90% of country’s cough syrup units inspected; 850 CAPA notices issued in quality crackdown: DCGI

The sector came under intense international scrutiny after Indian-manufactured cough syrups were linked to child deaths in countries including Gambia, Uzbekistan and Cameroon, prompting tighter regulatory oversight and export monitoring.

Raghuvanshi said approximately 850 CAPA notices have been served to firms found manufacturing non-standard quality (NSQ) products.

“Not a single unsatisfactory CAPA has been accepted,” he said, adding that regulators now require data-backed corrective evidence rather than routine assurances such as retraining of operators.

Manufacturers must conduct root cause analyses for failures, whether related to assay (active ingredient measurement), dissolution, instability, sterility, or analytical errors, and submit validated proof of corrective measures before regulatory clearances are restored.

The DCGI made clear that product recalls are compulsory in every instance of quality failure. Enforcement actions range from suspension of product licences to cancellation and closure of facilities until deficiencies are corrected.

“Some of them could be closed down. For some of them, the product licence is cancelled. For some others, suspension will remain till they correct it,” he noted.

Inspections revealed recurring issues including: non-adherence to Good Manufacturing Practices (GMP); inadequate testing of finished formulations; failure to test incoming raw materials; invalid or poorly validated analytical methods; and potency failures in finished products.

In some cases, active ingredient assays showed potency levels significantly below label claims, in extreme instances as low as 40%, raising concerns over degradation, formulation errors, or flawed testing procedures.
Raghuvanshi highlighted the proactive role of state regulators, citing examples such as Himachal Pradesh and Tamil Nadu, where authorities independently conducted audits of cough syrup units.

To enhance transparency, the Central Drugs Standard Control Organisation (CDSCO) has developed a public NSQ dashboard to track compliance history of companies. Procurement agencies will be able to access this data while evaluating tenders, enabling closer scrutiny of firms with repeated violations.

The regulator is also strengthening testing infrastructure, upgrading laboratory capabilities, and enhancing inspector training to ensure sustained improvements.

“We will see where we need to improve, in terms of capacity also, in terms of skills,” Raghuvanshi said.