Union government is expected to roll out regulations on phyto-pharmaceuticals and guidelines for nutraceuticals and ayurceuticals in a few weeks from now.
In the emerging situation, the new regulations will help to give an impetus to the herbal industry. Further, good scientific studies are the need of the hour to drive such initiatives, Dr DBA Narayana, an expert in pharmaceuticals and herbal sciences, told Pharmabiz.
Going forward, if a company wants to introduce botanical drugs or phyto- pharmaceuticals, regulatory authorities will mandate detailed data submissions in phyto- pharmaceuticals, nutraceuticals and ayurceuticals driven by the new guidelines. Currently, Indian herbal industry produces a number of standardized extracts like aqueous extracts, super critical fluid extracts, among others. These may not offer innovative products.
Industry will need to work on the need for differentiation. The demand for an economical, energy efficient, stable, safer solutions with better efficacy will need to be innovated. Innovative process in Ayurveda like Ksheera pak process which is cooking herbs with milk is prescribed for certain products in place of aqueous extracts. Taila Pak Vidhi which is cooking with oil and Bhavana process like co-extraction done with infusion of fresh juice or weak decoction of herbs instead of water will need to be researched further, he added.
Innovations in measurement sciences, like analytical fingerprinting technology would be the future of herbal extracts, he added.
So far industry adopts analytical methods called as fingerprinting for quality controls. However, experts recommended newer ways of finger printing which is an innovation in measurement science, giving batch-to-batch consistency. When one adopts traditional processes for herbal extracts, their history of safe use will provide potentials for no need for new safety studies. Safety/ Toxicological studies for herbals are difficult-to-do with the complexity of multi component herbs, such studies are time consuming, and expensive. Therefore, wherever, there are changes in process of extraction, the extrapolation of the history of use is not possible nor scientific. In such cases analytical scientists need to innovate.
Normally pharmaceutical analysis scientists normally look for quality just like exact standards possible to be tested in a synthetic molecule. But in the case of herbs, the emerging thought is to evaluate and ensure similarity and dissimilarity between materials of process of history of use and the new/modified technology. To study this, all measurement techniques like UV, IR, HPTLC, HPLC, EPLC, and NMR can be adopted. Such a data will provide a large number of data points. Researchers could statistically analyze such data points, adopting a process called “principal component analysis technology”. Such analysis will help in deciding the extrapolatability of the HoSU data and avoid detailed safety studies. This approach is becoming more widespread for natural products, said Dr Narayana.
Such newer analytical fingerprinting is useful for recognition and to assist identification but cannot replace a detailed characterization. The technique should provide signals for as many individual components as possible. When used correctly and in conjunction with the raw data, it could help scientists to summarize any variations in the herbal extracts. It should be adopted whenever a new process other than traditional processes, is used. But for routine quality control a simple single methods of analysis like TLC or HPLC profile is preferred, he stated.