The World Health Organisation (WHO) is planning to revise its Good Manufacturing Practices (GMP) guidelines for active pharmaceutical ingredients (APIs) soon. The move, after a long period since the implementation of the GMP norms for bulk drugs, would force bulk drug manufacturers in the country to invest more on their manufacturing facilities.

According to industry sources, the WHO expert committee meeting would discuss the need and areas of revision in API manufacturing standards in the middle of October 2007. The new guidelines would be in line with the Q7A standard prepared by the International Conference on Harmonisation (ICH), informed sources from WHO.

The organisation is looking up for an upgradation in its present norms, to include more comprehensive and more up-dated standards for pharma ingredients on par with the norms implemented in most regulated markets like US, Japan and European Union (EU). The current WHO GMP for API has been in force from 1992 and has not revised till date.

A WHO official clarifies that the current discussion is 'whether or not to revise' the WHO GMP guideline for APIs. "No decision has as yet been taken. We will be starting to circulate an inquiry soon. The outcome will be discussed in the WHO Expert Committee dealing with quality assurance related issues. Their recommendation will be the basis for WHO's taking future actions," added the official source from WHO.

The GMP certification from WHO is significant for Indian API manufacturers, mainly for the medium and small scale API manufacturers who have been following the 1992 guidelines to market its bulk drug products aggressively in the export market.

"Almost 30 to 40 per cent of the companies in India have WHO GMP for manufacturing bulk drugs. But most of these companies have already upgraded their facilities to ICH Q7A, as it is the basic requirement for exports to the most regulated markets and the rest of them should anyway upgrade their facilities to the revised standards for their export operations," said Narayana Reddy, president of the Hyderabad based Bulk Drug Manufacturers Association (BDMA).

"The overseas customers are not interested in domestic manufacturers unless the manufacturing facility has a latest certification of the highest quality norms," he added. The WHO certified bulk drug manufacturers may need a considerable amount as investment to maintain their business once the guidelines become revised.

The ICH Q7A, adopted by the ICH steering committee on November 2000, has been implemented by the three ICH regions- US, Japan and European Union apart from countries like Canada. The Q7A is designed as an appropriate system for managing quality of products and includes guideline for all API manufacturers, contract manufacturers, agents, re-packers, re-labelers, brokers and traders.

Even though the current GMP norms of WHO also address the same issues, the experts feel that the revision of guideline would strengthen regulations, as the drug manufacturing industry has developed a lot in the last 15 years, the sources added.