Indian Pharmacopoeia Commission (IPC) has recommended inclusion of marketing authorization to Phytopharmaceuticals as a 'drug' in the Drugs & Cosmetics Rules, by way of an addition. This would give a drug status to plant based formulations.

The commission is also looking at using the strength of the network of the Council of Scientific and Industrial Research (CSIR) labs for the preparation and certification of markers, required for testing plant based ingredients and products introduced in IP 2007 and its addendum 2008. In this regard, it has adopted testing for quantitative assay of at least one marker to ascertain the bio activity in the herb.

The Director of IPC has released order for providing funds for appointment of two scientific staff and contingency amounts at four of the CSIR national labs, which are CIMAP, NBRI, CDRI at Lucknow and IIIM, Jammu for preparing the botanical and phytochemical reference substances for IPC, Dr D B Anantha Narayana, head: Herbals Research- Unilever Research India, Bangalore and chairman of the Herbs and Herbal Products Committee, IPC told Pharmabiz.

IPC has just announced many posts for appointment of scientific and technical staff. It has also decided to bring out a new and revised edition of IP in 2009 in an email interaction.

Efforts are also on to build capacity and competencies in quality testing. "Therefore future is promising for IPC as it will look at generating revenues from the training and workshops it would conduct to educate the industry and from the sale of its publications and reference substances. It will also start a publication which will in advance provide details about the future monographs, amendments and papers that deal with reviews of methods, standards, technologies. These initiatives will make IPC the agent which indicates 'regulations drive innovations', stated Dr Narayana.

"If IP moves in this direction by regularly updating the monographs and publish them periodically, it will become an official document for drugs and formulations made in India. It will also project the leadership in the area of biological products. IP will lead the way herbs and natural products are assessed for quality and make them become more easily accepted by other countries," said Dr Narayana.

"Going by the considerable activities in the area of reverse pharmacology approaches and evidence based herbal medicines being brought out through 'golden triangle project' involving Department of Ayush, CSIR labs and private R&D labs, IP is the right place to publish successful products' quality specifications. CSIR labs need to play a bigger role in IP. India is far behind China which has so many monographs for raw herbs as well as Polyherbal Traditional Chinese Medicines (TCM), with highly science driven monographs in their pharmacopoeia. Therefore CSIR labs should take the leadership role to develop monographs for at least 50 to 60 raw herbs as per standard operating procedures (SOPs) of IP, perform ring testing and provide them to IP for inclusion in IP 2009.