India releases draft guideline on Good Distribution Practices (GDP)

The Indian regulatory authority CDSCO (Central Drugs Standard Control Organization) has published a 21-page draft on Good Distribution Practices (GDP) for pharmaceutical products.

The draft covers topics that are well aligned to other good distribution practices, and is aligned to the ICH framework.

It is good to see India moving ahead in adopting best practices. This is a huge market, a growing source of production and it will be a huge center of innovation in the near future. It is important for CDSCO to continue to push forward in a better regulatory regime and to tighten their quality practices.

The guidance contains some of my favorite themes of GDP (and other pharma) practices, including::

  • Each company must hold one person responsible for ensuring a quality system is implemented and maintained.
  • All distributors of pharmaceutical products have to establish and maintain a quality system supported by a documented quality system.
  • Senior management has to ensure that all parts of the quality system are adequately resourced with competent personnel and suitable and sufficient premises, equipment and facilities.

The responsible person/quality person model is one of the more problematic aspects of our field. Yes, there is someone who is responsible for quality, its called the officers of the company. But this idea that one person sits on the top of the pyramid and makes ALL the best decisions is a problematic thing that regulations tend to enshrine.


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