COMMENTS ON REVISED DRAFT OF SCHEDULE M PUBLISHED IN 2018 THROUGH GSR 999E
- Ganadhish Kamat General Comments :- This document is largely based on book “Quality assurance for Pharmaceuticals” released by WHO. While the books are written with the intention to provide information including how to do certain things, the law should focus on defining clear expectations without being restrictive / prescriptive about how to achieve those expectations. While most of the recommendations are in right directions and significant improvement over current Schedule M, the document is too detailed and prescriptive to be Schedule of drug law. There are lot of repetitions which can be eliminated thereby reducing length of the document. Many of the requirements given under specific dosage forms are already covered in the main part and some although mentioned under specific requirements are common for other dosage forms too. In view of this all such duplications and contradictions should be deleted / correcte