Institute of Good Manufacturing Practices India
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Schedule M quality revision  equipollent WHO–GMP standards

The government is planning to revise the good manufacturing practices (GMP) guidelines and would also consider making Schedule M on level of equality with the WHO-GMP certification. The DCGI is creating an international regulatory cell at his office with a view to make Indian system on par with the developed countries through different initiatives. The revision of GMP and integration of GMP with Schedule M are also going to be among the main tasks. As India is raising as generic drugs hub so the quality standards are addressable.

“Why should we have this dual-certification system, When we introduced WHO-GMP, there were no Schedule M norms. If India can give guarantee that Schedule M is as good as WHO-GMP, we can do away with one certification. Indian regulators should impress upon other countries and the WHO in this regard,” suggested former DCGI Dr Prem Gupta.

As the WHO-GMP is the mandatory requirement for global markets, this step would avoid the duplication of having both certification, the one according to WHO and the other, for domestic supply, Schedule M. According to statistics, there are over 1350 WHO-GMP certified plants in the country. But industry leaders have pointed out that this number could be nearly doubled if the dual system is dropped. There are more than 1000 another small and medium scale manufacturers who had adopted Schedule M, they claimed. It is also pointed out that there were no uniform standards of GMP from one country to another at the global level, creating hurdles for the exporters. Thus the Uniformity in the standards will help in smoothening of the system.



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