India's drug controller vows to fix cough syrup manufacturing 'rot'
What's the story
The Drug Controller General of India (DCGI), Rajeev Singh Raghuvanshi, has announced a major quality control initiative in the past year. The DCGI has inspected over 90% of India's cough syrup manufacturers, visiting around 1,150 facilities. The inspections are part of an intensified oversight program similar to India's risk-based inspection system. Speaking at the sidelines of an industry event in Mumbai, Raghuvanshi declared that regulators expect to "remove the rot of cough‑syrup manufacturing" by the next production season.
Quality improvement
'Remove the rot of cough-syrup manufacturing'
Raghuvanshi said the intensified oversight, which mirrors the rigor of India's risk‑based inspection programme, was aimed at cleaning up a category that has come under global scrutiny. He stressed that these efforts will ensure better quality syrups for domestic consumption and exports. The DCGI hopes these measures will permanently improve manufacturing standards in an industry that has been under scrutiny globally.
Quality assurance
Introduction of Corrective and Preventive Action (CAPA) system
Raghuvanshi also spoke about the Corrective and Preventive Action (CAPA) system introduced in April 2025. This system applies to all Not of Standard Quality (NSQ) drug samples. If a product fails on key parameters like assay or impurity, manufacturers receive a formal CAPA notice, and their manufacturing license is suspended until they submit a satisfactory response.
Compliance challenge
No manufacturer has submitted an acceptable response
Raghuvanshi revealed that around 850 CAPA notices have been issued in the last 10 months, but no manufacturer has submitted an acceptable response. He said, "We initiated the CAPA system... If the products are coming as NSQ because of these four parameters... then we issue a CAPA notice to the manufacturer... and the license is suspended till we get a satisfactory CAPA."