The Unani Pharmacopoeia of India - Part 1, Volume 1

Unani System of Medicine is based on the drugs originated from plants, animals and minerals. The system is as old as humanity. In recent years, there has been a renewed interest in the indigenous/traditional system of medicine in both developing and affluent countries of the world, particularly because of the fact that these drugs have no major side- effects and accelerate the immunity of body resistance unlike modem medicine. Furthermore, Unani, Ayurveda and Siddha drugs are time-tested, centuries old, safe for use and cost effective. However, there is a need to maintain their purity, quality and safety by subjecting the finished products to rigorous scientific testing and to lay down pharmacopoeial standards for both Single and Compound drugs to bring them within the purview of Drugs and Cosmetics Act, 1940, as amended in 1964. This necessitated the working out of the standards for each drug.

To fulfil the above objectives, The Government of India set up in 1964 the Pharmacopoeial Committee for Unani Medicine. Simultaneously, a Pharmacopoeial Laboratory of Indian Medicine was also established in the year 1970. This Laboratory was established mainly to work for evolving standards for Ayurveda, Unani and Siddha drugs. The Unani Pharmacopoeia Committee, as a result of extensive deliberations compiled a National Formulary of Unani Medicine containing 441 formulations and this was published by the Ministry of Health and Family Welfare in 1981.

The Government of India have all along been concerned with the quality of drugs in various Indian Systems of Medicine and consequently, the work in this direction was taken up by the Laboratory concerned. I am glad to say that it has now been possible to bring out the first volume of pharmacopoeial standards entitled "UNANI PHARMACOPOEIA OF INDIA( PART-I)". It comprises standards for 45 Single drugs of plant- origin included in the National Formulary, Part-I, and work on which has been carried out at Pharmacopoeial Laboratory, Ghaziabad. This would set pace for evolving standards in Unani Medicine and help researchers, pharmaceutical houses and Government of India to enforce Drug control measures on these drugs in order to maintain their quality, purity and safety for human consumption.

With the setting up of a separate Department of ISM & H, we have focussed our attention on accelerating the pace of this work and currently, the work of laying down pharmacopoeial standards for more than 5000 drugs of Indian System of Medicines (ISM), of both plant and animal origin is in full swing. Government of India have identified 29 drugs testing laboratories across the country to take-up the work on single and compound formulations during the Ninth Five Year Plan, and to publish the subsequent volumes providing data on pharmacopoeial standards for various drugs investigated.

I take this opportunity to express my sense of commendation to PUM, Ghaziabad and the experts of Unani Pharmacopoeia Committee, along with the technical and administrative staff of the Department for their valuable contribution and help in accomplishing this task.

I also wish to state here that Government of India, Ministry of Health and Family Welfare is fully aware of the fact that being a first effort of its kind in the field of Unani System, there may always be room for further review and improvement. The suggestions and advise from the experts and scientists of this fields will, therefore, be welcome and most valuable in bringing out subsequent improved editions.

Our country having a unique distinction of veriety of geographical and climatic condition and rich in Flora and fauna many of which are used in the preparation of poly pharmaceutical recipes of Unani Medicine and a few as home remedies in the country.

Unani system of Medicine has distinction of being a scientific system and its practitioners were innovative in therapeutics and carried out clinical trials out of the local flora from the countries it has passed through and discovered newer medicines and added to the classical literature.

During Colonical rule, the Unani system of Medicine got a set back as it was not patronised by the Government in power, was confined to the rural areas where it was protected and nurtured.

Urbanisation led to neglect of development and maintenance of forest and intern the availability of rich flora. Later because of better communication, transport and establishment of Agencies for supply of Crude drugs, let to commercial manufacturing of Unani drugs on mass scale and many factories were established. In this set up the Unani practitioners could no longer processes and prepare their own medicines, but started depending on Pharmaceutical houses run commercially and on supplier of the crude drugs to the extent they needed. There was no any governmental control on the manufacturer/ Pharmaceutical houses to ensure the quality of medicines marketed.

The Government of India constituted a committee under the Chairmanship of Lt. Col. R. N. Chopra in 1946, which had gone into the question of need for proper identification of plants used in Indian Systems of Medicine, control over collection and distribution of crude drugs and made positive recommendation for compilation of pharmacopoeias. After independence not only the Unani education, but also Unani drugs, there marketing and manufacturing was given a concrete shape.

