The manufacturers are exporting the Cough Syrup to USA, UK, Canada, EU, Japan, Australia, Singapore, Republic of Korea and Switzerland, the requirement of testing from the laboratories may be waived off, in view of approval granted by these countries regulatory agencies for plants or section engaged in manufacturing and export of Cough Syrup, said in a notification by DGFT.
It is further mentioned in a notification that if Cough Syrup is manufactured in a plant/section approved by the regulatory agencies for above mentioned countries for any product, such Cough Syrup shall be permitted to be exported to any country without testing as mandated.
Last year, the Government of India informed that they will be permitting export of cough syrups, subject to the export sample being tested and production of Certificate of Analysis issued by any of the Central Government Laboratories and any NABL accredited State Drug Testing Laboratory.
This testing was made mandatory after the World Health Organization (WHO) alerted against Indian made cough syrups linked with the death of children in Gambia. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited, in India.
The mandatory testing of the export sample of Cough Syrup under HSN 3004 is exempted in certain situations as mentioned above in accordance with the required GMP benchmarks or standards.
