The Karnataka Indian Medicine Manufacturers Association (KIMMA) has urged the government to include herbal extract units under the ambit of NMPB's notification which asks the Ayurveda, Siddha and Unani (ASU) drug manufacturers to submit record of raw materials used by these units to assess the quality parameters.

KIMMA's insistence comes in the wake of the National Medicinal Plant Board's (NMPB) notification dated July 8, 2008 calling to submit record of raw materials used by ASU drug industry across the country. The main objective is to ensure the quality standards. However, it is also important for NMPB to include the herbal extracts companies to provide inputs, JSD Pani, president, KIMMA told Pharmabiz.

The herbal extract sector in the country is huge and unorganized. There are only a few organized players in the space. These include Sami Labs, Natural Remedies, Phytotech Extracts in Karnataka, Chemiloids in Andhra Pradesh, Ayush Herbs Pvt. Ltd. in Himachal Pradesh, to name a few. But it is vital to keep tabs on the raw materials source and quality practices, added Pani.

According to Dr D B Anantha Narayana, director, Regulatory Affairs-South Asia, (Foods, Home and Personal Care), Unilever Research India, Bangalore and Chairman of the Herbs and Herbal Products Committee, IPC, there are at least a dozen manufacturers who produce high quality extracts in their own good manufacturing practices (GMP) complied factories. There are more than 50 manufacturers who claim they can supply quality extracts. But all is not well with this sector. It is facing difficulty to provide credible scientific data and information about such phyto-compounds with regards to their safety and efficacies.

"More often the end users of phyto-compounds wish to rely on the supplier for such support information in the form of dossiers, well characterized chemistry and composition of information on the herbal compounds, apart from safety information. Each end user would be willing to make a formulation of their own and hence will invest in generating efficacy data to claim support," stated Dr Narayana.

So far, there has been no formal representation from the herbal extract companies asking the regulatory authority to introduce quality norms, said industry sources.

While large companies can generate the details, the small manufacturers are reluctant to generate safety information. This is where the National Medicinal Plant Board must make it mandatory to ensure that record of the herbs used and its source must be maintained, said Pani.

With regard to the submission of the details on the raw materials by the herbal formulators, Karnataka's 120 out of 167 ASU units are ready for submission before the due date of June 30, 2009. For the remaining 47 units, KIMMA will make efforts to help them submit the required details by July 31. By August 1, all the 167 units would submit record on the raw materials, said Pani.

The state is always known for its adherence to good manufacturing practices which in fact begins with sourcing of quality herbs, stated Dr B N Prakash, director, Karnataka Directorate of Ayush.