In compliance with the recommendation of various committees constituted by Union Government, the CCRIMH was established in 1969 by the Government of India for Research in all aspects including Drug Standardisation in Indian Medicine and Homoeopathy. In 1978, this Council was divided into four research councils and the research work in Unani system of Medicine was entrusted to Central Council for Research in Unani Medicine.

The Pharmacopoeial Laboratory of Indian Medicine, Ghaziabad was established in 1970 for testing and standardisation of single drugs and compound formulations of Indian System of Medicine. Unfortunately till date there is no component for Unani System of Medicine at this laboratory. Inspite of repeated efforts by Unani Pharmacopoeia committee and individual Unani experts at various levels. The Central Council for Research in Unani Medicine have six survey units in different states and also established standardisation work of single and compound medicine at seven Drug Standardisation Research Units established by the Council.

The First Unani Pharmacopoeia Committee was constituted in 1964 under the Chairmanship of Col. Sir Ram Nath Chopra The Committee was reconstituted in 1968, 1977, 1988 under the Chairmanship of Dr. Hussain Zaheer, Dr. Md. Yusufuddin Ahmed and Dr. A.U. Azmi respectively under taking the work of Unani Pharmacopoeia of lndia.

After the publication of First part of the National Formulary of Unani Medicine consisting of 441 formulations, the second part of National Formulary of Unani Medicine consisting of 202 formulations was prepared and submitted to the Ministry for publication. The third part of Formulary is under publication process. In this processes, a list of single drugs which goes into the formulation emerged and the committee applied its minds to the task of collection of data from various sources such as PLIM / CCRUM where the experimental work has been carried out and data produced.

With the uniformity in the Educational pattern of Unani System of Medicine all over the country, the Government decided that there should be uniformity in the Unani Medicine marketed. In so far as their identity, strength and purity are concerned and to assure the quality of the medicine, through proper drug control measures. To serve the public and the profession, the Government has published National Formulary of Unani Medicine Part - I and the Unani Pharmacopoeia Committee has completed the Unani Pharmacopoeia of India, Part-I for better quality assurance.

The Government of India have brought the Unani drugs under the perview of the Drugs and Cosmetics Act 1940. The publication of the National Formulary of Unani Medicine and the Unani Pharmacopoeia of India Part - I could help the Government, a base for enforcement of the Act in respect of the standard.

The Unani Pharmacopoeia Committee has made a modest attempt to lay down norms of the single drugs, based on the experimental data worked out at PLIM, Ghaziabad and Drug Standardisation Research Units of Central Council for Research in Unani Medicine. The modem medicine in Western countries have also passed through this phase decades ago. The Unani Pharmacopoeia Committee has made a beginning in this direction with regard to compilation of the Unani Pharmacopoeia of India Part - I. The Unani Pharmacopoeia of India Vol. I comprises 45 monograph of single drugs of plant origin which are used in one or more formulations enlisted in the National Formulary of Unani Medicine, Part - I. In compiling the monographs the title of each drug has been given as in the Unani literature. The definition of the drug giving its identity is in scientific nomenclature and very brief information about its source, occurrence, distribution etc., has been given.

It is followed by the list of other names in Arabic, Persian and Urdu followed by Indian regional languages. The monograph records the detailed gross and Microscopic description of the drug and its Microscopic tissue structures etc., having a Pharmacognostic value in identification especially when the drug in powder form.

The monograph also gives the details of chemical constitutents physico-chemical standards and an assay, pH value, extractive valves and TLC behaviour of petroleum ether (60-80°) extract.

In the efforts to compile pharmacopoeial monographs of Unani drugs, the classical attributes of the drugs according to Unani system like action and therapeutic uses along with the dosage has been mentioned even though there is no specific established experimental method to quantify them is available for the time being.

The Legal Notices and General Notices have been included for the guidance of the analysts, manufacturers, research workers and pharmacies engaged in the field. Details about the equipments, reagents and solutions, tests, method of preparation of specimens for microscopical examination are given in appendices.

The Unani Pharmacopoeia Committee feels that with the publications of Unani Pharmacopoeia of India - Part - I comprising of 45 single drugs of herbal origin, the format and procedure has been laid down and their should not be any difficulty for the researchers and pharmaceutical houses to plant the research so that the out put of work could be accelerated.

