Schedule M soon to be at par with WHO-GMP certification

Indian government plans to consider Schedule M to be at par with the WHO-GMP guidelines and revise the good manufacturing practices (GMP) standards. Recently, the Indian drug regulator, the Drugs Controller General of India (DCGI), has been receiving information from the industry experts regarding the GMP guidelines. This is related to the GMP standards being in line with the global standards and the possible methods of adopting those also being considered.

Additionally, Schedule M is gaining much attention in the industry and demands for making it on par with the WHO-GMP, while ensuring that there is no duplication of both certifications have been constant. Currently, WHO-GMP is the gold standard and an obligatory requirement for entry into the global markets. This is more so for those countries that do not have a special dedicated regulatory authority. Even for global disease prevention and control initiatives like tuberculosis or AIDS control programme, it is a mandate.

While this is true for projects funded by international agencies like WHO, those manufacturers involved in domestic supply need to be compliant only to Schedule M. With the attempts of attending to Schedule M, DCGI aims at creating an international regulatory cell to make the Indian drug regulatory system equivalent to the global standards in the developed countries.