THE UNANI PHARMACOPOEIA
THE UNANI PHARMACOPOEIAOF INDIAPART - IIVOLUME - II(Formulations)First EditionGOVERNMENT OF INDIAMINISTRY OF HEALTH AND FAMILY WELFAREDEPARTMENT OF AYURVEDA, YOGA & NATUROPATHY,UNANI, SIDDHA AND HOMOEOPATHY (AYUSH)NEW DELHI2010i
Ministry of Health & Family Welfare, Government of IndiaDepartment of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH),ISBN: 81-87748-17-6First Edition : May 2010, 5000 copiesPrice: Rs. 275/-Published by : Central Council for Research in Unani Medicine,On behalf of : Government of India, Ministry of Health & Family Welfare (Deptt. of Ayush)Govt of IndiaWebsite: http://unanimedicine.comPrinted by: Rakmo Press Pvt. Ltd., C-59, Okhla Industrial Area Phase-I, New Delhi-110020ii
CONTENTSPage FOREWORDv PREFACEvii INTRODUCTIONxi LEGAL NOTICESxv GENERAL NOTICESxvii ABBREVIATION OF TECHNICAL TERMSxxiv CONTRIBUTING INSTITUTIONSxxv r e-Haiz(NFUM-II)95.Dawa-e-Salasul M-II)3415.Itrifal Mulayyan(NFUM-V)3716.Itrifal Muqawwi Dimagh(NFUM-V)4017.Itrifal-e-Muqil -II)5121.Itrifal Zamani(NFUM-V)5422.Jawarish Amla Sada(NFUM-V)5723.Jawarish-e-Aamla Ambari(NFUM-II)6024.Jawarish-e-Aamla iii
26.Jawarish-e-Darchini -II)7930.Jawarish-e-Kamooni Kabir(NFUM-II)8231.Jawarish-e-Kamooni Mushil(NFUM-II)8532.Jawarish-e-Ood 34.Jawarish-Tamar sihi -Sandal(NFUM-II)12245.Majoon-e-Yahya Bin yaq-e-Arba(NFUM-I)140 APPENDICES143 CONTENTS OF APPENDICES145 WEIGHTS AND MEASURES289 PHARMACOPOEIA COMMITTEES AT A GLANCE290iv
,l- tytkS. JALAJAFOREWORDThe Govt. of India has been constantly supporting Unani and other Indian Systems ofMedicine for their optimum utilization in the Health Care Delivery System. The Govt. hastherefore all along been concerned about the quality and efficacy of these Systems. Pursuantto this, the Govt. as early as 1964, amended the Drugs and Cosmetics Act, 1940 to bringwithin its purview production and sale of Ayurveda, Unani and Siddha drugs. Provisions made,rules framed, and steps were initiated for laying down standards for single and compoundformulations so as to ensure smooth and effective enforcement of these provisions.Globally also, there has been an uprise in demand for traditional systems of medicineincluding Unani Medicine. Therefore, the Govt. of India in tune with the concern of the WHOhas emphasized the need for effective maintenance of quality of these herbal productsincluding those used in Unani Medicine. For this purpose, Pharmacopoeia Committee(s)were set up for different Systems which were mandated for laying down standards of varioussingle and compound drugs. Since the treatments are holistic in nature, it was consideredthat physical and chemical parameters alone, may not be sufficient to give a true picture ofthe quality of the drugs at all times and therefore, biological parameters were included. Thisprocess of improvement continued over the years and different Pharmacopoeia Committeesincluding Unani Pharmacopoeia Committee evolved methods for standardization of suchdrugs.Chemical standards are quick to operate and reproducible in any laboratory and theinstrumental methods like HPLC, HPTLC, GLC, Atomic Absorption Spectroscopy, etc. givemore conclusive results. However, any drug intended for therapeutic use and expected toperform its prescribed efficacy has to have a dependence on its quality, strength and purity.Therefore, there has all along been emphasis on generating facility for such provisions.Recently established Pharmacopoeia Commission is supposed to give meaningful directionand speed to the work.At present, herbal drug scenario is not very encouraging in the country for reasons ofquite generalized quality parameters for testing of these drugs being adopted by the industry.v
