The government is planning to the revise the good manufacturing practices (GMP) guidelines and would also consider making Schedule M on par with the WHO-GMP certification.
The Drugs Controller Genera of India (DCGI) is learnt to have asked for inputs from the experts in the field on revising the GMP in tune with the global standards and asked them to suggest the methodologies that could be adopted.
Another persistent demand from the industry is to make Schedule M on par with the WHO-GMP, avoiding the duplication of having both the certifications. At present, WHO-GMP is the mandatory requirement for global markets entry and specifically for countries which had no dedicated regulatory authority. It is also required for supplying drugs under the global diseases control initiatives such as TB, HIV/AIDS, malaria control project funded by Word Health Organization and other international agencies. On the other hand, for domestic supply the manufacturers should be Schedule M compliant only.
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, it is learnt.
“Why should we have this dual-certification system. When we introduced WHO-GMP, there was 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,” suggests former DCGI Dr Prem Gupta.
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.