The Ayurvedic Medicine Manufacturer's Organisation of India (AMMOI) has urged the Union health ministry and the department of Ayush to modify the draft rules of clinical trials made for the approval of ayurvedic drug formulations, by incorporating suggestions from the industry. In the rules, the department has suggested that every manufacturing company should follow the norms of Good Laboratory Practices and Good Clinical Practices besides complying Good Agricultural Practices for bringing up raw materials.

The ayurvedic experts and other representatives from ISM sector had deliberated on the proposed rules at a workshop conducted by the Organisation as part of the Arogya 2009 Fair held in Thrissur in Kerala last week. The fair was jointly organized by the State Government, Department of Ayush, Oushadhi and Ayurvedic Medicine Manufacturer's Organisation of India.

The participants while agreeing in general for better regulations in the matter of approval of drugs, observed that the classical ayurvedic drugs formulations whether containing Schedule E1 drugs or otherwise were time proven drugs and their safety and efficacy were well documented in authentic texts. They remarked that in the case of proprietary drug formulations, which are also processed out of ingredients specified in the authenticated texts, the safety and efficacy are well proven. So requirement of clinical trials and published literature maybe insisted for new indications or individually processed combination drugs only (proprietary medicines).

While agreeing the principle that medical advice and supervision are required for use of any drug for long period over three months, the AMMOI has said what is actually needed is a cautionary note or warning on the labels and not fresh evidence of safety and efficacy. They observed that under the existing law, use of new drug was not possible and hence requirement of profiles in the form of safety and efficacy data were not required for the above categories of drugs including aqueous extracts. In the case of solvent extracts, it would be appropriate if the Ayush department published acceptable safety parameters to be adopted by all instead of insisting individual manufacturers to follow them.

While speaking to Pharmabiz, general secretary of AMMOI Dr Ramanathan said even when there is necessity for studying the safety and efficacy profiles of combinations of hazardous ingredients, the matter needs further study before any move to bring a regulation is contemplated. He said the majority of the ISM companies have no sufficient infrastructure facilities required for conducting the clinical trials. He added that for tablets and capsules, for which the Ayush department has already prescribed the additives permissible, processed out of dried aqueous extracts, no fresh safety profiles or published literature was required other than the rationale of the dosage. A decision on this could be taken by the licensing authority along with their statutory expert committee.

As a recommendation for amendment of the draft rules, the organisation has suggested that the restrictions and regulations proposed in the case of drugs other than those containing hazardous ingredients may be dropped, and the measures required in the case of hazardous formulations may be deferred for the time being. A decision on this must be taken after a detailed interaction with all stakeholders.

Earlier the department had issued a directive to the ISM industry that the herbal medicines manufactured in the country should be tested for the presence of heavy metals such as arsenic, lead, mercury and cadmium and ensured that they contained those metals only below the permissible levels, before they were exported.