Home » Research » Formulating a Herbal Drug

All herbal formulations at Himalaya find their roots in classical Ayurvedic texts. A team of botanists and Ayurveda experts at our R&D center review these scholarly texts and shortlist suitable herbs for further research. The availability and sustainability of these herbs are first ensured before research is initiated.

Himalaya's phytochemistry team studies the geographical and seasonal variations of marker profile of these herbs. Active markers within these herbs, which are responsible for its therapeutic property, may vary depending on whether they are cultivated or sourced from the wild. Phytochemical profiling is established from different seasons and geographical locations to ensure batch-to-batch consistency, good quality and standardization. The quality of herbs is further maintained either by cultivating herbs under supervision of agricultural scientists or by practicing sustainable collection and harvesting practices under the supervision of trained botanists (in case of herbs sourced from the wild). Herbs have to further pass through stringent quality checks as per internal specifications laid out by our scientists.

With a focus on taking herbal research to new levels, Himalaya's scientists have adopted bioassay guided fractionation and purification technology to identify the active fractions. This ensures that the herbal preparation is standardized and formulation has required levels of bioactive compounds to elicit the pharmacological response. This technology will continue to help in identifying phytoactive principles responsible for efficacy, synergy and bioavailability. Himalaya’s scientists are leveraging this technology for innovative treatments of ailments including cancer, diabetes and depression as well as for specialized products in skin, oral and hair care categories.

Super Critical Fluid (SCF) extraction is one of the fast growing technologies for extracting herbal materials without using chemical solvents. Himalaya’s scientists are leveraging this technology during research and development for the extraction of beneficial bioactive compounds. This ensures no solvent residues in herbal preparation while delivering to the safety and efficacy of the products.

Extracts from single herb or a combination of herbs are initially tested on disease models of cell lines to evaluate the efficacy of the drug. Once efficacy is confirmed, these extracts undergo rigorous toxicity tests and mutagen studies to ensure that it is safe to test on humans. The extracts are formulated into the desired dosage forms (capsules, tablets, etc) and then enter human clinical trials. All clinical trials follow Indian and international norms on human subject testing.

Once safety of the drug has been established, it goes through three phases. The numbers of patients increase in each phase before the drug is launched into the market. In Phase 1, the drug is administered to a small number of healthy human subjects to assess safety of the formulation. Both Phase II and Phase III studies are conducted to assess the true efficacy in patients suffering from the disease. These studies are undertaken in leading hospitals and institutes across the world.

We have conducted clinical trials for our products in leading hospitals in India and worldwide including the All India Institute of Medical Sciences (Delhi), Apollo Hospitals (Chennai), St. John's Hospital (Bangalore), IMS BHU (Varanasi), Mayo Clinic (Rochester, New York), the Central Institute of Tuberculosis of The Medical Academy of R.F., (Moscow, Russia), The Novosibirsk Research TB Institute (Russia), and Charles University (Prague). Himalaya has over 1,200 published clinical trials in leading international journals including Journal of the American Medical Association (JAMA), Alternative Medicine, Indian Journal of Pharmaceutical Sciences, The British Journal of Radiology and Journal of Ethnopharmacology.

Phase IV studies are also conducted by Himalaya, which involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.