Putting an end to the long debates on the scientific data of herbal medicines from India, the European Directorate for the Quality of Medicines (EDQM) - the key European Organisation involved in regulation and quality control of medicines is considering adoption of some of the Indian herbal monographs to the European Pharmacopoeia (EP).
The directorate is planning to tighten the links with the India Pharmacopoeia Commission (IPC) to select a list of herbals from traditional medicines on which the EDQM can work on. The availability of the product in Europe, extend of use of the particular product in the member countries and the non toxic nature of the traditional medicine would be the criteria to select the list of herbals, informed EDQM officials.
With 36 member states in the region, EDQM has in principle agreed adoption of selected Chinese and Indian traditional medicines into EP. The directorate has already adopted 15 herbal medicines from Chinese Pharmacopoeia (CP) in the last more than one year. Though it prepared a list of 100 herbal medicines for adoption, the authority later short listed 50 herbal medicines from China and the adoptions are expected to complete in next four to five years.
"We have started projects early for China because we have good contacts with them and China has been working as an observer for us for 15 years," Dr Claude Coune, head of publications and multimedia department, EDQM told Pharmabiz. "We put together a group specially dedicated to Chinese herbals. For the moment, there is no such group of experts for Indian herbals. We also have to tighten the links with India and Indian Pharmacopoeia. So we hope that during the course of next year we may know more about it," he added.
With this, the directorate intends to have better control over the herbal products to avoid toxic plant products and to make sure that herbals used in Europe are of good quality without large level heavy metal content and contamination of the products by insects. At present, there is no safety control over the herbal products which are sold mainly through shops other than pharmacies, he added.
The development comes as one of the fresh efforts from much regulated countries, even as the drug standards and regulatory authorities from United States and Britain have already showed their interest to include Indian natural products monograph in their pharmacopoeia, said Dr D B A Narayana, Head - Herbal Research, Hindustan Lever Research Centre, Unilever Research India.
"We should consider this as the first step from Europe and it means that there is a chance of recognition for Indian herbal products in the European Union. At least the quality parameters will be scientifically approved by the western countries and the drug regulator in the region will be confident about the products in due course," he enthused.
However, he added that the IPC should take steps against the adopting countries putting more stringent specifications or adding misinformation in the monographs in the adoption process, which may create technical barriers later. "Let us sign a clear memorandum of understanding between the countries to specify what should and should not be done on the monographs in adoption," said Narayana, who is also the Chairman of 'Crude Drugs and Herbal Committee' set by IPC.
The IPC efforts has resulted in inclusion of 32 more new herbal products monograph in the 2007 edition of Indian Pharmacopoeia. The committee has also taken various policy decisions to scientifically support the useful and user-friendly natural products, said officials.