India Introduces Stringent GDP Standards to Combat Counterfeit Drugs
India's Central Drugs Standard Control Organisation (CDSCO) has released an upgraded draft of Good Distribution Practices (GDP) for pharmaceutical products, aiming to combat the circulation of substandard and falsified medicines. Published on August 9, this document marks a significant step forward by elevating its status to a formal Schedule, making it a mandatory standard rather than just a guideline.
The new GDP draft outlines stringent requirements for the storage, transportation, dispatch, and receipt of pharmaceutical products. It also addresses critical areas such as labeling, product recalls, returns, and the handling of spurious, misbranded, adulterated, and substandard medicines. By enforcing these standards, the CDSCO seeks to ensure the integrity of the pharmaceutical supply chain from end to end.
One of the draft’s key focuses is enhancing the traceability and accountability of pharmaceutical products throughout the distribution process. The draft encourages collaboration among all stakeholders in the supply chain, including manufacturers, distributors, and healthcare providers, to ensure that medicines reaching patients are safe, effective, and of the highest quality.
The introduction of this draft reflects India’s ongoing commitment to strengthening its regulatory framework to protect public health. A 30-day public comment period has been initiated, allowing stakeholders to provide feedback before the document is finalized. The new GDP standards are expected to play a crucial role in curbing the proliferation of counterfeit drugs in the Indian market, ensuring that only authentic and quality-assured pharmaceutical products reach consumers.
