The Central Drug Standard Control Organisation (CDSCO) may soon come out with a set of guidelines for evaluation of botanical drugs to be licensed as OTC drugs or prescription drugs in the country. The guidelines are intended to have a quality check on the herbal/OTC botanical drugs that are being imported into India.

The western herbs reaching the country will be adequately researched using research methodology of ISM and their characteristics evaluated on ISM parameters like Rasa, Guna, veerya, vipaka, prabhava etc before adoption of such products in ISM system could be permitted.
The expert committee under the chairmanship of Dr R A Mashelkar that is currently looking into the possibilities of improving drug regulatory system in the country is known to have had extensive deliberations on the need to bring in such a system to have a check on drugs of natural origin that are entering Indian market. The committee is likely to recommend the constitution of a high level ISM expert committee to critically evaluate the same and identify the process to be adopted for this purpose.

The Drugs and Cosmetics Act currently provides detailed guidelines for approval of drugs and cosmetics not so far approved for marketing in the country and also grant of import permissions/approvals for such drugs. However there are no clear provisions in the existing rules pertaining to import and marketing of herbal products and cosmetics from other countries. Interestingly, several countries require registration of herbal and cosmetic products before they can be marketed in those markets. Drug regulatory agencies like US FDA and Australian TGA already have such guidelines in place for evaluating botanical drugs of foreign origin.

It is known that the Mashelkar committee may suggest the inclusion of such herbal drugs also under the "new" drug definiton in rule 122 E of Drugs & Cosmetics Act.