Abstract

LEGAL ASPECTS OF AYURVEDA DRUG MANUFACTURING

Reetesh Ramnani*, Amit Kumar Sharma, Mukesh Chaudhari, Amit Mishra and K. Shankar Rao

ABSTRACT

The word Legal is used to describe things that relate to the law or an action or situation that is Legal and is allowed or required by law and Aspect means Appearance, Factor, Part, Peculiar feature, Regard, Perspective etc.[1] The Aushadha/Dravya (Drug) has been considered as 2nd most major factor of chikitsa chatushpada (Four limbs of treatment) as Acharya Charaka described the qualities of drug 1) Bahuta (Abundance) 2) Yogyatvam (Applicability) 3) Anek-vidhkalpana (Utility in various forms) 4) Sampannata (Wholesome). Herbals, herbo-minerals and herbo-metallic are main preparations in Ayurveda offering remedies to various illnesses. Safety of these preparations remained the point of concern to policy makers, aware prescribers and informed consumers alike.[2] An exercise to make Ayurvedic drugs hassle free essentially begins with their manufacturing. Beginning from the procurement of raw material till its final disposal, every step is equally important to ensure the safety & efficacy of these drugs. The main objectives of GMP are 1) Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination. 2) The manufacturing process is as has been prescribed to maintain the standards. 3) Adequate quality control measures are adopted. 4) The manufactured drug which is released for sale is of acceptable quality. To achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacturing of drugs which should be documented as a manual and kept for reference and inspection. In this regard the concept of Paribhasha, Manaparibhasha, Pratinidhi Dravya, Anukta Dravya grahana, Dravya sangrahan kala, Anupana, Aoushadha sevana kala, with Ayurvedic perspective in drug manufacturing is also important one. Ayurvedic formulary consists of over thousands of identifiable plant products which are regularly used in the form of medicine. Indian government issued GMP and GACP guidelines for preparing Ayurvedic formulations in 2003 issued by the dept of AYUSH and GCP guideline is also issued in 2003 by Central Drug Standard Control Organization (CDSCO), in India. These guidelines are invariably concerned with drug trials leading to research and not to the clinical practice in general. Conclusion: So following the GACP, GMP & GCP guideline in Ayurvedic drug manufacturing along with many basic important intricacies which are exclusively intrinsic to Ayurveda are really helpful to prepare quality Ayurvedic formulation with maximum safety and efficacy.

Keywords: GMP, GCP, GACP.