The Unani Pharmacopoeia Committee request the Government of India to pass an Ordinance/Act for the adoption of the Unani Pharmacopoeia of India 1998 Volume I, and bring it under the perview of the Drug and Cosmetics Act, 1940.

On behalf of the Unani Pharmacopoeia Committee, I feel it is my duty to place on records out sincere thanks and appreciation to the Government of India, PUM, Ghaziabad, CCRUM, Scientists and Unani Scholars for the whole hearted co-operation in preparing the monographs on single drugs. I thank all the members of the Unani Pharmacopoeia Committee without whose co-operation this volume would not have seen the light of the day.

I place on record" my sincere thanks to Hakim (Mrs) Aliya Aman, Dy. Advisor(U) and Member Secretary - Unani Pharmacopoeia Committee, her collegues Hakim Sham sui Afaq, R.O. (U), Hakim Syed Ahmed Khan, A.R.O.(U), Hakim M. Jalees Subhani, R.A. (U), Sh. N. Padma Kumar, R.A. (Bot), Sh. Ashok Kumar, R.A. (Chem), Shri Ramesh Kumar, Asstt. Secretary APC, Unani Pharmacopoeia Committee and his staff.

Shri Rais Ahmed, Urdu typist and other office colleagues have done a good work in convening this meetings of the Unani Pharmacopoeia Committee and completing this work, deserves my thanks.

I also thank Dr. R. U. Ahmed, Director PUM and their colleagues for their help in making the technical data available to the Unani Pharmacopoeia Committee.

Lastly, I thank all those who have directly' or indirectly contributed III the preparation of this volume.

The Unani System of Medicine, one of the oldest systems of medicine, had its origin in Greece. The great Greek Philosopher & Physician Hippocrates (460 - 377 B.C.) is the founder of Unani Medicine, later Galen, Rhazes and Avicenna enriched the System.

Unani System of Medicine was introduced in India by Arabs in 13th Century. Due to its efficacy. and scientific base, it was accepted by masses and this system took firm roots in India.

Unani System prefers treatment through single drugs and their combination in raw form, rather than compound formulations. In Unani System, there is a great emphasis on proper identification of single drugs. Dioscorides ( 40 - 90 A.D.) is known in the field of Ilmul Advia (Pharmacology) as its founder. He described about 500 single drugs. Later on, Galen, Abu Hanifa, Ibne Sena etc. contributed a lot to this field.

Ibne Baitar (1176 - 1248 A.D. ), the great scientist of Unani medicine, compiled a book on Pharmacology after extensive field survey and research describing 1500 single drugs used in Unani Medicine.

The practising physician was solely responsible for identification and collection of single drugs, the manufacturing process of compound formulation was done by the physician themselves. In the process he was free to substitute any drug and change formulation. All this lead to a state of confusion and uncertainty about the identification of single drugs and also lack of uniformity in compound formulations.

Commercialisation of Drug Industry lead the Drug houses manufacturing compound formulations which were available through shelves. At this juncture, it was felt that a statutory control should be ensured in the interest of profession and public. The Govt. of India considered it expedient to utilise the existing .law "The Drugs & Cosmetic Act, 1940" to control the Unani, Ayurvedic & Siddha Drugs in a limited manner. The act was accordingly amended in 1964, namely

1. The manufacture should be carried under prescribed hygienic conditions, under the supervision of a person having prescribed qualification.

2. The raw material used in the preparation of drugs should be genuine and properly identified.

3. The formula or the true list of all the ingredients used in the drugs should be displayed on the label of every container.

To achieve the desired effects of drugs on the patients, it is essential to procure the standard and authenticated single drugs, and subsequently the compound formulations. For this very purpose, there is an urgent need to develop the pharmacopoeial standards of Unani medicines. Availability of pharmacopoeia will have tremendous effect on the quality of Unani drugs.

For the development of Unani pharmacy on modem lines and to enable the Unani medicine to withstand commercialisation. the Government of India has accepted the recommendations of the Unani Advisory Committee. The Govt. in their letter no. F. 25/2/63 - RISM dated 2nd March, 1964 constituted the first Unani Pharmacopoeis Committee consisting of the following experts for a period of three years with effect from the date of its first meeting :-