Introduction:
Unani medicine is the ancient Greek system of medicine that evolved throughout the ancient world, and which was fostered in the Islamic realms. Classical Arab-Islamic medicine was conventionally attributed to the ancient Greeks; thus, it came to be known as Unani (from the Arabic Yūnānī for 'Greek'). Hippocrates (c. 460-375 BCE) was known as the father of this system of medicine, and it is he who was the first true medical codified and commentator, building on the theoretical work of his contemporary Democritus (c. 460-370 BCE). Their teachings were propagated by the two sons of Hippocrates, Thessarlus, and Draco, and a student Polybus. Subsequently, Unani medicine was espoused by several competent Greek scholars who significantly developed the Hippocratic system throughout the Alexandrian world, from Egypt to Bactria. Later, under the benign patronage of Abbasid Caliphs, the Arab and Persian physicians imbibed the Unani medicine and elevated it to the highest pinnacle, surpassing the achievements of the ancients and dynamically and persistently developing this medical paradigm for about a millennium (Quamri et al., 2002).
A drug is defined as any chemical substance that alters the physiology or psychology of an organism when ingested is referred to as a drug (Stedman T, 1920). A clear understanding on drug and diet and their effects has been described in Unani texts, thus Dawa (drug) is defined as a substance which acts the body with its quality (Kaifiyat) and produces effect, and does not become the part of body, such as Mako (Solanum nigrum), Kasni (Cichorium intybus), Aftimoon (Cuscuta reflexa), Afsanteen (Artemesia absynthium), etc, and Ghiza (diet) is defined as the substances after administration it metabolized to become part of the body (nutrition and energy) like wheat, rice, egg, and other protein, fat, etc (Sina I, 1993; Nafees B,1954). Further, categorised it as Ghiza e Dawai (diet cum drug) where substances mainly used as diet, contain certain pharmacological actions. As they help to maintain individuals' overall health such as wheat, gram, egg, fish, certain vegetables and fruits, etc. (Baig et al., 2015) whereas, Dawa e Ghizai (drug cum diet) are the compounds contain nutritional components besides their primary usage as drugs, like Amla (Phyllanthus emblica), honey, Pudina (Mentha arvensis), Hulba (Trigonella foenum-graecum), Lettuce (Lactuca sativa), etc. Ghiza e Dawai has nutritional value more than the therapeutic value whereas in Dawa e Ghizai therapeutic value is more (Zaman et al., 2013).
According to Unani medicine, any substance when ingested acts upon the body in three ways i.e by Kaifiyat (Quality), Surate Naueiya (by active constituents), or Madda (matter) (Majoosi AI, 2010; Sina I, 2010; Quamri MA, 2019).
The Greek physician Hippocrates's often-quoted, nearly 2,500 years ago, "Let food be thy medicine and medicine be thy food". Referred to functional foods and dietary supplements, these products have been defined as "any substance that may be considered a food or part of a food and provides medical and health benefits including the prevention and treatment of disease. Perhaps the most descriptive term used to refer to this part of food/products are "nutraceuticals" (Biesalski HK, 2001). Nutraceuticals may contain substances that are “natural” expressed intent of treatment or prevention of disease but may not be generally recognized as safe (Ross S, 2000).
To promote AYUSH systems of healthcare within the Ministry of Health and Family Welfare, the Government of India established a separate Department of Indian Systems of Medicine and Homoeopathy (ISM&H) in 1995. In November 2003, the Department of ISM&H was renamed the Department of AYUSH, which stands for Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homoeopathy. On November 9th, 2014, the Department of AYUSH was elevated to a full-fledged Ministry of AYUSH. The Ministry of AYUSH has a mandate to promote and propagate Indian systems of Medicine and Homoeopathy, in India and globally (Introduction).
Indian Pharmacopoeia Commission (IPC) under the Ministry of Health and Family Welfare (MoHFW), Government of India is established to improve the quality and safety of medicines by updating the existing monographs on a regular interval and adding new monographs. The IP or any part of it, has got legal status under the Second Schedule of the Drugs & Cosmetics Act, 1940, and Rules 1945 thereunder. It further promotes the rational use of generic medicines by publishing the National Formulary of India (Kalaiselvan et al., 2015).
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, in collaboration with IPC it monitors the safety of medicines and takes regulatory intervention if required and it propagates the medicine safety-related decisions to various stakeholders (Kalaiselvan et al., 2015).
Pharmacopoeia is an official source that contains national and international rules that must be complied with legally and scientifically regarding substances, materials, drugs0, devices, and methods used in the pharmaceutical field and pharmaceutical production (Yapar EA, Ozdemirhan ME, 2020). According to the World Health Organization (WHO), sixty-eight different pharmacopeias are utilized effectively in fifty-six nations worldwide (Review of world pharmacopeias). A national pharmacopeia is developed and published by the national pharmacopeia authority of their country (Yapar EA, Ozdemirhan, ME, 2020).
