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COMMENTS ON THE DRAFT GUIDELINE ON GOOD DISTRIBUTION PRACTICES FOR PHARMACEUTICAL PRODUCTS

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                           - 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
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FAQ - Revised schedule M

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                                                       - Ganadhish Kamat The Government of India amended Drugs and Cosmetics Rules 1945 to revise the Schedule M. Since there are significant changes with respect to existing rules, some manufacturers especially the small and medium manufacturers may find it difficult to understand the requirements specified in the revised document and may face difficulty in complying with the same. This document has been created to help Pharmaceutical manufacturers in India to comply with revised Schedule M. Incase you have any additional question, please post them in the comments. The question has to be specific, referencing relevant part number and section. I will be periodically updating this document to include responses to new questions if any.  What are the key changes in the revised Schedule M? Revised schedule M has following key changes - Inclusion of new concepts such as  Pharmaceutical Quality systems (PQS),  Quality Risk Management,  Product
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Tackling the menace of fake drugs in India

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  - Ganadhish Kamat Mena ce of fake drugs is not new in India. Reports of seizure of fake drugs and arrest of culprits keep appearing in the news at periodic intervals from various parts of the country.  Last few days I came across many such articles about seizure of fake medicines in various parts of India. Some prominent cases include - 25 crore fake cancer drug case busted by Delhi police where the suspects filled empty vials of international and Indian brands with antifungal drug fluconazole. Case of spurious medicines such as Ultracet, Amaryl, Gluconorm, and Defcort tablets manufactured in two UP cities (Gaziabad & Shamli) cracked again by Delhi police. Case of fake   medicines (mostly antibiotics like cephalosporins and amoxycillin-clavulanic acid) manufactured by Meg life science (a fictitious company with headquarter in Sirmaur district of Himachal Pradesh) containing chalk powder and starch valued at Rs 33.3 lakh seized in Telangana by the Drugs Control Administration. Ano
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