CDSCO Consider Bringing Good Distribution Practice Guidance into Schedule

Latest circular issued by CDSCO on Good Distribution Practices (GDP) indicate that the guidance on GDP could be incorporated as a schedule in Drugs and Cosmetics Act, 1945. CDSCOs Drug Consultative Committee (DCC) apprehend that due to non-mandatory nature of guidelines, maintenance of storage condition of drugs during transit till wholesale and retail level is not being ensured by manufacturers.

Guidelines are non-mandatory documents issued by regulatory authorities. Compliance with guidelines is voluntary, and there are no legal consequences for non-compliance. Whereas Drugs and Cosmetics Act (D&C Act) is a legal framework governing the manufacture, sale, and distribution of drugs and cosmetics in India and Schedules within the Act detail specific provisions and requirements. When a requirement is incorporated into a Schedule, it becomes legally binding for all stakeholders.

The draft guideline on GDP prepared in line with the WHO TRS guidelines and the circular is published in the CDSCO website on 6^th August, 2024 and available for comments by stake holders within 30 days. The guidance published by the CDSCO is applicable to all persons and entities involved in any aspect of storage and distribution of the pharmaceutical products. It includes manufacturers of bulk and finished products, wholesalers, suppliers, distributors, logistics providers, traders, transport companies. The guidance lays stress on the entities involved in the storage and distribution to have an effective and documented Quality system. The Quality system should have a documented quality policy, clearly defined roles and responsibilities of personnel and organisational structure, address written agreement between individual entities involved in the distribution chain. Personnel involved should be trained and there should be periodic management reviews. The Quality system should have adequate documentation and traceability of products received and distributed. Adequate documentation is also required to be maintained about the storage conditions including temperature and humidity; if documents are maintained electronically the system should be validated. The storage areas should be adequately secured to prevent unauthorised entry, should have written program for pest control, materials should be handled as per FEFO (First Expiry First Out) with appropriate system in place to ensure the same. Materials should be stored and transported as per conditions recommended by manufacturer and the storage areas shall be temperature mapped. Narcotics and other dependence producing substances should be transported in safe and secure containers. Vehicles and containers for transportation of pharmaceutical products shall be clean and dry, free from rodents, vermin, birds, pests. All documentation pertaining to receipt, distribution, storage shall be stored and retained to prevent unauthorised access, loss and damage. There should be procedure to handle recalls and the quality system also shall have procedures to identify spurious, misbranded and adulterated products. Consignments of imported products shall be stored at appropriate conditions at port of entry for as short a time as possible. Quality system should also provide for self inspection to monitor implementation and compliance to the Good Distribution Practices.  

CDSCO Circular on Draft Guidance on Good Distribution Practices (6 August 2024).