Drugs regulatory body may waive testing requirement for cough syrups exported to certain countries

New Delhi: The Central Drugs Standard Control Organisation (CDSCO) is considering a proposal to waive the need for testing cough syrups for export to certain countries after having received a representation from stakeholders seeking such exemption, official sources said on Tuesday. In May last year, the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry had made it compulsory for cough syrup manufacturers to get samples of their products tested at specified government laboratories from June 1 before getting permission for outbound shipments. The direction had come after quality concerns were raised globally over cough syrups exported by Indian firms.

Now, the CDSCO, the apex drugs regulatory authority, is examining a proposal to waive the requirement for testing cough syrups being exported to the US, the UK, Canada, the European Union, Japan, Australia, Singapore, Korea and Switzerland at the prescribed laboratory, the sources said.

Further, if a cough syrup is manufactured in a plant or section approved by the regulatory agencies of these countries for any product, it may also be allowed to be exported to any country without testing at the prescribed laboratory, they said.

While the CDSCO is considering waiving the testing requirement, the sources said that according to the latest data, around 353 of 7,087 batches of cough syrups that were tested were found “not of standard quality” on various parameters, including contamination of toxic diethylene glycol and ethylene glycol.