India’s pharmaceutical market, once known for its affordable and accessible medicines, is now facing an unsettling crisis. The increasing circulation of generic cough syrup brands across the country has sparked nationwide concern. Recent findings of toxic diethylene glycol — a deadly industrial solvent — in several cough syrup samples have raised serious questions about the effectiveness of regulatory oversight and the safety of over-the-counter formulations being sold in local pharmacies.
The Growing Menace of Unregulated Cough Syrups
Over the past few years, the Indian pharmaceutical landscape has become saturated with a flood of generic cough syrup brands. While diversity and competition are generally signs of a healthy market, the problem arises when quality control takes a back seat. Several small-scale manufacturers are reportedly evading regulatory scrutiny, operating outside the formal radar of national and state authorities. These companies exploit loopholes in the drug approval and monitoring process, often at the expense of consumer safety.
Tragic incidents linked to contaminated cough syrups have cast a harsh spotlight on this negligence. The use of diethylene glycol — a chemical typically used in industrial applications like antifreeze — has led to fatal outcomes in some regions. Despite repeated warnings and past episodes, the recurrence of such contamination indicates that systemic issues in manufacturing practices and regulatory supervision persist.
An Overcrowded Market Operating Below the Radar
The Indian cough syrup market is fragmented to the extent that even industry audit firms cannot capture its full scope. According to available data, there are approximately 1,150 registered cough syrup brands being tracked by leading pharma market auditors. However, experts estimate that the actual number could be twice as high, with numerous unregistered and unregulated brands circulating in smaller towns and rural areas.
Smaller pharmaceutical firms aggressively market their products to healthcare professionals by offering incentives — a practice that often outweighs considerations of quality or brand credibility. In smaller cities and towns, chemists themselves play a significant role in influencing sales by recommending brands directly to customers, bypassing doctors altogether. This system, driven largely by profit motives, leaves ample room for low-quality or even hazardous products to enter consumer hands.
Data Gaps and Limited Oversight
While top-tier pharmaceutical companies are closely monitored, smaller firms often remain invisible to regulatory bodies. Sales data for many of these local players are missing from national records, making it nearly impossible to track their distribution networks or quality standards. Many operate outside the ambit of large auditing firms, escaping performance evaluations, safety checks, and compliance requirements.
Despite these data blind spots, market trends show that sales of cough and cold syrups have grown substantially in the last five years. The total value of this category has surged by more than 30%, from approximately ₹2,600 crore to ₹3,400 crore, surpassing the average industry growth rate. This rise reflects both the strong consumer demand for such products and the ease with which new players can enter the market with minimal oversight.
Why Demand Keeps Rising
Several factors contribute to the soaring demand for cough syrups in India. Rapid urbanisation and worsening air pollution have made respiratory infections and dust allergies increasingly common. Seasonal changes and fluctuating temperatures further aggravate these conditions, especially in children and the elderly. As a result, the consumption of cough and cold remedies has become routine in many households.
However, while demand has risen naturally, the quality of available products hasn’t kept pace. The market is flooded with irrational fixed-dose combinations that offer little therapeutic benefit and may even cause harm. Despite a nationwide crackdown and bans on hundreds of such formulations, small manufacturers continue to launch similar products with slight variations to bypass restrictions.
The Role of Regulatory Inefficiency
Weak enforcement by state Food and Drug Administrations (FDAs) has allowed substandard cough syrups to proliferate. Regulatory agencies, often understaffed or lacking modern testing facilities, struggle to inspect the massive number of small-scale production units. In many cases, inspections are irregular or limited to paperwork rather than actual product verification.
In 2023, most of the drugs banned by the central regulator for being “irrational” were combinations intended for cough, cold, and respiratory ailments. These formulations contained multiple active ingredients such as codeine, bromhexine, and dextromethorphan — some of which can interact dangerously or cause dependency when misused. Yet, similar compositions still continue to find their way to shelves under new brand names, indicating how easily the system can be circumvented.
A Market of Contrasts
While the issue of low-quality syrups persists, the legitimate segment of the market continues to thrive. Established pharmaceutical brands maintain a strong presence in the cough syrup category, generating significant sales and setting industry benchmarks. However, a vast number of smaller brands fail to make any measurable impact in sales tracking systems, despite existing in local chemist inventories.
Interestingly, there is also a noticeable regional skew in cough syrup consumption. Northern and eastern states, particularly Bihar and Jharkhand, account for a disproportionately large share of national sales. This suggests that awareness, affordability, and medical supervision vary drastically across regions — making certain areas more vulnerable to the distribution of unregulated products.
The Way Forward: Stronger Regulation and Responsible Manufacturing
The recurring incidents of contamination and irrational formulations underline an urgent need for reform. Regulatory bodies must strengthen their inspection networks, particularly at the state level, and increase coordination with central agencies. Routine product testing, random batch sampling, and stricter penalties for violations can serve as deterrents.
Moreover, awareness among healthcare professionals and consumers is equally vital. Doctors should be encouraged to prescribe only verified, approved brands, while consumers should refrain from self-medicating based on chemist recommendations. Building a transparent digital registry of approved formulations could also enhance accountability and traceability.
Conclusion
The proliferation of unsafe generic cough syrups in India serves as a grim reminder of the gaps that still exist within the country’s pharmaceutical ecosystem. While the market continues to expand, safety and quality must remain non-negotiable. Only through stronger regulation, ethical manufacturing, and responsible marketing can public trust be restored.
DM Pharma Global, a trusted name in the pharmaceutical industry, continues to emphasize the importance of transparency, quality control, and adherence to global manufacturing standards — setting a benchmark for others to follow in ensuring the health and safety of every patient.