Experts have called for good clinical practices (GCP) and stronger regulatory mechanism to establish the safety and efficacy of botanical drugs and ensure wider acceptance to them at the emerging global market.

Taking part at a two-day ‘Indo-US Symposium on Botanical Drug Development’ held near here recently, the experts from both India and abroad also felt that at present the sector was confronting multiple challenges in establishing the safety and efficacy of the herbal drugs.

Addressing the symposium, eminent pharmacologist Dr Y K Gupta said even the very question 'whether we need randomized clinical trials for such age-old medicines' was a debatable issue. However, he said there is a need for GCP to harmonise evidences with modern medicines, establish credibility in the global village and promote holistic medicines.

Lack of uniform standards, limited and scattered clinical data, absence of structured pharmacovigilance, inadequate regulatory control, and lack of specific research methodology were among the challenges for herbal drugs, he said, while noting that India could not produce yet a block buster ASU (Ayurveda, Siddha, Unani) drug at the global turf yet.

Veteran expert in the field of pharmaceuticals Prof Ranjit Roy Choudhury also pointed out that at present there were not enough guidelines and practices for establishing the credibility of botanical drugs.

The symposium was jointly organized by CSIR-Indian Institute of Integrative Medicine, Jammu, Medanta – the Medicity, Gurgaon and National Centre for Natural Products Research (NCNPR), the University of Mississippi, USA

In his inaugural address, former ICMR director general Prof. N K Ganguly said that the botanical/ herbal drugs were emerging as mega business world over as their importance had been universally acknowledged.

Dr G N Qazi, vice-chancellor of Jamia Hamdard University, said that the increasing demand for botanical drugs had to be supported with authentication and standardization based on molecular and chemical markers, as well as ‘chemistry manufacturing and control (CMC), bio-efficacy, and preclinical safety/toxicity studies using modern scientific knowledge and analytical tools. He also advocated for the need to harmonize Indian pharmacopoeias with other International Pharmacopoeias to the extent necessary.

Prof Larry Walker, director of NCNPR, pointed out that various regulatory bodies across the globe including US FDA had created regulatory pathway for the clinical trials and approvals of herbal drugs, sensing the need for integrating them with mainstream treatment.

Dr Naresh Trehan, chairman-managing director of Medanta, said his hospital was already working with CSIR-IIIM, Jammu for developing a natural pure chemical entity for solid tumours and a single herb extract to overcome thrombocytopenia.

Dr Ram Vishwakarma, director CSIR-IIIM, Jammu, Prof Ikhlas Khan from NCNPR, USA, Jitendra Sharma, CEO of National Medicinal Plants Board,  Dr U V Mallavadhani from IICT Hyderabad, Rama Jayasunder, additional professor, Department of NMR, AIIMS, Dr Ramesh Mullangi, director and associate vice president-DMPK, Jubilant Biosys, Bangalore, Prof Saranjit of NIPER, Mohali, Ranjit Anand Puranik, CEO of Shree Dhootapapeshwar Limited, Mumbai, Dr G Geetha Krishnan, head of Integrative Medicine Department, Medanta, Dr P Ram Manohar, director and chief scientific officer, AVP Research Foundation, Coimbatore, Dr Rajesh Kotecha, vice-chancellor, Gujarat Ayurved University, Jamnagar, Dr Ashok Kumar Vaid, Dr Richard L Summers, professor of Emergency Medicine at the University of Mississippi Medical School and director of Emergency Medicine Research, and Dr Srinivasan Vijayakumar, professor and chair radiation oncology, interim director, UMMC Cancer Institute, Mississippi, USA, were among those who addressed the symposium.