COMMENTS ON THE DRAFT GUIDELINE ON GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL PRODUCTS
- Ganadhish Kamat On 4th of April 2024, CDSCO issued draft guideline on Good distribution practices for Pharmaceutical products. This draft is similar to the draft issued for comments in 2018 with few additions like Quality Risk Management , Quality system requirements, Management review etc. As usual the guideline has been copied from WHO guideline without trying to understand the distribution chain within India and evaluating suitability of WHO guideline for distribution within India. Obviously there are many clauses, statements and terms which are not applicable in India and create confusion rather than providing clarity. I wish CDSCO had applied the principles of Quality Risk Management (which it is trying to introduce everywhere) while finalizing the draft. Given below are some of my observations / comments on the guideline. Since CDSCO does not pay any attention to comments submitted by industry experts, this time I have decided not to submit my commen