The International Pharmaceutical Excipients Council (IPEC), the US based global association of manufacturers and users of pharmaceutical excipients, is exploring options to set its Indian Chapter to bring in safety and quality guidelines for the excipients produced in India. As the part of expanding its operations to the emerging pharmaceutical markets, the Council is also setting up its arms in China and Brazil.

Setting up of the Indian arm is in conceptual stage and the Council will start discussions with the pharmaceutical organisations, companies and the drug regulatory authority in the country in a week to identify the excipients manufacturers interested to join IPEC, informed David R Schoneker, chairman, IPEC of the Americas. The Council's China Chapter, the fourth IPEC independent association, will be operational within a month or two and the next goal would be to analyse the possibilities of initiating operations in India and Brazil, he added.

"IPEC is an organisation of users, makers and distributors of excipients with its operations in US, Europe and Japan. As the market potential of China, India and Brazil is increasing, we are trying to set up our organisation in these countries. We will talk with the Indian companies to check who would be interested to work with us and how they would like to be the IPEC India, as there is a growing need for a forum of discussion for the excipients related issues in the country, " Schoneker told Pharmabiz.

The Council will then work with the Indian organisation to bring in guidelines for the excipients safety and quality in the country, with the support of IPEC Americas' well established guidelines on good manufacturing practice, good distribution practice and auditing guidelines.

Currently, there are no specific guidelines for manufacturing and marketing of excipients globally but there are guidelines and regulatory norms in some countries. Through the organisation, IPEC is trying to bring in a harmonisation in global standards for excipients manufacturing and distribution.

"As the part of globalisation, currently the pharmaceutical companies are sourcing excipients from all the countries over the world and this has led to serious issues to the quality conscious regulated markets," averred Schoneker. The IPEC is currently working with the Chinese State Food and Drugs Administration (SFDA) for setting up regulatory guidelines for excipients.

While there are excipients companies in India which are of global standards and with operations in US and Europe, some other companies are still having two standards of quality, one for exports and another for Indian customers. The organisation would work for a level playing field in the country to assure safety and quality of the product from all the manufacturers and will support the regulatory authority to bring in appropriate regulations for the purpose.

Over the world, the regulatory authorities were focusing on bringing in regulation for active pharmaceutical ingredients (APIs) even as the majority of the drug product consists of excipients, the inactive pharmaceutical ingredient which is also consumed into human body. With a few issues raised on the quality of excipients used in drugs last year, the US FDA is now more focusing on the safety and quality of excipients and IPEC Americas is supporting the authority to bring in audit information on excipients manufacturers, he added.

The US FDA is also working on a significant legislation to regulate the excipients under quality and safety standards. For IPEC Americas has been developing guidelines for excipients manufacturing and distribution for last fifteen years, the organisation is closely working with the authority for setting up these standards. IPEC's GMP for excipients has already been included in the General Chapter of US Pharmacopoeia.

With more focus on the excipients industry, the US FDA is planning to add mandatory audit reports for the inactive ingredient manufacturers, which is expected to be executed a third party body. IPEC Americas, with its auditing guidelines has ongoing third party certification programmes. The regulatory authority is working with the organisation to establish effective certification programme on this regard, he revealed. IPEC represents the interests of more than 200 companies worldwide at present.