Giving a much needed boost to the pharmaceutical excipients industry in India, the leading names in the industry have joined hands to set up its first ever excipients council in India, International Pharmaceutical Excipients Council (IPEC) India.

The founding members of IPEC India are Ajit Singh of ACG Worldwide and Subodh Priolkar of Colorcon Asia. Indchem International, Micro Labs, Dow Chemicals, Lubrizol India, BASF India, SPI Pharma, and Merck Group are the other founder-member companies.

The council will work actively to promote excipients safety and harmonization of regulatory standards and pharmacopoeial monographs. It will give advice and expertise on excipients and excipients-related regulations. The council will focus its attention on the law, regulations, science and business landscape of the Indian pharmaceutical industry for excipient manufacturers and suppliers. It aims to be a proactive colleague of the Indian pharmaceutical industry associations and federations.

IPEC India has applied for membership of the IPEC Federation and the Federation Board will be discussing this. The other members of IPEC Federation are the Americas, Europe, Japan and China. Internationally, the IPEC Federation is the leading federation of the pharmaceutical excipients industry and has over 250 members across all affiliates.  The IPEC Federation provides a unified voice which promotes the proper use of excipients in medicines as a means of improving patient treatment.

Says Subodh Priolkar, “This is something that the Indian pharma industry has been crying out for. India is one of the world’s largest manufacturers of pharmaceuticals and excipients, which are a critical part of any formulation. It is critically important that we have an industry association that works on these matters.”

According to Ajit Singh, IPEC India will have three main areas of activity. “ In the first place it will represent its members i.e. excipients manufacturers, distributors and finished drug makers to government. It aims to work with relevant authorities and help ensure that regulations are not just streamlined and useful for manufacturers, but also represent the best efforts in reaching and improving upon global GMP standards for both, the Indian market and exports.

“Secondly, via EXCiPACT and other initiatives, IPEC India will set and maintain standards for Indian excipient manufacturers and suppliers. From best practices in manufacturing, to audit guides and templates that will ensure not just a level playing field, but a high reliability quotient for pharmaceutical manufacturers when they use these excipients.

“Finally, IPEC India aims to be a knowledge base and resource centre for the Indian excipients industry, conducting workshops and seminars, organising conferences where training can be given regarding best practices, as well as providing other suitable forums in which knowledge and best practices can be institutionalised in member companies.”

EXCiPACT (www.exipact.org) is a voluntary international scheme to provide independent third party certification of manufacturers, suppliers and distributors of pharmaceutical excipients. So the EXCiPACT scheme provides independent certification of manufacturers and suppliers of pharmaceutical excipients as a means of ensuring patient safety, through supplier quality, while minimising the overall supply chain costs.

The Board of Directors is responsible for the management of the EXCiPACT organization. The members of the Board are appointed by the General Assembly. The members consist of a representative of four of the five founding project consortium associations – FECC, IPEC-Europe, IPEC-Americas and PQG.

Given the involvement of IPEC in the development, and current corporate governance of EXCiPACT, IPEC India is keen to be in the vanguard of bringing this certification to India.

“It is natural for IPEC India to lead the way in introducing EXCiPACT Certification to India. It will be part of our programme to ensure that Indian excipient manufacturers and suppliers can independently verify the quality of their products, both for the internal market, and for export. We are currently working with IPEC Federation to decide on the best way forward, and hope to make further announcements about these exciting developments in the near future,”says Ajit Singh.