Very few Pharmaceutical firms have their in-house laboratories for determining standardmethods of preparation, operations and quality parameters for finished products, but even insuch cases, these is no uniformity in operating procedures. Taking this fact into consideration,the Govt. of India have introduced cluster schemes to provide support to industry for havingsuch facilities on share basis. It is hoped that the move should be welcomed, and moreindustries will benefit with this venture.Unani System of Medicine has a large number of single and compound drugs whichare used by practitioners and accepted by the population with confidence. In consideration ofthis fact, the Central Council for Research in Unani Medicine has been assigned theresponsibility of developing standards and Standard Operating Procedures for the manufactureof compound Unani drugs. The Council on its own, I am told, had developed standards for272 single and 385 compound formulations. After having been assigned the additionalresponsibility of the Unani Pharmacopoeia Committee, the Council reorganized itself in thissector. So far standards for 298 single drugs, developed by the Conncil have since beennotified. Future, the Council developed standards for compound formulations according toprotocol approved by Unani Pharmacopoeia Committee and a volume containing UnaniPharmacopoeia Committee standards for 50 formulations was brought out by the Councilearlier.With the continuous efforts, another volume of Unani Pharmacopoeia of India containingstandard Operating Procedures and standards of 50 Unani compound drugs developedlaboratories have been approved by the Unani Pharmacopoeia Committee and is beingpresented for the use of industry as well as Drug Enforcement Authorities. This volume is aresult of untiring efforts of scientists from different laboratories that Unani Pharmacopoeia ofIndia, Part-II, Volume II will be welcomed by scientists and researchers, regulatory authoritiesand manufacturing units of Unani drugs, alike. Any suggestion(s), for improvement of thesubsequent editions are welcome.I have the pleasure in acknowledging the good efforts of the scientific staff of theCCRUM and all the experts associated with Unani Pharmacopoeia Committee for their valuablecontribution and help in bringing out this prestigious volume.( S. Jalaja )New DelhiJune 22, 2010vi
Jamia Hamdard00-91-11-2605-9662 (O)00-91-11-2605-9663 FaxHamdard University, ‘A’ Category - NAACHamdard Nagar, New Delhi - 110062, IndiaDr. G. N. QaziVice ChancellorPREFACEThe theoretical framework of Unani medicine dates back to the work of Hippocrates (460-377BC) who laid down the foundation for clinical medicine by his method of careful study andcomparison of symptoms. Unani system follows the humoural theory which postulates thepresence of four humours in the body: dam (blood), balgham (phlegm), safra (yellow bile) andsauda (black bile). A number of Greek scholars after Hippocrates followed by renowned Arabphysicians enriched the system considerably. Abu Bakr Mohammad Ibn Zakariya al-Razi andIbn Sina authored Kitab al-Hawi fi altibb and Al-Qanun fi al-Tibb, respectively, which werecompilations of their observations over the years. These monumental works later translatedinto Latin and other European languages and taught in medieval European universities andgreatly influenced western medical thought. This demonstrates that Unani system of medicinehas a strong tradition of written medical account. Unani system came to India mainly throughArab traders which later flourished under the state patronage of Muslim rulers. It soon becamea main stream medicine system with wide reach in rural and urban populace alike. During theBritish rule it witnessed a decline but in independent India it again resurged and now it is oneof the planks of AYUSH (Ayurveda, Yoga, Unani, Sidhha Government of India under the aegisof Department of AYUSH and its constituent the Central Council for Research in Unani Medicine (CCRUM) has spearheaded a number of projects aimed at compiling the traditionalknowledge in the field of Unani medicine. Publication of Unani Pharmacopoeia is one of suchambitious projects.A pharmacopeia is compilation of published, public quality standards for pharmaceutical ingredients, formulations and dosage forms. A standard may include acceptance