SMPMA asks Govt to Approve the Export of Cough Syrups based on Certificates of Analysis Granted by NABL accredited Private Testing Labs

To avoid losing business to China, the Small and Medium Pharma Manufacturers Association (SMPMA) has urged the Drugs Controller General of India (DCGI) and the Directorate General of Foreign Trade (DGFT) to prioritise the export of cough syrups from India. According to SMPMA, this must be accelerated on the basis of a Certificate of Analysis (COA) provided by a private testing laboratory accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in the country. This will prevent China from gaining a monopoly on cough syrup exports to crucial export destinations such as Gambia.

“The Medicines Control Agency (MCA) of the Government of Gambia with reference to the letter dated June 15, 2023 has appointed a private laboratory in India to do the quality control testing of medicines being exported from India to Gambia. He went on to say that on behalf of the SMPMA, he would like to propose that appropriate and substantial numbers of licenced private laboratories across India be allowed to satisfy the urgent needs of Indian cough syrup exporters. This will assist exporters in having their cough syrup consignments tested and CoAs granted as soon as possible in the interest of export activity.

SMPMA is making all efforts in enhancing its competitive edge to avail the opportunities in exports of pharmaceutical products including exports of cough syrups. Our competitor countries including China are set to go ahead in their export performance due to delay in clearance from the accredited government laboratories. As per the DGFT's notification dated May 22, 2023 and in compliance with the DCGI instructions, cough syrups meant for exports have to be mandatorily be tested by the accredited government laboratories and to obtain COA before exports of the same. “Owing to heavy backlog in these accredited government laboratories, clearance of the exportable cough syrups are taking inordinate delays eventually leading either to cancellation of export orders in terms of their agreements or having the cut off shelf lives of such cough syrups. This is adversely affecting the overall exports performance of the pharma sector,” SMPMA highlighted.