India Needs an FDA-Style Drug Regulator – Now

It is heartbreaking to learn that 26 children across Madhya Pradesh and Rajasthan recently lost their lives due to cough syrup poisoning. The culprit: Coldrif syrup, manufactured by Sresan Pharmaceuticals, was found to contain 48.6% diethylene glycol (DEG) — a toxic compound nearly 500 times the legal limit. Following the discovery, authorities banned the syrup, froze stock, and seized the remaining bottles. The Central Drugs Standard Control Organization (CDSCO) has initiated inspections, ordered testing of both raw materials and finished products, and demanded explanations for this gross negligence.

Investigations revealed grave lapses at the Sresan Pharmaceuticals factory in Tamil Nadu — from poor hygiene practices and rusting equipment to use of non-pharma grade chemicals and a complete absence of quality assurance. Unfortunately, these regulatory failures are not isolated events — they are symptoms of a systemic problem.

Recurring Tragedies Expose a National Crisis

In 2020, 11 children in Jammu & Kashmir died after consuming substandard cough syrup also sold in Himachal Pradesh, Uttarakhand, Haryana, Uttar Pradesh, Tamil Nadu, Meghalaya, and Tripura. In 2022, more than 70 children in Gambia perished after consuming Indian-made syrups contaminated with DEG. The pattern continued — 18 children in Uzbekistan and another 12 in Jammu & Kashmir between 2019 and 2020 fell victim to similar causes.

More recently, five women died and several suffered kidney failure and organ damage after cesarean operations in Karnataka’s Ballari District Hospital (2024). Tests pointed to endotoxin contamination in Ringer’s Lactate IV solution, signaling yet another case of substandard drug production.

These aren’t coincidences — they reveal a nationwide pattern of failure. The manufacturing unit may be in Tamil Nadu, but victims are spread across India. Because health is a subject on the concurrent list, the prosecuting authority’s power is often limited — especially amid political blame games and jurisdictional confusion.

India’s Regulatory Weakness — A Structural Problem

India’s central regulator, the CDSCO, is heavily understaffed and underpowered. To grasp the scale of the issue, consider this comparison:

• The United States has about 1,580 biopharma facilities and 2,500 drug manufacturers across 48 states, monitored by the FDA with over 18,000 employees — scientists, inspectors, and administrators.
• India has nearly 10,500 manufacturing units and over 3,000 pharma companies — four times more than the U.S. — but employs only about 1,467 drug inspectors (as of 2015) against a need of over 3,000.

In short, India — the so-called “pharmacy of the world” – operates at five times the manufacturing scale of the U.S. but with a fraction of its regulatory strength. The result is an oversight vacuum that endangers public health.

Fragmented Oversight and Weak Enforcement

Drug regulation in India is a tangled web of state licensing authorities (SLAs) and central oversight. States issue manufacturing and sales licenses, conduct inspections, and handle local enforcement, while the Center sets standards and monitors exports. This divided authority breeds inconsistency and confusion.

The result? India’s drug regulatory system remains opaque, under-resourced, and fragmented — a structure that enables negligence to go unchecked.

Expert Voices and Systemic Concerns

Dr. T. Prashant Reddy, co-author of The Truth Pill: The Myth of Drug Regulation in India, has long warned of these failures. He argues that India’s legal and administrative framework allows negligent manufacturers to escape accountability. The Jan Vishwas Act of 2023 made matters worse by decriminalizing several drug-related offenses, even those that directly endanger patient safety.

Dr. Reddy also points to the lack of transparency — with recall notices, violation reports, and inspection findings rarely made public — and blames political interference for further weakening accountability.

What the U.S. FDA Does Right

To understand what India lacks, look at how the U.S. Food and Drug Administration (FDA) operates. In 2019, the FDA discovered trace asbestos contamination in Johnson’s Baby Powder and immediately ordered a recall of 33,000 bottles. The company faced billion-dollar lawsuits and severe financial penalties — not because deaths occurred, but because potential harm was detected.

The FDA routinely conducts surprise inspections, enforces data integrity and record-keeping, and makes all enforcement actions public. It has the power to revoke licenses, order recalls, and take legal action — ensuring that corporations place consumer safety above profit.

In Europe and other developed regions, regulatory agencies maintain similar transparency — publishing inspection reports, warning letters, and recall actions for public scrutiny. This public accountability prevents manufacturers from hiding behind bureaucracy or political influence.

The Road Ahead: India’s Urgent Need for a Strong, Central Regulator

Given the repeated tragedies, expert warnings, and eroding trust in drug safety, India must establish an independent, FDA-style national regulator — one that operates transparently, enforces uniform quality standards, conducts random inspections, and holds violators accountable without political interference.

Only a powerful, autonomous national agency can ensure that every Indian medicine is safe, effective, and produced under strict scrutiny. Until that happens, these preventable deaths will continue — and the phrase “Made in India” in the pharmaceutical world will remain tainted by distrust.