Although the formation of Central Drugs Authority of India is viewed as a revolutionary change in the Indian System of Medicines in the country, the Karnataka Indian Medicine Manufacturers Association has called for a separate raw material processing law for Ayurveda, Siddha and Unani.

The proposal for separate divisions for Indian System of Medicine and Traditional system of Medicine among the 10 other divisions in CDAI provides the much-needed confidence among the small and tiny ISM drug producers, stated JSD Pani, secretary, Karnataka Indian Medicine Manufacturers Association (KIMMA). However, there is a need for separate drug approval norms for Ayurveda, Siddha and Unani manufacturers.

According to Pani, "It is not the plant or its herbs which are referred as a "System of Medicine' but the process of drugs manufactures and the use of such medicines in the treatment of an ailment which is known as a "System'. Similarly spices and fruits used in ISM drug manufacture are not medicines, instead the methodology adopted to process will depend on the drug development and the treatment thereafter."

Under classical texts approved under the Drugs & Cosmetics Act 1940 Schedule I, herbal plants, spices, fruits and metals when processed according to prescribed formats can be called as Indian System of Medicines (Ayurveda, Siddha, Unani).

Giving an example of Amalaki (gooseberry), the KIMMA secretary said, that it if it was processed for ayurveda drugs then siddha and unani specialists could not prescribe it. The mention of amalaki for use of ISM in the classical tests permitted by Drugs and Cosmetics Act classical texts is erroneous.

Therefore KIMMA recommends to the Union government that it should adopt the latest scientific processes in each of the different branches of ISM instead of following the prescribed classical texts blindly, which is harmful. It is high time that the Government through CDAI should evolve a strategy to encourage the separation of the ISM branches Ayurveda, Siddha and Unani in drug approvals.

Another grouse of the KIMMA is the exports of herbal extracts, which is being isolated by the global herbal drug majors to come out with novel molecules. This is affecting the purity of the ISM drug sector. A similar situation is repeated for Food Supplements, which are crude drugs.

According to director general of commercial intelligence and statistics India's export of Ayurveda, Siddha, Unani and Homoeopathy Medicines, crude plants and plant extracts in 2004-2005 is around Rs.1,595 crore.

With the increasing importance of traditional and alternative medicine in health care, the CDAI should recognize the safety and efficacy as well as quality control of traditional medicine, which are serious concerns, addressed by the regulatory authorities of the Department of AYUSH.