The Coldrif Tragedy: A Wake Up Call On AYUSH Cross Practice And Pharmaceutical Regulation In India

The Coldrif Tragedy: A Wake-Up Call on AYUSH Cross-Practice and Pharmaceutical Regulation in India

When Children Pay the Price for Systemic Failures

Dr Aakash Kembhavi

The recent Coldrif cough syrup tragedy, where over 21 children died from acute kidney failure after consuming contaminated medication, is not merely a pharmaceutical quality control failure. It is a stark indictment of a deeply flawed healthcare system that has allowed dangerous practices to flourish unchecked for decades. Tests revealed that the syrup contained 48.6% diethylene glycol (DEG), a toxic industrial solvent—nearly 480 times the permissible limit of 0.1%—causing fatal renal failure in children.

This is not an isolated incident. In 2022, 70 children died in The Gambia after consuming contaminated cough syrups manufactured by Maiden Pharmaceuticals in India. The WHO recorded 300 child fatalities in 2022 across seven countries due to contaminated medication from various manufacturers. The pattern is clear and damning: India’s pharmaceutical oversight system is failing catastrophically, and our children are dying as a result.

The Elephant in the Room: AYUSH Cross-Practice

While investigations into manufacturing violations are essential, we must confront a larger, more uncomfortable truth: the widespread practice of allopathic medicine by AYUSH doctors who lack proper training in this system.

Currently, over 770,000 registered AYUSH doctors practice in India, with Ayurveda graduates comprising 428,884 (approximately 55.4%) of this number. Even if we conservatively estimate that 30% practice their designated system, this means approximately 539,000 AYUSH doctors are practicing allopathy or mixopathy across India—a number larger than many state populations.

Directors of Ayurveda departments in Maharashtra and Chattisgarh have acknowledged that BAMS students and graduates work as understudies in allopathic practitioners’ clinics to learn about antibiotics, painkillers, and other modern medications, later starting independent allopathic practice or joining smaller hospitals on cheaper salaries. Private BAMS graduates are in high demand in urban areas where nursing homes and even 100-bed hospitals employ them to function as second-line workforce, managing post-operative and ICU work.

Who Prescribes What?

When a child presents with a cough and fever, who is more likely to prescribe appropriately according to evidence-based guidelines—an MBBS doctor trained in allopathic pharmacology, or a BAMS graduate who learned antibiotics through informal apprenticeship?

The FDA and major pediatric bodies recommend against using OTC cough and cold medicines in children under 2-4 years of age due to potential life-threatening side effects. Yet cough syrups—both allopathic and Ayurvedic—are being prescribed indiscriminately across India.

The Coldrif tragedy involved an allopathic formulation. MBBS doctors, trained in modern medicine, are expected to prescribe medications manufactured and marketed by pharmaceutical companies—this is their professional domain and responsibility for which they have undergone rigorous training. But here’s the critical question: Why are AYUSH doctors, untrained in allopathic pharmacology, adding to this prescribing burden without undergoing the requisite education and training?

When AYUSH practitioners engage in cross-practice, prescribing allopathic medications including antibiotics and cough syrups to children, they do so without formal training in:

  • Evidence-based allopathic pharmacology
  • Understanding contraindications and drug interactions
  • Appropriate age-based dosing and restrictions
  • Recognition of adverse drug reactions
  • Clinical decision-making protocols for modern medicine

They are adding to the disease burden rather than alleviating it. We don’t know how many inappropriate prescriptions are written by untrained cross-practitioners because the system doesn’t track this information. What we do know is that this unregulated practice contributes to irrational drug use, antimicrobial resistance, and potentially, preventable adverse events—all while diluting accountability in an already overburdened healthcare system.

The “Herbal Means Safe” Delusion

India has over 8,000 registered companies manufacturing Ayurvedic medicines according to AYUSH Ministry statistics, with thousands producing cough syrups using herbs and other ingredients. There is a dangerous, widespread myth that “herbal equals safe.”

While a pharmacovigilance program exists for AYUSH drugs, the common misconception is that herbal medicines are completely safe and can be consumed without a physician’s prescription. In the first six months of 2025, only 382 suspected Adverse Drug Reactions were reported for AYUSH drugs nationally—a number so low it suggests massive underreporting rather than actual safety.

