Schedule M and Its Revision. The Need of the Hour

      Аннотация: The text describes the Schedule M-Good Manufacturing Practice (GMP) scenario in Indian pharmaceutical market and its revision. As India is now holding a very good position in the world pharmaceutical market, moreover has a high share on the world pharmaceutical market, so for a better future and consistency in growth GMP is the sole key factor. As the product produced based on the guidelines of GMP, one can have confidence of all regulatory agency compliance. And this will further increase the quality of the product and the position of the pharmaceutical manufacturer. A quality product means a product with high safety, efficacy, and definitely high potency. As the chances of contamination and cross contamination increase with the complexity of product, some sort of changes need to be made in the guidelines of GMP which will definitely help the pharmaceutical producer to get upgraded with the flow of quality and safety for pharmaceutical product. Thus, the revision of GMP is an essential phenomenon for consistent growth of pharmaceutical firms.

Ключевые слова: Schedule M, Good Manufacturing Practice, revision, US FDA, MHRA