On behalf of the Ministry of Health and Family Welfare, the Indian Pharmacopoeia Commission (IPC) publishes the Indian Pharmacopoeia. The Indian Pharmacopoeia includes specifications and analysis protocols for evaluating the quality of pharmaceutical substances, excipients, and dosage forms. A product's definition, description, identification, packaging, storage, specifications, impurities, assay, and specific tests, as well as one or more analytical procedures for each test, acceptance criteria, and other requirements, are all included in the IP monograph for an official substance or preparation (Indian Pharmacopoeia, 2010).
A Formulary is a manual containing clinically oriented summaries of pharmacological information about selected drugs. The manual could also provide administrative and regulatory details on the prescription and distribution of medicines. A national formulary typically focuses on readily available, reasonably priced medications that are pertinent to the treatment of diseases in a specific nation. Moreover, formularies are regularly developed for various industries, hospitals, and degrees of healthcare (National Formulary of India).
Development of the Unani Pharmacopoeia
The task of developing the Unani Pharmacopoeia has been entrusted to the Unani Pharmacopoeia Committee (UPC), comprising experts in Unani medicine, botany/ pharmacognosy, chemistry, pharmacology, etc. (Rai et al., 2020). The first UPC was constituted in March 1964 under the chairmanship of Col. Sir Ram Nath Chopra. Since then, this committee has been reconstituted several times (Unani Pharmacopoeia Committee, 2007). These pharmacopeia committees have contributed to the development and publication of Pharmacopeias and formularies of Unani medicine.
National Formulary of Unani Medicine (NFUM)
Formularies are the official compendia of classical Unani formulations derived from classical texts of Unani medicine. [19] The National Formulary of Unani Medicine, which contains 1229 formulations of Unani medications, is published in six parts. Certain analytical criteria and limits (standards) are provided in each monograph of Pharmacopoeia to ensure the quality of medicines. Details of formularies are enumerated in Tables 1–3 (National Formulary of Unani Medicine, 1981; 1994; 2001; 2006; 2008; 2011).
Unani Pharmacopoeia of India (UPI)
Pharmacopeias are the official compendia of regulatory quality standards of Unani single drugs (ingredients) and classical Unani formulations. The pattern and format of the UPI are more or less identifiable with different contemporary pharmacopeias such as the Indian Pharmacopoeia, the British Pharmacopoeia, and the United States Pharmacopeia, etc., with certain modifications (Rai et al., 2020). There are two parts of the Unani Pharmacopoeia of India: Part I (single drugs) and Part II (formulations). UPI Part I is published in six volumes and includes 298 monographs on Unani single drugs made from plants (single drugs), while Part II is published in four volumes and includes formulations, standard operating procedures, and quality standards for 200 traditional formulations that are taken from the National Formularies of Unani Medicine. Details about the volumes of the Pharmacopoeia are enumerated in Tables 4–5 (Unani Pharmacopoeia of India, 2007; 2007; 2007; 2007; 2008; 2009; 2009; 2010; 2016; 2019).
Pharmacopeia | Year of publication | No. of Monographs |
UPI, Part I. Vol. I | 2007 | 45 |
UPI, Part I. Vol. II | 2007 | 50 |
UPI, Part I, Vol. III | 2007 | 53 |
UPI, Part I, Vol. IV | 2007 | 50 |
UPI, Part 1, Vol. V | 2008 | 52 |
UPI, Part I, Vol. VI | 2009 | 48 |
Total | | 298 |
Various Unani Pharmacopeias have been written since ancient times and in a different eras which are termed as 'Qarabadeen’, which is also known as Anqarabadeen / Aqrabadeen meaning “Tarkeeb-e-Advia” (Formulating a drug) /Advia murakkaba ka dafter’ (office of compound drugs) (Arzani MA, 1998).
In India, fourteen Qarabadeen are approved by the Ministry of AYUSH, Govt. of India, and enlisted in the second schedule of the Drug and Cosmetic Act 1945 and Rules 1950. These are Qarabadeen-e Qadri by Hakeem Mohammed Akbar Arzani, Qarabadeen-e-Kabeer by Mohammad Hussain Khan, Qarabadeen-e-Azam by Hakeem Mohammed Azam Khan, Qarabadeen-e-Jadeed by Hakeem Ubaid ul Hafeez, Ilaj-ul Amraz by Shareef Khan, Bayaz-e-Kabeer Volume II, and Kitab al-Taklees by Hakeem Mohammad Kabiruddin, Miftah-ul-Khazain by Kareem Baksh, Ma’dan al-Akseer by Firozuddin, Makhzan- ul- Murakkabat by Ghulam Jeelani, Al Qarabadeen-e-Jadeed by Kabiruddin, Kitab al-Taklees by Abdul Hafeez, National Formulary of Unani Medicine and Unani Pharmacopoeia (Lohar DR, 2006).
Numerous other pharmacopeias were also compiled. Most outstanding among them are Khazain ul Advia by Hakeem Najmul Ghani, Qarabadeen Baqai by Hakim Baqauddin, Qarabadeen Akbari by Hakeem Akbar Arzani, Qarabadeen Latifi by Hakim Abdul Latif, etc. (Akbarabadi HMM, 1998; Preckel C, 2015).