criteria as well astest methods for determining the conformance of an ingredient, formulations or dosage formto the standard. Publication of a pharmacopeia is often a legal mandate, referenced innational law and enforced by governmental bodies. The fundamental purpose of the pharmacopeia is to promote public health and well being. Pharmacopeias, along with regulatoryagencies and pharmaceutical manufacturers, play a pivotal role in supporting the availabilityof safe, effective, and quality medicines. They serve as authentic sources of pharmaceuticalstandards in public domain. The ultimate beneficiaries of pharmacopeial standards publishedvii
in a pharmacopeia are healthcare professionals and patients. Today we have over 30pharmacopeias including a few on Indian systems of medicine.The Unani Pharmacopoeia of India Part II, volume I published in 2009 covered 50 Unaniformulations as individual Monographs. All of them from National Formulary of UnaniMedicine-I (NFUM-I)The present Pharmacopoeia (Part II, Volume II) includes fifty Monographs on Unani formulationseach annotated with NFUM number. The first monograph is on Arq-e-biranjasif (NFUM-V, 8.2;a liquid formulation) and the last one is on Tiryaq-e-arba (NFUM-I, 5.123) which is semi-solidformulation. For each formulation detailed description of compostions, method of preparation,physical description, physico-chemical parameters, storage, therapeutic uses, actions, doseand mode of administration are included in scientifically standardized terminology. Formulationscover a wide range from liquid preparations to powder, semi-solid and solid preparations.Formulation composition is described in Unani terms as well as scientific terms includingstandard taxonomic nomenclature of plants and animals. Each compostion is described inmetric unit. Similarly infomation of composition is complete with type of animals or plant partsused such as leaf, stem or root. Wherever applicable, detailed methods of identification suchas those with microscopy or thin layer chromatography (TLC) are described for differentformulations.Doses are described in metric units such as ml, gm or mg. Actions are described in Unaniterms as well modern scientific terms. With such detailed information of pharmacologicalaction of different formulations it is expected that this publication will increase interest inUnani system amongst general medical practitioners.This pharmacopeia includes seven Appendices. Appendix-I contains information onapparatuses, for tests and assays. Appendix-2 described tests and determinations. Someapparatuses have been graphically presented. Each chemical test and process has detaileddescription of apparatuses, reagents used and methods of analysis. Analytical procedure ofafatoxins which are the major contaminants of concern with carcinogenic potential, pesticidesand heavy metals have been included in this Appendix. A detailed description of physical testsand determinations is provided in Appendix-3. These tests also include complete descriptionof apparatus, test procedure and analysis of data. Reagents, solutions and herbs have beendescribed in Appendix-4. In this section procedure of preparation of standard reagents havebeen described including the method of preparation of stock solution. This section containsspecific informations on crude Unani drugs with their detailed description. Therefore, a readerof this Unani Pharmacopoeia will find description on Unani crude drugs such as Abresham,Gaozaban, Magz-e-badam, Namak-e-sang, Raskapoor, Sirka, Tukhm-e-balanga, Warg Nukraand Zeera Siyah to name a few.Appendix-6 contains detailed description of chemical tests and assays generally focusing onanalysis of chemical constituents such as phenolics, tannins, sugars, curcumin, and metalssuch as aluminium, iron, copper, mercury etc. Analytical procedure for inorganic compoundsis also provided. Finally, it also covers analysis of vitamin C. Appendix-6 elaborates differentprocesses employed in preprations of Unani formulations such as Daq-wa-sahaq (poundingand grinding, Ehraq-e-adviyah (burning), Ghasi-e-adviyah (purification of drug), Neem-kobkarna (bruising), Tadbir-e-adviyah (detoxification of drugs), Tahmis-wa-biryan (roasting orviii
