The Central Government will soon bring in more control and vigil on manufacturing and marketing of ayurveda, siddha and unani (ASU) drugs to ensure their safety and quality standards including a move to curb irrational ASU combinations.

Talking to Pharmabiz on the sidelines of an interactive meeting of exporters and officials organised by Pharmexcil in Mumbai, Dr. S.K. Sharma, advisor, ayurveda, said, "Certain guidelines have been issued to various state licensing authorities to curb the increasing number of irrational ASU combinations floating in the market. The government is in the process of identifying such combinations, mainly licensed as patent and proprietary medicines by various states. Similar sounding brands are also causing confusion in the market."

As reported earlier, the Department of AYUSH in consultation with the related stakeholders will come out with more detailed guidelines for licensing of classical and patent and proprietary ASU medicines based on a product dossier system to strengthen the licensing framework for ASU drugs.

"Though our classical formulations are time tested for more than 3000 years, the P&P medicines are mainly innovations. There is a need to control unnecessary licensing of such medicines. These kinds of medicines are responsible for most of the issues which tarnish the image of Ayurveda in India and abroad," Sharma said.

The Department has initiated many measures recently to stringently regulate the sector. Lack of adequate manpower with various states is an issue in enforcing the rules. Almost five years were given for units to comply with the rules on Schedule T, as it was notified in June, 2000. In October 2005, the state governments had been asked to ensure strict compliance of GMP by ASU drugs manufactures and cancel the license of non-GMP compliant units. Three extraordinary circulars were issued in October 2005.

One was on proper labelling, packing and conspicuous display of all the ingredients along with the quantities contained in the formulations on the label/container or a leaflet inserted inside the container. Mandatory testing for heavy metals on purely herbal ASU drugs will be extended for sale of purely herbal ASU drugs within the country in phases keeping in view the testing infrastructure within the country. Use of permissible excipient, preservatives for increasing the shelf-life of ASU drugs has been notified and the draft rules for expiry date of ASU drugs have also been published in November, 2005 and a consultation process is on for finalising these rules.