Are Ayurvedic Pharmaceutical Companies Adequately Regulated?

The answer is troubling. While a three-tier pharmacovigilance network exists on paper with a National Pharmacovigilance Centre, Intermediary Centres, and Peripheral Centres, the infrastructure remains weak. Lack of knowledge about the concept and importance of pharmacovigilance among AYUSH practitioners compounds the matter.

Critical questions remain unanswered:

  • Are all 8,000+ Ayurvedic pharmaceutical companies regularly inspected for Good Manufacturing Practices?
  • Is raw material testing mandatory and enforced?
  • How many Ayurvedic cough syrups undergo rigorous quality control checks for contamination?
  • What percentage of AYUSH practitioners even know how to report an adverse drug reaction?

The toxic contamination in Coldrif occurred because manufacturers substituted pharmaceutical-grade propylene glycol with cheaper industrial DEG to maximize profits. The detection of 48.6% DEG suggests deliberate substitution rather than accidental contamination, enabled by weak accountability enforcement that prioritizes license cancellations over criminal prosecution. Could similar cost-cutting occur in Ayurvedic pharmaceutical manufacturing? Without robust oversight, we cannot rule it out.

Who Bears Responsibility for Cross-Practice?

This brings us to the fundamental question: Who is accountable when AYUSH doctors practice allopathy without proper training?

The Legal Position

The Supreme Court and National Consumer Disputes Redressal Commission have ruled clearly: AYUSH practitioners cannot prescribe allopathic medicines unless they are also enrolled in a State Medical Register under the Indian Medical Council Act, 1956. Several states including Madhya Pradesh, Uttar Pradesh, Maharashtra, Karnataka, and Punjab have issued circulars allowing Ayurveda practitioners to use allopathic medicines, especially in medical emergencies.

This creates a confusing patchwork of regulations where AYUSH cross-practice is legal in some states but illegal in others. A patient in Kerala cannot receive allopathic treatment from a BAMS doctor, but the same doctor can prescribe freely just across the border in Karnataka.

The Reality on the Ground

The BAMS curriculum is virtually a clone of the MBBS program and follows the same pattern of subject classification and content, but undergraduates receive instruction in biomedical subjects from AYUSH faculty members rather than allopathic specialists, with very little practical exposure because in-patient admission in AYUSH hospitals is very small.

The bitter truth: BAMS has become a backdoor license to practice allopathy. Students enter these programs knowing they will likely practice modern medicine, yet receive inadequate training in pharmacology, evidence-based medicine, and clinical decision-making that are central to allopathic practice.

The Antibiotic Resistance Crisis

India is already a significant contributor to global antibiotic resistance. The WHO has laid down specific rules for antibiotic and cough syrup prescription in children and adults. When 539,000+ AYUSH practitioners prescribe antibiotics without formal training in:

  • Appropriate antibiotic selection
  • Correct dosing based on pharmacokinetics
  • Understanding drug resistance patterns
  • Recognizing contraindications and drug interactions

…we are accelerating the antimicrobial resistance crisis while simultaneously compromising patient safety.

The Ayurveda curriculum largely ignores the limitations of the system, such as management of acute life-threatening emergencies and infective conditions, and gives little practical exposure to prevention and management of lifestyle diseases or chronic conditions. How then can we expect appropriate antibiotic stewardship from practitioners not trained in these principles?

Systemic Accountability: A Void of Responsibility

The tragedy exposes multiple accountability failures:

The AYUSH Ministry

Has the Ministry adequately:

  • Enforced quality standards in 8,000+ pharmaceutical companies?
  • Ensured robust pharmacovigilance systems are functional?
  • Addressed the elephant in the room—that most AYUSH graduates practice allopathy?
  • Created clear regulations on cross-practice with appropriate training requirements?

State Governments

State-level regulations on AYUSH cross-practice are inconsistent and often motivated by political considerations rather than patient safety. States that allow cross-practice rarely mandate adequate bridge courses or supervision.

