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CDCSO releases guidelines for distributing pharmaceutical products in market to prevent the spread of counterfeit drugs, reports ET HealthWorld.

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CDCSO issues distribution guidelines for pharma products in market to curb substandard medicines, ET HealthWorld

The draft guidelines on good distribution practices have been released by the country’s drug regulator to prevent the entry of ‘spurious,’ ‘adulterated,’ and ‘sub-standard’ pharmaceutical products in the market, according to PTI. The Central Drugs Standard Control Organisation (CDSCO) issued the draft guidance document, aligning with the WHO Technical Report Series (TRS) on good storage and distribution practices for such products.

The guidelines apply to all individuals and establishments involved in the storage and distribution of pharmaceutical products, from manufacturers to individual dispensers. The draft emphasizes the importance of protecting the supply chain against the infiltration of sub-standard products to safeguard public health and safety.

Stakeholders are urged to implement measures outlined in the document to prevent the entry of sub-standard products. The guidelines stress the importance of self-inspections within the quality system and the designation of responsible individuals at distribution sites to ensure compliance.

Deviation from approved procedures must be recorded and addressed, with corrective and preventive actions in place to rectify and prevent future occurrences. In the event of a product recall, appropriate measures must be taken during transportation, including proper labeling and documentation.

The guidelines also specify the proper disposal of returned products in accordance with international, national, and local regulations to ensure environmental protection. Records of dispatched products must contain detailed information for traceability purposes, ensuring transparency and accountability within the distribution process.

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