CDSCO Audits Over 90% of Cough Syrup Manufacturers, Aims to Eliminate Quality Issues by Next Season

1,250 Manufacturing Sites Inspected Under Risk Based Framework​

Mumbai, February 23: The Central Drugs Standard Control Organisation has completed audits of more than 90 per cent of cough syrup manufacturers across the country, as part of an intensified quality compliance drive. A senior official said the regulator expects to resolve existing manufacturing concerns by the next production season.

Speaking at the 11th Global Pharmaceutical Quality Summit in Mumbai, Drugs Controller General of India Sanjiv Singh Raghuvanshi confirmed that the inspections covered nearly the entire segment of cough syrup producers operating in India.

1,300 Manufacturers Identified, Majority Audited​

According to Raghuvanshi, there are over 1,300 manufacturers producing cough syrups in the country. Of these, 1,250 sites have already been physically inspected.

“We practically audited more than 90 per cent of cough syrup manufacturers in this country. There are about 1,300 plus manufacturers who were manufacturing cough syrups, and till now we have audited 1,250 of them physically going to their site,” he said.

The inspections were conducted under a risk based inspection model, with serious action taken wherever major non compliances were identified.

Serious Action Taken Against Non Compliant Units​

The regulator said actions were proportionate to the nature and extent of non compliances detected during site visits. Multiple enforcement measures were initiated depending on the severity of violations.

Raghuvanshi stated that the regulator believes the ongoing intervention will address quality issues linked to cough syrup manufacturing before the next season.

“Our belief is that the problem of cough syrup manufacturing will be removed from next season and we will be out of the issues of cough syrup manufacturing,” he said.

Revised Rule M to Strengthen Long Term Quality Standards​

The official also highlighted the implementation of revised Rule M, which has now come into force for all companies after granting applicable extensions.

He said the revised good manufacturing practices framework will have a long term impact on the domestic pharmaceutical industry, particularly in improving the quality of medicines produced in India for both domestic and global markets.

Under the updated compliance norms, manufacturing sites are being audited jointly by state regulators and the central authority, strengthening oversight across jurisdictions.

850 CAPA Notices Issued in 10 Months​

As part of the enforcement drive, authorities have issued around 850 Corrective and Preventive Action notices over the past 10 months to ensure adherence to quality standards and regulatory requirements.

However, Raghuvanshi noted that none of the notices has yet received a satisfactory response.

The ongoing inspection campaign and regulatory tightening signal a focused push by the Central Drugs Standard Control Organisation to strengthen pharmaceutical quality compliance and restore confidence in cough syrup manufacturing standards across the country.