Pharmaceutical quality

                                                       - 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

  - 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

     -   Ganadhish Kamat Background - Government of India amended the Drugs Rules 1945 on 28th December 2023 vide GSR 922(e) to revise the Schedule M. While the revised document has lot of flaws (as mentioned in my earlier blog) it is significant improvement over the existing document and if implemented correctly by all manufacturers, will result in significant improvement in the Quality of drugs in India. The revised Schedule M comes in effect from 28th June 2024 for large manufacturers (Turnover >250 crore) and from 28th December 2024 for small and medium scale manufacturers (Turnover <250 crore). The revised Schedule M is based on WHO TRS 986 published in 2014. So hopefully the manufacturers who are exporting their products and inspected by WHO must be already complying to revised rules. The question remains of other manufacturers who exclusively make products for distribution in India.  Challenges in compliance - While revision of the Schedule M is the first step of improving