The World Health Organization (WHO) has raised fresh concerns over India’s pharmaceutical safety regime, citing persistent gaps in domestic testing and enforcement despite progress in export screening. The statement follows repeated incidents of contaminated cough syrups linked to child deaths abroad. Health authorities in India have pledged stricter oversight, but experts say systemic reform—beyond reactive inspection—is essential for restoring global trust in Indian-made medicines.
Geneva / New Delhi, October 22 —
The World Health Organization has once again urged India to “intensify vigilance and strengthen its pharmaceutical quality controls,” warning that gaps in domestic testing continue to endanger lives despite visible improvements in export surveillance.
The latest statement, issued this week by WHO’s Global Surveillance and Monitoring System for Substandard and Falsified Medicines, comes after India introduced new mandatory testing rules for cough syrups intended for export — a move prompted by international scandals that shook confidence in India’s drug manufacturing sector last year.
“India has made progress in strengthening pre-export testing for certain formulations,” the WHO said. “However, ensuring safety for domestic consumers must be treated with equal urgency.”
The Context: From Pride to Pressure
India, often called the “pharmacy of the developing world,” supplies nearly 20% of global generic medicines and exports pharmaceuticals to over 200 countries. Yet, over the past two years, its reputation has been clouded by contamination tragedies.
In 2022, cough syrups produced by two Indian firms — one based in Haryana, another in Uttar Pradesh — were linked to the deaths of more than 90 children in Gambia and Uzbekistan. Subsequent lab tests by WHO and independent agencies found the medicines contained diethylene glycol (DEG) and ethylene glycol (EG) — toxic chemicals used as industrial solvents.
“Even minute traces of these compounds can be lethal to children,” explained toxicologist Dr. Amrita Varma from AIIMS, Delhi.
The Indian government initially contested WHO’s findings but later tightened export controls through the Drugs (Amendment) Rules, 2023, mandating pre-shipment testing for all cough syrups.
What the WHO Said Now
In its latest review, WHO acknowledged India’s “positive direction” but underscored that domestic testing and regulatory follow-through remain inconsistent.
“There is progress at the border, but vulnerabilities within the domestic market persist. The same standards that protect foreign consumers must apply to Indian citizens,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products.
The agency noted that many state-level drug testing laboratories lack accreditation, adequate staff, and modern equipment. Of India’s 37 state-run labs, fewer than half meet WHO Good Laboratory Practices (GLP) standards.
India’s Response
India’s Ministry of Health and Family Welfare quickly issued a statement defending its regulatory system:
“India has one of the world’s largest pharmaceutical ecosystems. Isolated incidents should not define the whole sector. The government has implemented risk-based inspections, surprise audits, and advanced testing protocols.”
Officials highlighted the role of the Central Drugs Standard Control Organisation (CDSCO), which has expanded its testing network and introduced a national online database for tracking sample results.
However, internal memos reviewed by Sarhind Times reveal that coordination between central and state regulators remains patchy, often resulting in duplication or delay.
Industry Reaction: Defensive but Cooperative
The Indian Drug Manufacturers’ Association (IDMA) and major pharma companies welcomed the call for reform but asked WHO to acknowledge “the positive transformation underway.”
“We are not in denial,” said Suresh Gupta, President of IDMA. “We’ve invested heavily in clean manufacturing lines, automatic testing, and documentation. What we need is unified regulation and faster certification cycles.”
Industry observers note that small and medium enterprises (SMEs), which produce nearly 70% of India’s cough syrups, face the steepest compliance costs.
Lessons from the Tragedies
The Gambian and Uzbek incidents were not isolated. Historical data shows similar outbreaks — including in Chennai (1972) and Bihar (2019) — where contaminated syrups caused mass poisonings.
Each episode triggered short-term crackdowns but limited systemic overhaul. WHO’s new warning underscores that reactive enforcement cannot replace structural reform.
“The pattern is disturbingly cyclical — tragedy, outrage, inspection, and forgetfulness,” said Dr. Vivek Joshi, former CDSCO advisor. “We need preventive vigilance, not post-mortem responses.”
The Inspection Bottleneck
India has roughly 10,500 licensed drug manufacturers, of which only about 3% face annual audits. CDSCO’s manpower is thin — fewer than 3,000 inspectors for the entire country.