The Central Drugs Standard Control Organisation (CDSCO)

The CDSCO ordered strict compliance with revised Schedule M norms and updated GMP standards, mandating Quality Risk Management, supply chain traceability, DEG/EG testing, data integrity, and pharmacovigilance systems by December 31, 2025. But enforcement of existing regulations has been chronically weak. Will these new measures be different?

Medical Education Regulators

Both the National Medical Commission and AYUSH regulatory bodies have failed to address the fundamental disconnect: AYUSH doctors are being trained in one system but practicing another, with predictably dangerous outcomes.

The Medical Community

The Indian Medical Association has opposed AYUSH cross-practice, calling it a social evil and malpractice, and advising members not to employ AYUSH doctors as assistants. However, economic realities drive many private hospitals and nursing homes to hire BAMS doctors for their lower salary requirements, perpetuating the problem.

What Needs to Change?

Immediate Actions

  • Mandatory Quality Testing: Every batch of pediatric formulations—allopathic and Ayurvedic—should undergo mandatory DEG/EG testing before market release.
  • Strengthen Pharmacovigilance: Make ADR reporting mandatory for all practitioners with penalties for non-compliance. Currently, reporting is voluntary and grossly underutilized.
  • Standardize Cross-Practice Regulations: Create uniform national standards for AYUSH practitioners who wish to prescribe allopathic medicines, including:Mandatory comprehensive bridge courses (minimum 1-2 years, not 6 months)
  • Clinical rotations in allopathic hospitals
  • Examinations in pharmacology, clinical medicine, and emergency care

  • Licensing separate from AYUSH registration

  • Enhanced Pharmaceutical Oversight: Unannounced inspections, mandatory batch testing, and severe penalties including imprisonment for deliberate contamination.

Long-term Reforms

  • Honest Curriculum Reform: Either train AYUSH students properly in allopathy if they will practice it, or create clear boundaries preventing cross-practice. The current hybrid model serves neither system well.
  • Robust Enforcement: Laws exist on paper. Consumer courts have ruled that AYUSH practitioners prescribing allopathic medicines commit deficiency of service. These rulings must translate into systematic accountability.
  • Address the Doctor Shortage Properly: India faces an acute shortage of allopathic doctors. The solution is not to paper over this gap with inadequately trained practitioners, but to:Increase MBBS seats in government medical colleges
  • Improve working conditions in rural areas
  • Create well-designed physician assistant programs with proper training

  • Strengthen AYUSH practice in its own right, with clear scope of practice

  • Cultural Change in Safety Reporting: Create a culture where reporting adverse events is encouraged rather than feared, and where patient safety trumps professional ego.

Conclusion: How Many More Children Must Die?

The Coldrif tragedy, the Gambia deaths, and countless unreported adverse events are not inevitable accidents. They are the predictable consequences of systemic failures we have chosen to ignore.

We have created a bizarre situation where:

  • Over half a million practitioners prescribe medicines from a system they weren’t trained in
  • Pharmaceutical companies operate with inadequate oversight
  • Regulatory bodies issue conflicting guidelines
  • Accountability is diffused to the point of non-existence
  • And children die

The question is not whether this will happen again—it will. The question is: How many more children must die before we acknowledge and address these fundamental systemic problems?

BAMS education cannot continue to function as a convenient backdoor to allopathic practice. We cannot continue to pretend that “herbal” automatically means “safe” when pharmaceutical manufacturing controls are inadequate. We cannot maintain the fiction that 8,000+ companies can be adequately regulated with our current infrastructure.

The Coldrif tragedy demands more than prosecuting one pharmaceutical company. It demands we finally confront uncomfortable truths about how medicine is practiced, regulated, and enforced in India. Until we do, we will continue to write articles about preventable deaths, offer condolences to grieving families, and wait for the next tragedy that everyone saw coming but no one prevented.

The children of India deserve better. They deserve a healthcare system where practice boundaries are clear and enforced, where pharmaceutical safety is non-negotiable, and where those who prescribe medicines are actually trained to do so safely.

Anything less is not just a regulatory failure—it is a moral catastrophe.

Note: This article is based on publicly available information about the Coldrif tragedy, the Gambia cough syrup deaths, and research on AYUSH medical practice in India. All statistics and quotes are sourced from government data, peer-reviewed medical literature, and credible news reports.

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