It is now mandatory for exporters of cough syrups to get samples tested in designated laboratories prior to export. The Directorate General of Foreign Trade (DGFT), Department of Commerce, has notified an amendment in the Export Policy of Cough Syrup.
According to the revised export policy, “cough syrup shall be permitted to be exported subject to the export sample being tested and production of Certificate of Analysis (CoA) issued by the designated laboratories”, said the DGFT notification.
As for the existing export policy, there is no need for a CoA. The revised policy will come into effect from June 1. According to the notification, the export samples can be tested at Indian Pharmacopoeia Commission, Ghaziabad; Centra Drug Laboratory at Kolkata, West Bengal; Central Drug Testing Laboratories (CDTL) at Chennai, Mumbai, Hyderabad; Regional Drug Testing Laboratories (RDTL) at Chandigarh and Guwahati and any NABL accredited State Drug Testing Laboratory.
It may be recalled that in an alert issued in October last year, the World Health Organization (WHO) identified four products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — as substandard in Gambia. The manufacturer of the products was Maiden Pharmaceuticals Ltd, Haryana.
In January this year, the WHO again warned against use of two Indian cough syrups that have been allegedly linked to the death of 18 children. The WHO said the products, manufactured by Marion Biotech, were “substandard” and that the firm had failed to provide guarantees about their safety.
R Uday Bhaskar, Director General, Pharmaceuticals Export Promotion Council (Pharmexcil) said: “The final guidelines and modalities of implementing the revised export policy are awaited. We hope the revised policy will not lead to any delays for the exporters.”
One of the registered exporters of cough syrups told businessline on the condition of anonymity that the new policy will lead to red tape and delays in certification. “The onus on proving the quality should rest with the manufacturer. Some allegations which have been refuted by India need not lead to a big shift in the policy. We are not sure if the designated labs have the adequate manpower or the infrastructure to support regular testing and certification of the samples and the cost of testing,’‘ he added.