AYURVEDIC FORMULARY OF INDIA AND AYURVEDIC DRUG INDUSTRY

Dr.Amritpal Singh, Herbal Consultant, Mohali

Professor Ish Sharma, Ayurveda Chair, Faculty of Medicine and Health Sciences, University of Mauritius

Introduction

Formulary is a list of preion drugs covered by a preion drug plan or another insurance plan offering preion drug benefits. Formulary is also known as a drug list. 

The first part of Ayurvedic formulary of India (AFI) was published in the year of 1978 by Government of India, Ministry of Health and Family Welfare, Department of Health, New Delhi covering 444 formulations. The chief mandate of the publication was to collect the scattered information on classical Ayurvedic formulations and present the data in a schematic way, keeping in the mind the requirement of the pharmaceutical industry. The second part of Ayurvedic formulary of India describes 191 classical formulations.  The first edition of the third part of Ayurvedic formulary of India has included deion on 350 classical formulations.

Classical formulations in Ayurveda

The classical Ayurvedic formulations are also addressed as Ayurvedic compound formulations. These are broadly classified into two distinct groups viz. 

(1) Kasthausadhi (predominantly plant drugs) and 

(2) Rasausadhi (predominantly metals and minerals).

There are about 21 varieties (Asava and Arista, Arka, Avaleha and Paka, Kwatha, Churna, Guggulu, Ghrita, Churna, Taila, Dravaka, Lavana, Kshara, Lepa, Vati and Gutika, Varti, Netrabindu and Anjana, Sattva, Kupipakva Rasayana, Parpati, Pishti, Bhasma, Mandura, Rasayoga and Lauha) of compound formulations in which some of the single drugs of animal origin (52 in numbers); mineral origin (55 in numbers) and plant origin (351 in numbers) are used. 

For the manufacturing of the classical Ayurvedic formulations, a company need to take an appropriate license. The name of the classical Ayurvedic formulation and reference has to be specified on the label of the bottle. It is the sole discretion of the company to mention the complete formula on the label. Some companies mention 'Classical' Ayurvedic Formulation on the label. 

The classical Ayurvedic formulations can be polyherbal, polymineral and herbo-mineral. Polyherbal formulations form nucleus of the Ayurvedic pharmacy. Polyherbal preparations like Triphala, Trikatu and Rasna Panchaka have shown promising result in pharmacological screening. Trikatu increases bioavailability of other drugs and this can be described as frequent use of Trikatu or its ingredients in formulations in Ayurveda. Triphala has been demonstrated to have anticancer effect.

Ayurvedic formulary of India and drug industry

It is vital for the industry to follow the standards laid down in the formularies and pharmacopoeias to meet the requirements of the domestic and international markets. In Ayurvedic medicine, an array of poly-herbal, herbo-mineral and poly-mineral formulations have been mentioned. Certain formulations contain poisonous ingredients and Ayurvedic formulary of India has clearly mentioned methods of purification before application in the making of formulations. 

An Ayurvedic formulary of India is an integral part of the libraries of Ayurvedic colleges and manufacturing houses. The introductory study of Ayurvedic formulary of India is part and parcel of the Ayurvedacharya (B.A.M.S) syllabus. The detailed study is included in the syllabus of postgraduate subjects like Dravyaguna and Rasa Shastra. 

Just as the knowledge of the norms of the Drugs and Cosmetic Act applicable to Ayurvedic drugs is mandatory for running Ayurvedic drug industry, an Ayurvedic formulary of India is also essential. The essential list for Ayurvedic drugs published by Government of India, Ministry of Health and Family Welfare, Department of Health, New Delhi is also correlated to Ayurvedic formulary of India.

Role of Ayurvedic formulary of India in drug standardization

Standardization of any herbal formulation is essential in order to assess the quality, purity, safety, and efficacy of drugs based on the analysis of their active properties. Testing of Ayurvedic preparations using scientific methodologies will add to quality and authenticity of the product. Recent work on standardization of Ajmodadi churna, Bhunimbadi Kvatha churna, Malaksadi taila, Hutabhugadi churna, Rajanyādi churna, Sulaharan Yoga, Shadbindu Taila, Sitopaladi churna, Panchagavya Ghrita and Draksharishta and estimation of sterols from Dashmulakwatha is based on the information of preparation of these formulations in Ayurvedic formulary of India.

Formulary of Ayurvedic Medicines of Central Government Health Scheme

The formulary of the Ayurvedic Medicines of Central Government Health Scheme (CGHS) includes

• Generic medicines procured through Indian medicine Pharmaceutical Corporation Limited (A Government of India Enterprise). It includes 153 formulations. 
• Ayurvedic Generic Medicines procured through Tender Process. It includes 38 formulations. 
• Ayurvedic Branded Medicines. It includes 56 formulations. 

Future amendments

During these last years, a significant data has accumulated as far as chemical constituents and standardization of Ayurvedic formulations is concerned. Ayurvedic formulary of India provides vital clues for carrying out investigative work on the classical Ayurvedic formulations. This century several phytochemical and pharmacological investigations have been carried out on the classical Ayurvedic formulations. Several markers have been reported in classical Ayurvedic formulations providing a platform for chemical standardisation. 

Further, upcoming editions or issues of Ayurvedic formulary of India should incorporate information on non-clinical, clinical and toxicological investigations. The recent issues of Ayurvedic pharmacopoeia of India have published fingerprint studies on single herbal drugs. Similar data on classical Ayurvedic formulations (TLC, HPLC, and HPTLC) should be provided in the forthcoming editions of Ayurvedic formulary of India so as to increase the practical utility of the same. 

Role of Central Council of Research in Ayurvedic Sciences in amending Ayurvedic formulary of India

Ayurvedic formulary of India should not only be restricted to classical Ayurvedic formulations. It should include data on novel formulations developed by Central Council of Research in Ayurvedic Sciences. The Central Council of Ayurveda & Siddha developed a formulation, which has been found to be very effective in the safe treatment of malaria. It has been named as Ayush-64. It is claimed to have preventive and curative role in the treatment of malaria. 

Nava Jeevan, a formulation developed by Central Council of Research in Ayurvedic Sciences for the treatment of cancer. QOL has been yet another formulation for boosting immunity in cancer patients. AYUSH-SG has been developed by Central Council of Research in Ayurvedic Sciences for the treatment of rheumatoid arthritis. Similarly, AYUSH-82 has been developed for the treatment of diabetes mellitus and the process of commercialization of AYUSH-82 through the National Research Development Corporation (NRDC), New Delhi.

Work on these formulations developed by Central Council of Research in Ayurvedic Sciences should be incorporated in the Ayurvedic formulary of India for increasing its practical utility. It is also advocated that non-clinical data on coded polyherbal formulations should be incorporated in the forthcoming issues or editions of the Ayurvedic formulary of India to make it popular among non-Ayurvedic fraternity. 

Conclusion

The Ayurvedic pharmacopoeia of India, an Ayurvedic formulary of India, Pharmacopeial Standards for Ayurvedic formulations, Legal Status of AYUSH drugs and Essential Drug List are some fundamental and significant publications by the Government of India, Ministry of Health and Family Welfare, Department of Health, New Delhi. Continuous updating of data is the real need of the hour so as to facilitate the Ayurvedic drug industry. 

 

 

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