn that many smaller players simply lack access to capital.
- Regulatory Pressure: With no more extensions beyond the end of 2025 for non-compliant MSMEs, the pressure to comply is mounting rapidly.
Bigger Picture: Trust, Reputation, and Global Standards
At its core, this crackdown is as much about restoring trust as it is about enforcing regulations. The deaths following cough syrup consumption exposed not just isolated failures, but potentially systemic vulnerabilities in India’s manufacturing quality checks.
By aligning with WHO-style GMP standards, the DCGI is sending a signal: Indian-made medicines must be safe—not just for export markets, but first and foremost for domestic consumers. Furthermore, improved quality infrastructure could help India maintain and enhance its reputation as a “global pharmacy” capable of producing reliable, world-class medicines.
The Risk of Collateral Damage
That said, the crackdown is not without risks. If many small manufacturers are unable to comply, a wave of shutdowns could lead to drug shortages, especially for generics and low-cost formulations that cater to India’s underserved markets.
Moreover, there’s concern among industry associations that the cost burden is disproportionately heavy on MSMEs, which may not recover these investments easily.
Conclusion: A Necessary Disruption
This regulatory push may feel harsh, especially to smaller pharma companies that operate on thin margins—but it reflects a deeper reckoning. After preventable deaths, India’s drug regulator is drawing a firm line: substandard medicine is unacceptable.
If implemented well, this crackdown could be a turning point—a chance to modernize a fragmented manufacturing sector, build stronger quality systems, and rebuild public confidence in the medicines that millions rely on. But success will depend on how many MSMEs can actually make the leap—and whether the health of the industry, and patients, can weather the short-term pain.
