Ayurveda Drug Manufacturers Association (ADMA) and Karnataka Indian Medicine Manufacturers Association (KIMMA) have apprised the European Ayurveda Association (EAA) on the limitations of herbal drug parameters as compared to the chemical formulations.
The discussions have been on for the last one year and the EAA have expressed total support for the marketing of Indian herbal drugs in the European Union, JSD Pani, president, KIMMA told Pharmabiz.
The need for such intense discussions came about as a ban on Indian herbal medicines is looming large. The EAA officials who are here in India expressed total support for Indian herbal products and had also assured ADMA and KIMMA that necessary efforts would be made to prove to the European Union regulatory team who have developed the Traditional Herbal Medicine Product Directive (THMPD), he added.
According to Pani, despite the EU herbal drug order to ban Indian System of Medicines in the region with effect from March 2011 which came up during the recent WTO Brussels meet, there was every likelihood that the move may be reversed.
"Therefore we are confident that Indian drugs cannot be completely banned. The new herbal drugs getting into the market are being developed to prove the contents. The government of India has also imposed stringent rules on quality control and mandated Schedule T compliance for production. There are quality tests labs identified across the country for this purpose. Indian herbal drug manufacturers are now focused on the development and providing proof of quality and efficacy of the drugs," said Pani.
Even if it becomes difficult to prove the quality of the herbs in a combination, the local applications like balms and oils can get through. In fact these products are much sought after in EU because of the cold weather conditions, he said.
According Shashank Sandu, director, Sandu Pharma, this THMPD by EU is a typical white collared racism which will cut off trading ties with European Union. "The trade barrier will make it next to impossible for us to enter. However ADMA which has a pan India presence has made its submissions to the Department of Ayush who has been sensitive and sympathetic to the issue," he said.
In 2003, World Health Organization had issued guidelines for the Regulations of Herbal Medicines in South East Region which helps to accelerate the establishment of appropriate mechanisms for registration and regulation of herbal medicines within the region, based on criteria for safety of use, therapeutic efficacy, quality control and pharmacovigilance.
What EU fears from India is the less content of herbs, failure of dissolution tests, stability of products and presence of adulterants. There is also the use of indigenous herbal medicines and modified herbal drug preparations where dosage form, preparation and medicinal indications could vary, said industry sources.
India so long lacked the guidelines for herbal drugs. Now with the National Medicinal Plants Board (NMPB), Department of Ayush, in collaboration with the World Health Organisation (WHO)'s Country office for India, has issued a comprehensive guideline on Good Field Collection Practices (GFCP) for India. Another development is the 'Ayush' mark certification to reinstate the quality standard approved by the Quality Council of India, said industry sources. .
According to Dr. DBA Narayana, eminent scientist, the non tariff trade needs to be resolved in a proper and logical manner by mutual discussions. In fact,European Union would benefit if they recognized the time-tested traditional medicines and healthcare systems of India, he added.