Thiruamuthan, Assistant Editor, India Pharma Outlook
India's pharmaceutical industry, which is frequently hailed as the "pharmacy of the world," serves as a vital contributor in the delivery of reasonably priced medicines across more than 200 nations. Recent occurrences concerning defective cough syrups, however, have shown serious weaknesses in the nation's drug quality system.
Following the tragic deaths of 14 children in the Chhindwara district of Madhya Pradesh, the Punjab government decided to ban the sale and distribution of Coldrif cough syrup. Laboratory tests on batch SR-13 produced by Sresan Pharmaceuticals in Tamil Nadu showed alarmingly high amounts of diethylene glycol (DEG), a dangerous solvent associated with renal failure.
In the wake, the DGHS issued warning recommendations contrary to children's syrups containing DEG, and the Union Health Ministry engaged with state authorities. Few states have imposed temporary bans, and the CDSCO has begun an investigation into this issue. In order to protect public health, this occurrence stresses the immediate need for strong regulatory monitoring, strict quality assurance procedures, and structural changes.
The authorities of India announced in early 2025 that Coldrif Cough Syrup had not met the standards, as it contained diethylene glycol (DEG), a toxic chemical solvent which is highly dangerous; it is used only for antifreeze qualities. The tragedy brought adverse effect on the country’s competency in the medicines manufactured and exported, bringing reminiscing images of similar instances that happened in The Gambia (2022) and Uzbekistan (2023).
According to the officials, laboratory tests resulted in high levels of diethylene glycol in the syrup, which can lead to severe kidney problems, brain damage, and even death, mainly in children. As aforementioned, the incident raised questions about the problems regarding testing, monitoring, and enforcement, once again highlighting the quality issues in the pharmaceutical sector in India.
India's pharmaceutical industry is revered for its capability in offering medicines at real-valuable prices, and it comprises more than 10,000 manufacturing units, from world-class facilities that have been certified by both the U.S. FDA and WHO to small and medium-scale manufacturers with limited resources and inconsistent quality oversight. Despite the fact that this diversity is a major advantage in terms of scale, the quality remains a considerable industry challenge in India.
Fragmented Oversight – In India, the responsibilities for drug regulation are divided between the central and state levels. While the central government, with the Central Drugs Standard Control Organisation (CDSCO), which is responsible for licensing and drugs, designates the state-level regulators to oversee enforcement. The division of authority often leads to poor coordination and inconsistency in quality control among states.
Inadequate Inspections – Reports indicate that many plants can go for years without being inspected. Due to limited resources and heavy caseload, drug inspectors have fewer opportunities to conduct compliance inspections, which is the main cause for less frequent and less thorough inspections. This creates a leeway for substandard or contaminated products to enter the market.
Variable Quality Culture – Some companies have strong Good Manufacturing Practices (GMP), however, a few more companies think compliance is paperwork. Poor recordkeeping, unverified suppliers, and low-quality excipients increase contamination and failure risks for pharmaceutical quality.
The diethylene glycol contamination in drug formulation connects with the use of adulterated glycerin or propylene glycol as solvents in liquid pharmaceutical products, such as cough syrup. Unverified or untested raw material, such as glycerin or propylene glycol as solvents, leads to toxic impurities without unnoticed during the production process.
In the Coldrif case, investigators believe that improper raw material testing and supplier vetting were the key deficiencies. Manufacturers are required to conduct tests on each batch of production for purity, but the need to cut corners, have limited analytical capacity, and sometimes economic pressures lead to bypassing essential protocols.
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India's regulation for the pharmaceutical industry has improved but is still lagging behind when compared with global standards. The Central Drug Standard Control Organization (CDSCO) and various state drug controllers conduct routine sampling for quality and inspections. However, the scale of the operations typically vastly outstrips the available regulatory staff.
Although India is implementing many new GMP standards aligned with WHO guidelines in 2024, there is still inconsistency in implementation. Small manufacturers argue that the implementation of full compliance, including modern testing infrastructure, electronic documentation, and audits with strict compliance, can be prohibitive.
As a result, enforcement is often reactive, triggered only after contamination incidents or export prohibition. Critics claim that until inspections are risk-based and data-driven beyond the US-FDA level, drug manufacturing compliance will continue to be inconsistent in India.
The cough syrup scandals have ignited a long-overdue reckoning within the Indian pharma sector. Industry experts recommend several structural and cultural shifts to bridge the pharmaceutical quality assurance gaps:
Digital Quality Systems: Adoption of electronic batch records, audit trails, and real-time analytics can minimize manual errors and enhance traceability.
Supplier Qualification: Mandatory validation and periodic testing of excipient suppliers can prevent toxic solvent contamination.
Centralized Testing Network: Establishing accredited regional labs under CDSCO could standardize testing and speed up verification processes.
Transparency & Accountability: Public disclosure of quality test failures can create pressure for better compliance and discourage corner-cutting.
Continuous Training: Regular upskilling in GMP, risk management, and toxicology for production staff and quality control teams.
Regulators are starting to tighten the loose ends. Following the Coldrif incident, the Health Ministry proposed risk-based inspection frameworks, mandatory raw materials testing, and improved inter-state coordination. There are also proposals for a National Drug Quality Database to track manufacturing performance, recalls, and test results.
However, experts say policy announcements are not enough. It will need consistent funding, open data, and a change in the organizational culture from viewing compliance as a duty to one of commitment to achieve real change.
The contaminated cough syrup incident had stimulated trust concerns in the Indian pharmaceutical market. As the country remains a global pharmaceutical powerhouse, the incidents reveal that a quality lapse anywhere can lead to a trust deficit everywhere.
Restoring that trust will take time, but with the collective action of regulators, manufacturers, and policymakers. Only then it is possible for the pharmaceutical sector in India to advance its global standards while maintaining unyielding quality integrity.
Why did the Coldrif cough syrup fail quality tests in India?
The Coldrif syrup contained diethylene glycol, a toxic solvent that was identified to be unsafe levels of concentration that likely make the syrup contaminated through raw materials. Investigations suggested the primary breakdown was insufficient checks on suppliers and inadequate batch testing.
How safe are pediatric cough syrups in India after contamination scandals?
Following recent incidents, authorities have increased sampling and testing of pediatric formulations. However, experts warn that sustained vigilance and enforcement are essential to ensure consistent safety.
What regulatory measures does India have to prevent substandard pharmaceuticals?
India’s CDSCO oversees national drug quality, supported by state regulators. New initiatives include revised GMP guidelines, risk-based inspections, and mandatory raw material testing for higher transparency and compliance.
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