parching), Tarqiv-e-adviyah, Tasfiyah-adviyah (cleaning process) and Tasveel-e-adviyah(sieving). This Unani Pharmacopoeia also includes methods of preparation such as Huboobo-aqras, Marham, Qairooti and Zimad, and Qiwam (consistency) for jawarish, majoon, itrifal,halwa and dawa.Finally, an Appendix (No. 7) on wights and measures and an Appendix (N0. 8) on Bibliographymake up this Pharmacopoeia a complete document of reference.Prepareation of this Unani Pharmacopoeia was a massive effort. The Committee membersmet a number of times to finalize the draft. All the members enthusiastically contributed tothis gigantic task and provided critical inputs in various forms.I appreciate the efforts and persevernace of Dr. Mohammad Khalid Siddiqui, Director General,CCRUM, New Delhi and researchers and Unani scholars associated with the Council. It wasnot possible to accomplish tha task of prepatation of this Unani Pharmacopoeia without theirtireless support and valuable contributions.I also put on record a deep sense of appreciation for Secretary and Joint Secretary, Departmentof AYUSH, Government of India for their keen interest in this project, in particular and promotionof traditional medicine systems including Unani system, in general.It is hoped that the publication of Volume II, Part II of this Pharmacopoeia will meet thestatutory requirement and steer a new level of scientific understanding of the one of the mostvibrant medicine systems of the world.(DR.G.N.QAZI)ChairmanUnani Pharmacopoeia CommitteeGovernment of Indiaix
x
INTRODUCTIONThe Unani system of medicine owes, as its name suggests, its origin to Greece. It was theGreek philosopher-physician Hippocrates (460-377 BC) who freed Medicine from the realm ofsuperstition and magic, and gave it the status of Science. The theoretical framework of UnaniMedicine is based on the teachings of Hippocrates. After Hippocrates, a number of other Greekscholars enriched the system considerably. Of them, Galen (131 – 210 AD) stands out as the onewho stabilized its foundation, on which Arab physicians like Rhazes (850 – 1037 AD) constructedan imposing edifice.Unani Medicine got enriched by imbibing what was best in the contemporary systems oftraditional medicine in Egypt, Syria, Iraq, Persia, India, China and other Middle East and Far Eastcountries. It also benefited from the native medical systems in vogue at the time in various parts ofCentral Asia. That is why this system is known, in different parts of the world, with different namessuch as Greco-Arab Medicine, lonian Medicine, Arab Medicine, Islamic Medicine, Traditional Medicine,Oriental Medicine etc.Unani system of medicine was introduced to India by the Arabs, and soon it took firm rootsin the soil. The Delhi Sultans, the Khiljis, the Tughlaqs and the Mughal Emperors provided statepatronage to the scholars and even enrolled some as state employees and court physicians. Thesystem found immediate favour with the masses and soon spread all over the country. During the 13thand 17th century Unani Medicine had its heyday in India.At present Unani system of Medicine is one of the Indian System of Medicine and has a longand impressive development record in India. Today India is the world leader in having large numberof Unani Educational, Research and Health Care Institutions in the country. It is a matter of pridethat Unani system of medicine forms an integral part of National Health Care delivery system.In view of the present trend of commercialization, the Government of India is very consciousof quality control and Good Manufacture Practices (GMP) of Unani Medicine. The Manufacturingof Unani Medicine is being regulated through Drugs and Cosmetics Act, 1940. Taking into considerationcommercialization, and quality control of Unani Drugs, the Government of India, Ministry