Traditional systems of medicine based on herbal sources have contributed to welfare of human society from time immemorial. However, due to their diverse range and complexity it was a challenge to establish quality control standards as in the case of allopathic medicines.
Department of AYUSH (Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homeopathy)under Ministry of Health & Family Welfare, Govt of India has made significant contributions in this direction leading to:
- Delivery of Quality AYUSH healthcare services
- Quality education and training to AYUSH doctors and scientists
- Propagation and popularization of AYUSH as an alternate system of medicine in India and abroad
- Pharmacopoeial standardization of AYUSH drugs
- Minimum standard regulation notifications on Ayurveda,Siddha,Unani and Homeopathic systems
- Good Clinical Practices(GCP)guidelines in Ayurveda,Siddha and Unani medicines
WHO in collaboration with AYUSH is establishing protocols or monographs for the world wide acceptance of traditional plant medicines. Continuous efforts of APC (Ayurvedic Pharmacopeia Committee) & PLIM (Pharmacopoeial Laboratory for Indian Medicines) have resulted in publication of several monographs .
Standardization of drugs confirms identity, determination of quality, purity and detection of adulteration by various parameters. It also maintains consistency of claimed efficacy of the product and its batch to batch reproducibility.
Herbal drugs and formulations can be standardized for chemical efficacy, physicochemical and pharmacological parameters to validate the whole manufacturing process.
WHO stresses the importance of the qualitative and quantitative characterization and has set specific guidelines for the assessment of safety, efficacy and quality of herbal drugs covering :
- Quality control of crude drug material, plant preparations and finished products.
- Stability assessment and shelf life.
- Safety assessment documentation based on experience or toxicological studies.
- Assessment of efficacy and biological activity
Techniques currently involved in standardization of crude drugs:
Macroscopic Methods includes identification of herbs based on shape,size,color,texture,fracture and appearance
Microscopic methods include identification of powder material on the basis of treatment with chemical reagents and analysis of their special characteristics.
Physical Methods include viscosity, melting point, solubility, moisture content, volatile matter, specific gravity, density, optical rotation, refractive index, bitterness value, hemolytic activity, swelling index, foaming index, ash value&extractable via hot extraction or cold maceration
Chemical methods include various chemical tests and assays such as acid value, saponification value, peroxide value, etc.
Biological methods include the estimation of crude drugs or preparations on living organisms like bacteria, fungi or animal tissue called BIOASSAY.
Analytical methods include both qualitative and quantitative estimations.The bioactive extract is standardized on the basis of chromatographic fingerprints using TLC.HPTLC, HPLC and GC.
In the coming time collaboration between national and international bodies will result in evolution of a universally acceptable standards code .This global effort will go a long way in making life easy for manufacturers who still do not have documented standards to this day for some products and make herbal medicines accepted in households across the world.
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About the Author:
Mahima Agarwal is a pharma professional specializing in Pharmacognosy. After her postgraduation from Rameesh Institute, Greater NOIDA, India she is working with Arbro Pharmaceuticals, New Delhi for last 2.5 years. Mahima has rich exposure to analysis and standardization of herbal medicines and health supplements.