State drug departments often suffer from vacant posts, outdated instruments, and political interference. Inspections are frequently “document-based” rather than physical verifications.
A senior official admitted, off record:
“We have the laws, but not the logistics.”
New Rules: What’s Changed
After WHO’s 2023 intervention, India rolled out the Centralised Drug Testing Protocol (CDTP) mandating:
- batch-level testing of all exported syrups for DEG and EG;
- retention of sample archives for at least 3 years;
- QR-based batch traceability for manufacturers;
- random spot testing of domestic consignments.
Early results show improved compliance for export shipments. The challenge lies in extending this rigor to domestic markets, where thousands of small formulations circulate.
How Cough Syrup Turns Deadly
DEG and EG are chemically similar to glycerine — a key ingredient in syrups. When suppliers adulterate or mislabel industrial-grade solvents, toxic contaminants slip through.
“It’s not always malice, sometimes it’s ignorance and poor procurement oversight,” explained Dr. Prakash Dandekar, pharmaceutical chemist.
Once consumed, these chemicals cause acute kidney failure, especially in children, leading to death within days.
Global Ripples
India’s pharmaceutical exports are worth over $25 billion annually, with Africa, Southeast Asia, and Latin America as key destinations. Following the contamination incidents, several importing nations — including Gambia, Ghana, and Indonesia — temporarily suspended purchases from specific Indian firms.
The reputational damage was significant. Even though India quickly revoked licenses of the offending companies, trust erosion continues to affect smaller exporters.
“We never doubted Indian capacity, but we need assurance of safety,” said Abdoulaye Ceesay, Gambia’s Health Ministry spokesperson.
WHO’s Broader Warning
The agency’s global monitoring report identifies five countries — India, China, Indonesia, Nigeria, and Bangladesh — as priority zones for strengthening drug-safety surveillance due to high manufacturing volumes.
WHO is urging member nations to:
- adopt stringent testing for raw ingredients,
- enhance whistle-blower protection for reporting substandard drugs,
- establish regional rapid-response labs for cross-border incidents.
What Experts Recommend
- Unified Regulator: Merge fragmented authorities into a single National Drug Authority.
- Random Market Sampling: Unannounced quality checks in pharmacies.
- Digital Transparency: Publicly accessible batch-level safety dashboards.
- Training for Inspectors: Modern analytical techniques and forensics.
- Zero-Tolerance Penalties: Immediate license cancellation for violations.
“India must transition from reactive governance to anticipatory regulation,” said Prof. Dinesh Thakur, co-author of The Truth Pill, a book on India’s drug regulation crisis.
Balancing Commerce and Compliance
The challenge for India’s pharma industry lies in maintaining competitiveness while meeting rising global safety expectations.
Compliance costs — estimated at ₹500 crore annually for medium-scale producers — could strain small firms, but failure to act could cost far more in reputation and export losses.
“Regulation should not be viewed as punishment,” said Dr. S. Eswara Reddy, former Drugs Controller General of India (DCGI). “It’s the foundation of sustainable trade.”
The Global Trust Equation
Despite recent scrutiny, India remains a major player in affordable medicine. Global health programs, including UNICEFand Global Fund, continue to procure Indian generics. However, agencies now demand extra certification layers and third-party lab testing.
This dual-layer verification, while boosting safety, has lengthened export timelines by up to three weeks for some firms — a logistical cost exporters say they’re willing to bear “if it restores confidence.”
A Matter of National Image
Beyond economics, the issue has become one of soft power. India’s pharmaceutical prowess is a pillar of its foreign-policy narrative. The “Vaccine Maitri” initiative during COVID-19 had elevated India’s image as a global health partner. The syrup controversies, in contrast, dented that halo.
The government now faces the task of demonstrating that “Make in India” also means “Safe in India.”
“Our global credibility depends not just on quantity, but quality,” said Health Minister Mansukh Mandaviya in a recent interview.
Conclusion: A Call for Clean Medicine
The WHO’s message is less condemnation, more caution. India’s pharmaceutical success remains unmatched, but quality assurance must match ambition.
Each bottle of medicine carries not just chemistry, but trust.
If reforms now underway truly reach pharmacies and factories, India can reclaim its moral and medical leadership in the world of affordable healthcare.
Until then, vigilance remains the best prescription.
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