of Health& Family Welfare has constituted the Unani Pharmacopoeia Committee, consisting of Experts UnaniPhysicians, Chemists, Pharmacognocist, Botanists and Pharmacologists. The main function of thisPharmacopoeia Committee is to prepare National Unani Formulary and Unani Pharmacopoeia ofIndia.In view of the large scale commercialization of the Unani Drugs the Government of India, witha view to ensure safety and efficacy by maintaining standards of Unani products took a number ofsteps to ensure quality control of drugs. The manufacture and sale of Unani drugs is regulated bythe provisions of Drug and Cosmetic Acts 1940 as amended from time to time. The enforcement ofprovisions of Drugs and Cosmetic Acts including Good Manufacturing Practices (GMP) has led toensuring Quality of Unani products. The Unani Pharmacopoeia Committee was set up in 1964 byGovernment notification and is mandated for laying down standards for Single as well as CompoundDrugs under the Chairmanship of Col. R.N. Chopra vide letter No.:F.25/63-RISM dated 2nd March1964 and since then the Pharmacopoeia Committees have been functional and renowned expertshave been associated with the task of finalizing the standards by the Pharmacopoeia Committee.The Unani Pharmacopoeia Committee has also taken ambitious task of laying down NationalFormulary of Unani Medicine in which the formulations and their standard composition has beennotified for being followed by the Drug Industry.xi
The details of different Committees may be seen in the appendix to the Pharmacopoeia.The composition of the present Pharmacopoeia is as follows:Official MembersDrug Controller General (I)(or his representative),DGHS, Nirman BhawanNew DelhiMember (Ex-officio)The DirectorPharmacopoeial Laboratory of Indian MedicineCentral Govt. Office Complex,Kamla Nehru NagarGhaziabad – 201 002Member (Ex-officio)The DirectorCentral Council for Research in Unani MedicineJanakpuriNew DelhiMember SecretaryThe DirectorNational Institute of Unani MedicineKottigepalya, Magadimainain RoadVishwaneedom PostBangalore – 560 009Member (Ex-officio)Advisor (Unani)/Deputy Advisor (Unani)Department of AYUSHMinistry of Health & Family WelfareIRCS BuildingNew DelhiMember (Ex-officio)Non-Official MembersProf. Dr. M.S.Y. KhanHamdard UniversityHamdard NagarNew Delhi – 110 062Prof. Hm. S. Zillur RehmanIbn-e-Sina AcademyAligarh – 202 001MemberDr. Asad MueedResearch and Development DivisionHamdard DawakhanaDelhi – 110 006MemberMemberxii
Prof. S.M. AshrafDoharra MafiAligarhMemberDr. E.H. QureshiTope DarwazaLucknow-3MemberProf. Shakir Jamil,Hamdard UniversityHamdard NagarNew Delhi – 110 062MemberProf. Dr. S.H. AfaqP.G. Deptt. of Ilmul AdviaA.K. Tibbia CollegeAMU, AligarhMemberProf. R.K. KharFacul
The Unani Pharmacopoeia of India Part II, volume I published in 2009 covered 50 Unani formulations as individual Monographs. All of them from National Formulary of Unani Medicine-I (NFUM-I) The present Pharmacopoeia (Part II, Volume II) includes fifty Monographs on Unani formulations each annotated with NFUM number.
Unani Pharmacopoeia of India, Part-II, Vol. III, would be official. If considered necessary these standards can be amended and the Pharmacopoeia Commission for Indian Medicine & Homoeopathy is authorized to issue such amendments. Whenever such amendments are issued, the Unani Pharmacopoeia of India,
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The Unani Pharmacopoeia Committee, under the chairmanship of Dr. G.N. Qazi, has been responsible for taking up stupendous task of finalising editions of volumes of National Formularies of Unani Medicine as well as Official Unani Pharmacopoeia
National Unani Formulary and Unani Pharmacopoeia of India. The Ist Unani Pharmacopoeia Committee was constituted under the Chairmanship of Col. Sir Ram Nath Chopra, vide letter No. F-25/63-RISM dated 2nd March 1964. The 2nd, 3rd and 4th UPC was constituted under the Chairmanship of Prof. Hussain Zaheer vide Not
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