Union government's intention to have clinically tested Ayurveda drugs will not only provide large global market opportunities but also spur growth prospects for the clinical research organisations (CROs). At the same time it will pose as a huge financial burden for the micro, small and medium enterprises (MSMEs).

Empirical research and clinical trials only would ensure quality, safety and efficacy of herbal and plant medicines. It will build credibility of Ayurveda drugs since it will scientifically prove the therapeutic benefits. While Ayurveda is gaining acceptance globally, there are concerns over the quality. If the clinical trials are mandated then just like the pharmaceutical sector, Ayurveda industry will also need to approach CROs. This in-turn provide ample scope for additional growth of the CRO industry, Dr Pralhad Patki, head - medical services & clinical trials - R&D, The Himalaya Drug Company told Pharmabiz.

There are already a number of human studies carried out by international herbal companies. As far as Himalaya is concerned, it is 'business as usual'. It has a full-fledged medical services and clinical trial department. Regulations that push the industry to adopt better practices ultimately benefit patients. "We are already conducting clinical trials for every product and will continue to do studies at leading hospitals, publish trial results in renowned national and international medical and peer-review journals. In fact, Himalaya too has some of its trials being planned overseas," he added.

Clinical trials for Ayush sector are welcome because its credibility needs to be proved with relevant data and would provide a wider basket of offering to modern medicine physicians to prescribe Ayush drugs like Brahmi or Liv 52 as a good alternative or adjuvant therapy. There are no Hepatobiliary stimulants and Liv 52 is the first choice by allopathic doctors, said Dr Ramananda Nadig, dean Clinical Research Education Academy.

Although the mandate for Ayush drug clinical trials is still a draft notification, but the over 95 per cent MSMEs in this space are up in arms over the issue of carrying out human studies. This is because of the poor financial and human resources to drive the trial.

According to JSD Pani, president, Karnataka Indian Medicine Manufacturers Association, the time is not ripe for the government to announce this. Clinical trials cannot apply to herbal industry going by its poor financial muscle. From a government perspective, it needs to create an efficient process of approval with adequate infrastructure and qualified-experienced personnel.

If the government goes ahead to call for clinical trials for herbal drugs, it is a death knell of the small-medium industry as it makes no business sense. Instead, the call for human studies reports will allow unethical practises to prevail. It will be extremely difficult for the industry barring the large companies to afford a trial, pointed out Dr Chitra Phadnis, managing director, Madhu Pharma.

While there would be ample benefits if a herbal formulation undergoes clinical trials, the challenges are immense. It would be a major task to identify a clinical trial centre with access to subjects willing to be tested with herbal medicines and be able to deliver a good clinical protocol. Another issue is that government should ensure specific guidelines which are not cumbersome for fast-track approval. Moreover, adequate infrastructure should be put in place for inspection to expedite the process and avoid unnecessary delays, stated Dr Patki.

Since herbal drug trials are not high budget studies, the department of Ayush has been utilising the services of several small CROs to prove the efficacy and safety profile of drugs. Therefore MSME could approach small CROs which would be more affordable than the large ones, said Shekhar Gupta, chief operating officer, D2L Pharma Research Solutions.