India releases draft guidelines on Good Distribution Practices

The Central Drugs Standard Control Organisation (CDSCO) in India has developed draft guidelines on Good Distribution Practices (GDPs) which are up for consultation for three weeks. The draft guidance outlines CDSCO expectations for all companies in the supply chain in terms of personnel, quality systems and other factors that are essential to GDP compliance.

The draft guideline has been created to give all people and organisations who are involved in the storage and distribution of drugs advice on how to ensure that products meet quality standards and are authentic. The 21-page document addresses a variety of topics, ranging from the training of staff through to how to map the temperature of storage areas.

CDSCO expects companies to establish responsibilities for all supply chain employees and ensure that they are properly trained. Each company must give one person responsibility for ensuring a quality system is implemented and maintained. All distributors of pharmaceutical products are required to establish and maintain a quality system that is supported by a documented quality system. It is expected by CDSCO that managers will ensure product quality is not put at risk by the overburdening of employees with responsibilities.

Additional sections of the guidelines include the documentation required to comply with GDPs. According to the guidance, companies should ensure that drugs can be traced the full length of the supply chain, from the manufacturer to retailer, using the available documentation. CDSCO has advised companies to retain documents until one year after the expiry date of the product they relate to.

Falsified medicines are also addressed in the guidance. CDSCO advises companies to respond to the discovery of falsified products by separating them from legitimate products, and labelling them as not for sale. Companies should also inform national regulatory authorities about its discovery as soon as possible and suspend the sale and distribution of any suspect products. If the authorities confirm that the products are falsified, then they will make a formal decision regarding their disposal.

To read the draft guidelines on GDPs for pharmaceutical products, please click here.