147 Receipt of Cough Syrup of same batch No.by two different NABL Accredited Government Laboratories Manufactured by the same Manufacturers/Exporters 2023-Jul-28 394 KB

File No: DCGI/MISC/2023/09 Government of India Directorate General of Health Services Central Drugs Standard Control Organization FDA Bhawan, Kotla Road, New Delhi-110002

Date: 28" July, 2023

To,

All Drug Manufacturers Associations/Exporters

Subject: - Receipt of Cough Syrup of same batch number by two different NABL Accredited Government Laboratories, Manufactured by same Manufacturers/Exporters-reg.

Ref: F.No. DCGI/MISC/2023/09 dated 03" July, 2023

Sir,

Further to this Directorates letter vide File No. DCGI/MISC/2023/09 dated 03.07.2023, it is noticed that cough syrup samples of same batch number, manufactured by the same manufacturer (for export purpose) is being received by two different laboratories for testing purposes which is highly objectionable and not acceptable.

In view of above, it is hereby directed that no manufacturer/ exporter shall submit the same batch nos. of cough syrup manufactured by them to two or more laboratories. If such cases are reported further, the samples of those manufacturer/exporters shall not be accepted for testing by any of the NABL accredited Government laboratories.

The above is issued for strict compliance.

Yours faithfully, Drugs(Dr. RajeController | Generalwoh(India) Central Licensing Authority

Copy to:

1. 1.Website of CDSCO

2. All laboratories of CDSCO and State involved in testing of cough syrup samples for export.