India's Central Drugs Standard Control Organisation (CDSCO) has published a new draft guidance document on Good Distribution Practices (GDP) for pharmaceutical products, aimed at driving substandard and falsified medicines from the market.
The new version published (PDF) on August 9 is a departure from earlier drafts because it has been upgraded to the status of a formal 'Schedule' document, rather than a non-mandatory guideline. Its publication by the CDSCO has triggered a 30-day comment period before it is finalised.
It sets out requirements for the storage, transportation, dispatch and receipt of pharmaceutical products, including labelling, and how to deal with recalls, returns, and spurious, misbranded, adulterated and substandard medicines.
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