IndiaThe recent amendments to the Drugs and Cosmetics Rules, 1945, have been welcomed by Ayurvedic medicine manufacturers in Kerala as they aim to improve compliance with international standards. Key changes include making manufacturer licenses permanent rather than requiring periodic renewal, mandating microbiologists with specific qualifications, and allowing accelerated stability studies to determine product shelf life. These changes are expected to enhance product quality, streamline operations, and support exports. However, critics argue that removing periodic license renewals could weaken regulatory oversight, especially given existing shortages of drug inspectors and increased influx of products from other states. Smaller manufacturers may struggle with the new requirements related to Good Manufacturing Practices (GMP) and digital traceability.
Bias read (Center): The article presents both supportive and critical perspectives on the amendments. It highlights the positive implications for the Ayurvedic industry, including alignment with global standards and reduced bureaucracy, while also acknowledging concerns from regulators about potential weakening of the药
