The South Asian pharmaceutical Excipients Council, the association of excipient manufacturers and traders affiliated with PAMDAL, wants the government to frame a set of guidelines and standards for the manufacturing of excipients in India.

Manufacturing of excipients is confined to only a few units in the unorganized sector in India and a good part of the country's requirements are being met through imports.

Excipients and additives are not just inactive materials but can also interact with pharmaceutical products. And the use of low quality and substandard excipients in pharmaceutical manufacturing could be quite harmful. Very few in the industry and the government have realized this fact.

According to Ajit Singh, current chairman of SAPEC and former president of PAMDAL, the nomenclature and basic definition of excipients itself have to be modified in such a way that the sector gets an important identity and due recognition in the field of pharmaceuticals. "It is time for SAPEC to wake up and act towards the growth of this unorganized sector," Singh said.

Internationally, there have been new regulations introduced recently concerning the selection, use, testing and even distribution of excipients, as these products are recognized as having decisive role in the quality and stability of pharmaceutical products. Currently, the International Pharmaceutical Excipients Council (IPEC) of USA, IPEC Europe and JPEC of Japan are very active bodies abroad interacting with each other, organizing international conferences for updating and sharing of information and also to prepare guidelines for the benefit of the products and industry.

Since the number of manufacturers of excipients and such materials in the South Asian region especially in India has been increasing, the SAPEC has now decided to formalize its working by enlarging membership and also by setting up a managing committee. It would also affiliate with other parallel international organisations, Ajit Singh said. "We see a growing need for an active SAPEC and it needs to work closely with the governments of India and other South Asian countries in defining standards. It will also arrange workshops and publications of monographs and will communicate relevant world wide information on excipients to its members," he added.

SAPEC was formally launched in 1998 during the IPCA-FAPA International Pharma Congress at Mumbai and is currently operating as a division of PAMDAL.