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According to sources, Tamil Nadu-based company Srisan Pharma was granted license by the state FDA in 2011 and its manufacturing license was renewed in 2016. However, the state regulator never updated the company’s details in the central drug database, keeping it completely off the radar of CDSCO for almost a decade.
Asked if more such companies were off the CDSCO radar, sources said that often, state FDAs across India do not share details of all drug manufacturers with the CDSCO and said this discrepancy would soon be addressed by the CDSCO.
Sources said to bridge this critical information gap, CDSCO has now launched a nationwide data collection and verification campaign, starting with cough syrup manufacturers, to prepare a comprehensive list of all small, medium and large producers of not only syrups but all drugs and formulations.
Serious systemic lapses exposed
The lapse came to light after three cough syrup brands – Coldrif, Respifresh and Refile – failed safety tests, with Coldrif containing 48.6% DEG, a level that could cause fatal poisoning.
Officials said CDSCO came to know about the existence of Srisan Pharma only when the Tamil Nadu FDA started testing and inspecting the company’s manufacturing site on October 1 and 2. By then, the stock had been seized, and initial reports confirmed the presence of DEG in the formulation.
“This is an alarming failure in coordination between state and central regulators,” a senior official told CNBC-TV18 on condition of anonymity. “CDSCO cannot monitor a company of which it does not even know of existence.”
License granted, renewed, but never reported
Records show that Sreesan Pharma received its initial manufacturing license from the State Drug Authority of Tamil Nadu in 2011, and it was renewed in 2016 without any joint inspection. Under rules introduced in 2017, all new or renewed manufacturing licenses must undergo joint inspection by state FDAs and CDSCO – a process intended to ensure that all registered manufacturers are included within the national system.
However, in this case, the joint inspection never took place and the CDSCO was unaware of the company’s operations, production volumes or product portfolio.
Following this finding, CDSCO has sought a written explanation from Tamil Nadu FDA for failing to update its records and has now ordered all states and union territories to immediately share the updated data of all cough syrup manufacturers under their jurisdiction.
Violations and regulatory consequences
An inspection of Srisan Pharma’s facility by the Tamil Nadu FDA revealed 364 regulatory violations, including 38 significant lapses, ranging from poor documentation and hygiene to non-validated manufacturing practices.
Sources said the violations were so serious that CDSCO recommended immediate cancellation of license and criminal proceedings against the manufacturer. The company’s license has been canceled and the owner arrested, while production has been ordered to be halted.
massive action started
The revelation has triggered a nationwide audit of cough syrup manufacturers, as CDSCO attempts to address systemic deficiencies in drug inspection. The regulator has now launched a All India Joint Inspection Campaign With State FDA to test, inspect and verify all manufacturing units producing cough syrup.
CDSCO has also identified the supplier of DEG used by Srisan Pharma, and is tracing the supply chain to determine whether industrial-grade solvents were used in violation of pharmaceutical standards.
Data Integration and Digital Improvement
Officials acknowledged that the absence of a real-time data-sharing mechanism between state FDAs and the central regulator remains a structural weakness. Although India’s Online Drug Licensing System (ONDLS) has been launched to centralize all manufacturer data, many state regulators are yet to completely migrate their records.
Another senior official said, “This case shows why full OnDLS integration cannot be compromised.” “The fact that a licensed manufacturer was invisible to CDSCO for years.”
The regulator has tightened monitoring
In the wake of the Sreesan case, CDSCO has reiterated the 2023 packaging and labeling norms, which require bold red warnings such as “Not for use in children below 4 years of age” on all cough syrups. The regulator has also initiated risk-based audits using “not of standard quality” (NSQ) data to identify non-compliant units.
The broader objective is to tighten surveillance from raw material sourcing to final product packaging, officials said, to ensure that no unregistered or uninspected facility operates outside the central radar again.