Overview of Pharmaceutical Drug Testing
- Tested by
- NABL-accredited partner lab
- Regulation
- Drugs and Cosmetics Act & IP
- Typical turnaround
- 5–10 working days
- Sample needed
- Per monograph, in original packs
Every medicine made or sold in India must meet its Indian Pharmacopoeia monograph or the standard on its licence. CDSCO and state regulators publish monthly lists of samples found not of standard quality, and the revised Schedule M has raised GMP expectations on testing raw materials and finished products. Manufacturers and loan licensees without full in-house labs use approved external labs for some or all of these tests.
Exporters test to the importing country’s pharmacopoeia, and since 2023 cough syrup exports have needed a certificate of analysis from a government-specified laboratory. Typical tests include identification, assay, related substances, dissolution, uniformity of content, water content, sterility, bacterial endotoxins and microbial limits. Exporters should also hold Pharmexcil registration.
What we do for you
- Lab and parameter list chosen for your purpose: licence, export, buyer or internal QC
- Sampling guidance, and pickup or on-site sampling where needed
- One contact who follows up with the lab until the report is issued
- Report explained in plain language, with next steps if a result fails