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Regulator releases distribution guidelines to prevent substandard pharmaceutical products in the market



Regulator issues distribution guidelines to ensure no substandard pharma products in market, ET HealthWorld

The Central Drugs Standard Control Organisation (CDSCO) has released draft guidelines on good distribution practices to prevent the circulation of spurious, adulterated, and sub-standard pharmaceutical products in the market. The guidelines are aligned with the WHO Technical Report Series and aim to safeguard public health and safety. All stakeholders involved in the storage and distribution of pharmaceutical products are expected to adhere to these guidelines.

The draft guidelines recommend the implementation of self-inspections by a designated competent person as part of the quality system. It also emphasizes the appointment of a responsible person at each distribution site to oversee the implementation and maintenance of the quality system. Any deviations from established procedures must be documented and investigated, with corrective and preventive actions taken as necessary.

In the event of a product recall, the guidelines stipulate that the recalled products should be segregated during transit and clearly labeled. If segregation is not possible, the products must be securely packaged and accompanied by appropriate documentation. Prompt notifications about product recalls must be given to customers and competent authorities in all countries where the product has been distributed.

Returned products should be destroyed in accordance with international, national, and local regulations unless their quality is deemed satisfactory after a thorough assessment. Records of product dispatch should include detailed information for traceability purposes. These guidelines aim to enhance the quality and safety of pharmaceutical products throughout the distribution chain.

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