The Directorate General of Foreign Trade (DGFT) has issued new guidelines for cough syrup exporters, requiring them to conduct rigorous quality checks and obtain a certificate of analysis from designated government laboratories before exporting their products. This directive comes in response to global concerns regarding the quality of cough syrups exported by Indian companies. India exported cough syrups worth USD 17.6 billion in 2022-23, making it crucial to ensure the safety and quality of these pharmaceutical products in the international market.
Strengthening Quality Checks for Cough Syrup Exports
Starting from June 1, 2023, cough syrup exporters will need to adhere to new regulations aimed at enhancing the quality assurance process. The export of cough syrup will be permitted only if export samples are tested and a certificate of analysis is obtained from one of the designated laboratories. These measures ensure that cough syrup formulations meet the required quality standards before being allowed for export.
Designated Government Laboratories
The specified central government labs include the Indian Pharmacopoeia Commission, regional drug testing lab (RDTL – Chandigarh), central drugs lab (CDL – Kolkata), central drug testing lab (CDTL – Chennai Hyderabad, Mumbai), RDTL (Guwahati), and the NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited drug testing labs of state governments. These laboratories play a crucial role in verifying the quality and safety of cough syrups before they are exported.
Reinforcing India’s Commitment to Quality Assurance
The central government’s decision to implement pre-quality checks for cough syrup formulations emphasizes India’s commitment to ensuring the quality of pharmaceutical products exported from the country. By conducting thorough testing of finished cough syrup products, India aims to uphold its reputation as the largest provider of generic drugs globally.
Collaboration for Smooth Implementation
To facilitate the smooth implementation of these new guidelines, the Ministry of Health and Family Welfare (MoHFW) will collaborate with state governments and exporters. This partnership will help address any challenges that may arise during the testing process and ensure that the testing requirement is seamlessly integrated into the export procedures.
Enhancing Pharmaceutical Industry Standards
This move comes after incidents involving India-made cough syrups allegedly causing the deaths of children in Gambia and Uzbekistan. With India’s significant contribution to the global pharmaceutical market, it is crucial to maintain high-quality standards. India is the largest provider of generic drugs worldwide, meeting over 50% of global demand for vaccines and a substantial portion of generic demand in the US and medicine in the UK. These new guidelines further strengthen India’s position as a key player in the global pharmaceutical industry.
Excerpt
The Directorate General of Foreign Trade (DGFT) has issued new guidelines for cough syrup exporters, requiring them to conduct rigorous quality checks and obtain a certificate of analysis from designated government laboratories before exporting their products.
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