News about GMP/cGMP


CDSCO: Draft of Indian Schedule M published

According to, the Indian regulatory authority CDSCO has published a draft version of the revised Schedule M. However, the document is currently only available in Indian language.

As further reported, the scope of the regulatory requirements on GMP has more than doubled. It is also said that the document should largely correspond to the corresponding WHO document on the basic principles of GMP. This standardization is closely linked to the planned inclusion in the PIC/S. At present, the WHO standards are only met by the larger pharmaceutical players in India. Around 20% of small and medium-sized pharmaceutical manufacturers also produce at this level. According to, this currently leads to a "dual quality system".

When a final version of the revised draft on GMP becomes reality, a uniform quality system or a corresponding risk management will be required. These standards would subsequently open up the export market for a further number of Indian pharmaceutical manufacturers. The Indian government is speculating on this.

The draft can be publicly commented on until 5 November 2018.


CDSCO: Gazette of Notification