India’s Drug Regulator Flags Major Lapses in Drug Manufacturing After Cough Syrup Deaths
New Delhi, October 9, 2025 — India’s top drug regulator has issued a strong advisory warning pharmaceutical manufacturers over serious violations of drug safety norms after multiple child deaths were reported due to alleged cough syrup contamination.
The Drugs Controller General of India (DCGI), Rajeev Raghuvanshi, said inspections conducted by the Central Drugs Standard Control Organisation (CDSCO) at several factories revealed that companies were skipping critical quality checks — a violation that directly endangers public health.
According to the advisory issued on October 7, several manufacturers were found to be neglecting the mandatory testing of every batch of raw materials and finished medicines — a key requirement under India’s Drugs and Cosmetics Rules.
“It has been observed that manufacturers are not carrying out testing of each batch for verification of compliance with the prescribed standards before using them in manufacture and also in finished products,” the DCGI said in the advisory.
Regulatory Failures and Legal Violations
The DCGI pointed to non-compliance with Rule 74(c) and Rule 78(c)(ii) of the Drugs Rules, which mandate that every batch of both raw materials and final formulations be tested either in-house or at a certified laboratory before use and market release.
The CDSCO has now directed state and union territory drug controllers to intensify inspections of all manufacturing facilities, ensure mandatory batch testing, and verify that raw materials are being procured only from approved and reliable vendors.
This advisory comes amid widespread outrage over the death of at least 20 children in Chhindwara, Madhya Pradesh, who were reportedly given a contaminated cough syrup suspected to contain diethylene glycol (DEG) — a highly toxic industrial solvent.
Chhindwara Tragedy: Lapses Exposed
Investigations have zeroed in on Coldrif, a cough syrup brand produced by Sresan Pharmaceuticals in Tamil Nadu. Initial inspections of the company’s facility revealed alarming lapses — rusted equipment, unhygienic storage, open heating of chemicals, and lack of worker safety protocols.
Samples from the Tamil Nadu unit tested positive for DEG contamination, while those collected in Madhya Pradesh were free from the toxin. The inconsistent results have raised serious questions about the integrity of India’s drug quality control and distribution systems.
A detailed NDTV investigation suggested that both production lapses and distribution failures contributed to the deadly chain of events.
Wider Impact Across States
The Chhindwara incident has triggered nationwide scrutiny of cough syrup manufacturing and sales. In Rajasthan, similar child deaths linked to contaminated syrups have been reported, prompting authorities to suspend specific products from Kayson Pharma.
In Kerala, health authorities have imposed a temporary ban on the sale of cough syrups to children under 12 years without a doctor’s prescription. Meanwhile, the Indian Pharmacists Association has urged chemists across India to stop dispensing cough syrups to infants under two years of age until quality assurance is restored.
The National Human Rights Commission (NHRC) has taken suo motu cognizance of the deaths and issued notices to the governments of Madhya Pradesh, Rajasthan, and Uttar Pradesh, seeking comprehensive reports on the incidents and steps taken to prevent recurrence.
Global Repercussions and Damaged Credibility
India’s reputation as the “pharmacy of the world” has taken a hit following a series of fatal incidents involving contaminated syrups — both domestically and abroad.
In 2022, Indian-manufactured cough syrups were linked to the deaths of dozens of children in The Gambia and Uzbekistan. Those syrups were found contaminated with diethylene glycol (DEG) and ethylene glycol (EG) — the same toxic solvents implicated in the recent Indian tragedy.
In response, India had made pre-export testing of cough syrups mandatory. However, domestic enforcement remains weak, exposing critical gaps in monitoring and accountability.
Experts warn that unless India strengthens internal compliance mechanisms, the country’s pharmaceutical exports and global reputation could face long-term damage.
Centre Orders Risk-Based Inspections
Following the DCGI’s advisory, the Union Health Ministry has directed the CDSCO and state authorities to launch risk-based inspections across pharmaceutical hubs, particularly targeting small and medium-scale units that often escape rigorous oversight.
Several manufacturing facilities have already been ordered to suspend production after being found in violation of safety norms.
Officials said that repeat offenders may face cancellation of licenses, criminal action, and blacklisting from public procurement tenders.
Expert Reactions
Public health experts have welcomed the DCGI’s strict stance but warned that advisories alone are not enough.
“India needs systemic reform in drug regulation. The current model is heavily dependent on self-certification by manufacturers, which is clearly failing,” said a senior pharmacologist associated with the All India Institute of Medical Sciences (AIIMS).
Consumer activists also called for mandatory public disclosure of inspection findings, arguing that transparency is crucial for rebuilding trust in Indian pharmaceuticals.
The Road Ahead for India’s Pharma Oversight
The latest tragedy has reignited debate over the fragmented structure of India’s drug regulatory system, divided between the central government and the states. While CDSCO sets national standards, state drug controllers are primarily responsible for on-ground inspections — a system experts say leads to inconsistent enforcement.
The government is reportedly considering the creation of a National Drug Quality Control Authority to centralize oversight and reduce duplication between agencies.
Meanwhile, the families of the victims in Madhya Pradesh continue to seek justice, as investigations proceed into how contaminated medicine reached state hospitals despite existing bans and testing mandates.
Final Thoughts from TheTrendingPeople.com
The latest advisory from India’s top drug regulator is a stark reminder that quality assurance in pharmaceuticals is not optional — it is a moral and legal obligation. As the world’s largest supplier of generic medicines, India must uphold the highest standards of safety and transparency.
The lives lost in Chhindwara should serve as a turning point for the nation’s drug regulation system. Only through strict enforcement, transparency, and accountability can India reclaim its title as the trusted pharmacy of the world.