Common Mistakes and Troubleshooting

A frequently observed regulatory pitfall is submitting an AYUSH dossier with an incomplete Schedule T GMP compliance record or missing heavy metal and...

A frequently observed regulatory pitfall is submitting an AYUSH dossier with an incomplete Schedule T GMP compliance record or missing heavy metal and microbial testing data, leading to outright rejection; applicants should cross-check every pharmacognostic and quality parameter described in Phase 5 against the specific submission checklist before filing. Adulteration of raw material by an unscrupulous supplier is best detected and prevented through routine in-house DNA barcoding and HPTLC fingerprint testing of every incoming lot, rather than relying solely on supplier certification. Where heavy metal limits are exceeded in a finished product despite compliant raw material testing, processing equipment contamination — particularly from older metal grinding or processing equipment — should be investigated as a likely contributing source alongside the raw material itself.