Expansion of Quality Improvement Norms: More Pharma Products Eligible for Export
According to a top official from the Director General Foreign Trade (DGFT), more pharmaceutical products can be included under mandatory quality improvement regulations for export from India if the Ministry of Health advises accordingly. The official emphasized that all pharmaceutical products must meet global standards and quality requirements. This statement follows a recent notification from the Directorate General of Foreign Trade, which stated that cough syrup exporters will be required to test their products at specified government laboratories before obtaining permission for outbound shipments starting from June 1.
The decision to implement these measures was prompted by concerns raised globally regarding the quality of cough syrups exported by Indian companies. The focus on cough syrup is just the beginning of an ongoing effort to ensure that all cough syrups exported from India meet the minimum quality standards. To achieve this, they will undergo testing at designated laboratories before being exported.
The official further stated that any necessary steps for quality improvement in the pharmaceutical sector will be taken based on the advice of the Central Drugs Standard Control Organization (CDSCO). If CDSCO and the Ministry of Health determine that more stringent global benchmarks are required for other pharmaceutical products, similar quality improvement regulations will be implemented for their export from India.
The DGFT’s notification on Monday clarified that the export of cough syrup will be permitted, provided that export samples are tested and a certificate of analysis is issued by any of the specified central government laboratories. These laboratories include the Indian Pharmacopoeia Commission, regional drug testing labs (RDTL) in Chandigarh and Guwahati, central drugs labs (CDL) in Kolkata, central drug testing labs (CDTL) in Chennai, Hyderabad, and Mumbai, as well as drug testing labs accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL) in various state governments. The implementation of these measures will commence from June 1, 2023.
