USP to revise monographs to boost India’s bulk exports
Ananth Iyer – Mumbai
In what could be a major boost to bulk drug exports from India to the US, the United States Pharmacopoeial Commission, which recently collaborated with the Indian Pharmacopoeial Commission to upgrade and harmonise IP standards, is now seeking India’s assistance to design new monographs for generic bulk drugs to include alternate route of synthesis different from that of innovator’s process.
This means that the new monographs will also include standards of monographs with impurity profile common to Indian manufacturers. As of now, USP monographs are based on innovator’s synthesis and do not recognise alternate syntheses along with its ensuing impurity profiles. USP is in the process of compiling an Asian edition which will include alternate syntheses. The edition will be launched in January 2003.
The idea was first mooted by Dr Roger Williams, CEO, USP Commission during a meeting with Indian officials at IPC Delhi. Industry sources say that Dr Williams wanted to harmonise monographs sent by Indian companies to the US FDA through Drug Master Files with USP. Currently, DMF submitted by Indian companies to US FDA is not in harmony with the USP.
The harmonisation will also cut down validation requirement such as toxicity studies on lower animals to demonstrate impurity profiles, industry officials say. For instance, USP monograph for salbutamol has a maximum impurity limit of 2 per cent. On the other hand, the EU monograph specifically lists 16 impurities with 0.1 per cent limit for each impurity and 0.5 per cent cap on total impurities. This means that for any new impurity, manufacturers have to demonstrate impurity limits through toxicity studies on lower animals to get the approval of US FDA.
The Asian edition of USP aimed to upgrade the USP on par with the EU Pharmacopoeia in quality and level of sophistication, a senior industry official who is also a member of the USP Advisory Committee told Express Pharma Pulse. ‘‘The US sees India as a major base for producing bulk actives and there are positive trends to indicate that US may source as high as 70 per cent of its bulk requirements from India as they are vary of the quality of bulk actives produced by China. Thus, the Asian edition of USP will be recognised by the US FDA.’’
The USP is also looking at India as a potential market for reference standards and hence it is investing in India to educate the scientific community on understanding USP standards and how to use it. A two day work-shop has been scheduled at Hyderabad in September for this purpose, the official added.
USP is also assisting India to lay down specifications for OTC medications, nutraceuticals, biogenerics and biopharmaceuticals. A 15-member Joint Quality Communications Group has been formed comprising distinguished industry and regulatory experts from both sides.