The recent tragedy involving the deaths of children after consuming a contaminated cough syrup has once again laid bare the cracks in India’s drug regulatory system.
It is a grim reminder that lapses in quality control, manufacturing oversight and licensing can have catastrophic consequences. India’s complex drug licensing process often leads to overlaps, inconsistencies, and, at times, regulatory blind spots. Ensuring drug safety, therefore, demands seamless coordination and accountability across both levels of governance.
Let me explain the situation. We carefully count calories, avoid sugar, and track our steps, yet how often do we verify whether the medicines we consume are genuine and safe? This paradox lies at the heart of one of the gravest threats to public health today — counterfeit and substandard medicines.
These falsified drugs not only endanger lives but also erode trust in healthcare systems, compromise treatment outcomes, and impose enormous economic costs. According to the World Health Organization, one in ten medical products in low- and middle-income countries is either substandard or falsified. India, with its vast pharmaceutical industry and 1.4 billion people, is not immune to this menace — and recent incidents serve as a wake-up call for a stronger, unified regulatory mechanism that puts patient safety above all else.
Strengthening the Net: Regulatory and Industry Efforts
The government and the pharmaceutical industry have already taken strong steps to curb the problem. Regulatory oversight has tightened significantly. More frequent inspections, mandatory barcodes and QR codes, and stricter testing protocols have become the norm. Enforcement agencies do conduct interstate raids, dismantling counterfeit networks operating, signalling that counterfeiting is being treated as a serious crime. But the efforts are still not providing enough deterrence to the availability of counterfeit drugs in the market.
The pharmaceutical industry has also invested heavily in securing medicines against counterfeiting. From tamper-proof and traceable packaging to blockchain pilots and mobile-based authentication tools, Indian companies are deploying cutting-edge technology to protect patients. Many firms have strengthened internal quality controls and increased transparency across their supply chains, demonstrating the sector’s commitment to compliance and patient safety.
Yet technology and enforcement can only go so far. The missing piece is public awareness. Counterfeiters thrive on public ignorance and lack of vigilance. Patients rarely verify medicines even when simple tools, such as QR codes, are available. In rural and semi-urban areas, chemists themselves may not always be aware of verification processes. Unlike in food and lifestyle choices, where we are mindful of what we consume, medicines are often taken with blind trust.
Public education as the cornerstone
For India to succeed in this fight, patients and communities must become active partners. Public education is not just desirable, it is indispensable. Healthcare professionals, pharmacists, and companies all have a role to play in guiding people to recognise risks and adopt safe practices.
Building widespread awareness campaigns: With the number of smartphone users in India projected to cross the one-billion mark by 2026, digital channels provide a cost-effective means of spreading awareness swiftly. Social media, mobile applications, and community networks can be harnessed to inform citizens about risks and verification methods.
Discouraging self-medication: Self-medication, especially in rural areas, often drives demand for unregulated and potentially fake medicines. Education must focus on healthcare literacy, responsible use of over-the-counter drugs, and the importance of consulting qualified practitioners
Encouraging everyday vigilance: Patients must develop habits such as checking packaging, scanning QR codes, and purchasing only from licensed pharmacies. This shift in behaviour can only be achieved through sustained awareness campaigns.
Promoting reporting mechanisms: Citizens need to know what steps to take if they suspect a counterfeit, whether reporting to drug authorities, notifying pharmacies, or using government helplines. Education campaigns must highlight both the penalties for offenders and protections for whistleblowers.
Learning from past successes
India has a history of mobilising communities for public health victories. Polio eradication, AIDS control, tobacco awareness campaigns, immunisation under Mission Indradhanush, and the COVID-19 vaccination drive all show how citizen and community participation can change outcomes. The counterfeit medicine crisis now demands a similar nationwide movement driven by informed public action.
The way forward: shared responsibility
The path ahead lies in collective effort. The government must expand digital tracking frameworks and enforce stricter penalties. Drug enforcement agencies should augment their workforce with well-trained and qualified enforcement officials. Industry must continue innovating in packaging, supply-chain security, and consumer-friendly verification tools. Most crucially, the public must treat counterfeit medicines as a direct health threat and remain vigilant.
When enforcement, innovation, and awareness converge, the results will be transformational. India has already laid a strong foundation; the next leap depends on collective responsibility. Incidents like the cough syrup deaths call for urgent action on all the three fronts. By making public education the centrepiece of its strategy, the nation can protect millions of lives and cement its reputation as a global leader in pharmaceutical integrity.
(Former Health Secretary, Government of India; Views expressed are personal)
