Mandatory Testing of Cough Syrup before Export – Procedure for submission of cough syrups for Testing
Cough syrup exporters will have to undertake testing of their products at specified Government Laboratories and obtain Production of Certificate of Analysis with effect from June 1 before getting permission for the outbound shipments
Ministry of Commerce & Industry has issued a Notification No.06/2023 dated 22nd May 2023 permiting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis (COA) issued by any of the Central Government Laboratories and any NABL Accredited State Drug Testing Laboratory.
The specified Central Government labs include Indian Pharmacopoeia Commission, Regional Drug Testing Lab (RDTL – Chandigarh), Central Drugs Lab (CDL – Kolkata), Central Drug Testing Lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati)] and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of State Governments
In order to facilitate the process of testing of cough syrups at the said laboratories, the following are the pre-requisite requirements for submission of samples :
- Covering letter from the Manufacturer / Exporter on Letterhead addressed to concerned Laboratory
- Manufacturing License of the product for Export purpose
- Export Order
- Representative sample from the export consignment
- Thrice the quantity required for performing complete analysis of the sample
- Qualitative composition of product including excipients
- Certificate of analysis by the manufacturer of the particular batch and method of analysis (STP)
- Reference / Working standard (with traceability certificate) and placebo as applicable