The nation’s drug regulator has released a draft guidelines on good distribution practices aimed at preventing the circulation of counterfeit, adulterated and inferior pharmaceuticals in the market, reported PTI.
Aligned with the WHO Technical Report Series (TRS), the draft document issued by the Central Drugs Standard Control Organisation (CDSCO) sets standards for the storage and distribution of pharmaceuticals.
These guidelines will apply to all individuals and establishments involved in the storage and distribution process, ensuring quality control from manufacturers to end-users.
“Not of standard quality and spurious products are a significant threat to public health and safety. Consequently, it is essential to protect the supply chain against the penetration of such products,” reads the draft ‘Guidelines on Good Distribution Practices for Pharmaceutical Products’.
It outlines measures to aid stakeholders in fulfilling their roles across different supply chain stages to prevent the entry of substandard products into the market.
The draft proposes incorporating thorough self-inspections by a designated, competent person into the ‘quality system’ in an independent and comprehensive manner.
All pharmaceutical distributors must establish and uphold a ‘quality system,’ with each distribution site appointing a responsible person tasked with ensuring its implementation and maintenance.
Deviations from established procedures must be documented and investigated, with appropriate corrective and preventive actions (CAPA) implemented to rectify and prevent them.
If a product requires recall, it should be segregated during transit and clearly labeled as recalled. If segregation is not feasible, recalled goods must be securely packaged, labeled, and accompanied by necessary documentation.
Prompt notification of any product recall intention must be given to customers and competent authorities in all countries where the product was distributed.
Returned products should be destroyed in accordance with international, national, and local regulations, unless their quality is confirmed satisfactory after critical assessment based on an authorized procedure.
Dispatch records should include product descriptions, batch numbers, expiry dates, and sufficient information for product traceability.
Dispatch records must contain enough information to facilitate the traceability of pharmaceutical products, ensuring transparency and accountability throughout the distribution process.
With inputs from PTI.