CDSCO launches pan India campaign to test, inspect and audit all cough syrup manufacturers

Following the recent incidents involving poisonous cough syrup, the Central Drugs Standard Control Organization (CDSCO) has launched a nationwide audit and inspection drive to assess compliance, quality and safety standards across all cough syrup manufacturers in the country.

Sources told CNBC-TV18 that the apex drug regulator has directed all states and union territories to submit a detailed list of cough syrup manufacturers under their jurisdiction.

This marks the beginning of a large-scale coordinated national audit of cough syrup facilities, conducted jointly by CDSCO and state drug regulators (FDA).

Priority investigation of past quality defects

Officials said the inspection will be determined by historical data.

Manufacturers who are on the “Not of Standard Quality (NSQ)” list for cough syrup will face priority checks at their facilities. The exercise will involve both domestic manufacturers and exporters and will focus on testing, packaging and raw material sourcing practices.

As part of the action, samples of raw materials such as propylene glycol (PG) and diethylene glycol (DEG) used in the manufacturing of the syrup will also be tested to ensure that they meet pharmaceutical-grade standards. CDSCO has emphasized that the use of industrial-grade solvents in drug manufacturing is a serious violation and will attract immediate punitive action.

Joint CDSCO-State FDA inspection underway

The regulator has ordered joint inspection teams of CDSCO and state FDA officials to conduct physical audit of the manufacturing sites. These teams will verify compliance with Good Manufacturing Practices (GMP) framework, check for lapses in quality control and ensure proper documentation and traceability of all ingredients used in the formulation.

CDSCO has also asked states to confirm whether all cough syrup units are registered on the Online Drug License System (ONDLS), a digital portal launched to bring transparency in India’s drug manufacturing ecosystem.

Packaging, labeling and warning checks a priority

The main focus area of ​​the audit will be packaging and labeling norms. Inspectors will review finished product labels for compliance with dosage warnings, prescription descriptions and child safety advice.

In 2023, CDSCO re-issued strict guidelines stating that all cough syrup bottles must carry a large red warning stating, “Not for use in children below 4 years of age.”

Officials said many small or regional manufacturers were found violating these packaging norms, which could pose potential health risks.

The new inspection campaign will also assess whether warning labels are clearly visible and in compliance with prescribed colour, size and material standards.

Default triggers nationwide action

The intensified regulatory drive follows serious lapses revealed during a recent investigation into Tamil Nadu-based manufacturer Srisan Pharma, whose cough syrup brands were found to be contaminated with high levels of toxic diethylene glycol (DEG).

Sources revealed that Sreesan Pharma was not on CDSCO’s radar as the Tamil Nadu state FDA had never updated its records with the central authority, underscoring major data gaps in India’s drug inspection system. This incident has prompted CDSCO to demand real-time data integration between central and state systems to avoid such blind spots in future.

During a recent inspection, the Tamil Nadu FDA uncovered 364 violations at Srisan’s manufacturing unit, including 38 critical violations. Following these findings, the company’s manufacturing license was canceled and criminal proceedings were initiated.

Read also, Sources say CDSCO and MP state drug regulator have not found any trace of DEG in cough syrup

Nationwide testing, new guidelines ahead

As part of this new enforcement wave, CDSCO is also formulating new guidelines for DEG and EG testing in all cough syrup formulations. While full-batch testing remains logistically challenging for domestic markets, every export batch is already subject to mandatory testing.

Officials said it is aimed at tightening regulatory oversight at every stage from raw material procurement to packaging and restoring confidence in India’s pharmaceutical exports, which have come under scrutiny following repeated global alerts over contaminated syrups.