Roman claims that Dioscorides was the most well-known Pharmacopian by the first century AD. His most significant contribution Kitab-ul Hashaish includes 1200 medicinal herbs, 35 animals, and 90 minerals origin drugs (Steinhagen H, 2011). A century later, Galen (130–200 A.D.), a distinguished physician, made a significant contribution to Unani literature. He authored altogether 129 books, which carry Pharmacopoeic content also. Among them, Kitabul Adwiya-al Mufrada is an exclusive book on pharmacopeia (Saad B, Said O, 2011). Other Prominent Pharmacopians were Zakariya Razi, Ali Ibn Abbas al Majoosi, Ibne Sina, Ibne Rushd, Ibne Zohr, Al-Biruni, etc. The earliest medical books with both medical information and pharmacopoeic materials are, Masarjuwaih's Kunnash, Hubaish A'sam's Kitabul Advia Mufradah, Rabban Tabari's Firdausal Hikmah, Zakaria Razi’s Kitab Saidnah (Steinhagen H, 2011). Other Pharmacopoeic compilations are Ibn al-Baytar's Kitabul Jami AI-Advia and Kitabul Mughni, Ibn Wafid's Kitabul Advia Mufradah and Mujarrabatfi Tibb and Al-Ghafiqi’s Al- Advia Mufradah (Said HM, 1969).
Revision of the National Formulary of Unani Medicine and the Unani Pharmacopoeia of India.
In recent years, there has been a renewed interest in the traditional system of medicine in both developing and affluent countries of the world. However, there is a need to maintain their purity, quality, and safety by subjecting the finished products to rigorous scientific testing and laying down pharmacopoeial standards for both Singh and Compound drugs.
It is the need of the hour to revise the National Formulary of Unani Medicine and the Unani Pharmacopoeia of India. The first National Formulary of Unani Medicine was published by the Ministry of Health and Family Welfare in 1981 and the first Unani Pharmacopoeia of India in 2007.
Pharmacovigilance of Unani Medicine with respect to its Pharmacopeias and Formularies
Pharmacovigilance is the science of detection, understanding, assessment, and prevention of adverse drug reactions and related untoward effects (WHO, 2004).
In Unani, the concept of "Pharmacovigilance" is vibrant. Ibn-i-Sina pioneering work Al-Qanoon Fit tib mentioned the concept of adverse drug reactions and its prevention and management as Muzir wa Musleh (Sina I, 2010). Unani pharmacologists had mentioned that drugs having temperaments of 3rd and 4th degree can produce serious adverse effects (Rahman et al., 2008).
The Drugs were classified into four categories (1, 2, 3, and 4 degrees) based on the Mizaj (temperament). The first-degree drug causes more coldness/hotness than usual, but it has no effect on the physiological condition, and hotness/coldness can be felt locally. Second-degree drugs do effects, that can be examined but not so much that they disrupt everyday routine life. Third-degree drugs have effects that can be analyzed and impaired the normal physiological functioning of the body, but they are not strong enough to cause death. Fourth-degree drugs have such severe effects that the physiological functioning of the body is disrupted; these drugs are toxic. (Khan MA, 2012). To counteract the harmful effect, drugs are rectified or detoxified. These medications will be used after proper Mudabbar / detoxification/rectification as per the standard prescribed in Unani texts; otherwise, these medications may cause adverse effects (Viquar U, 2022). The process of detoxification or purification of the drugs is called Tadbir-e-Adviyah and the drugs which undergo this process are suffixed with the term “Musaffa”. Tadbir-e-Adviyah is done to enhance the therapeutic action of the drug and to reduce its toxicity (Kabeeruddin M, 2010).
The drugs such as Afyun (Papaver somniferum Linn.) Rasaut (Berberis aristata Dc.), Anzaroot (Astragalus sarcocola Dymock.), Bhilawan (Semicarpus anacardium Linn.), Habb-us-Salateen (Croton tiglium Linn.), Chaksu (Cassia absus Linn.), Azaraqi (Strychonos nuxvomica Linn.), Kibreet (Sulphur), Samm-ul-Far (White Oxide of Arsenic), Shingraf (Compound of Mercury And sulfur), Seemab (Mercury), Khabs-ul-Hadeed (Iron Oxide), Beesh (Aconitum napellus Linn.), Hartal (Arsenic Trisulphide), Sang-e-Surma (Lead Sulphide), Ajwayin (Trachypermum ammi (Linn) Sprague), Zeera (Carum carvi Linn.), etc mentioned in National Formulary of Unani Medicine should be used in formulations only after proper detoxification.
Sometimes drugs are used as an alternative to some other drugs - Abdal Advia. There are certain conditions when alternative drugs are used as Abdal Advia; like when the drug is unavailable, when it is too expensive, when there is a religious prohibition on the use of the drug, or if the toxicity is more and benefits are less even after detoxification, the alternative drug is used (Srikanth et al., 2020; Naquibuddin et al., 2021). In the National Formulary of Unani Medicine and the Unani Pharmacopoeia of India, so many compounds comprise drugs that are not available or obtainable like Aqrab (Scorpion), Jundbedaster (Castorium (Caster — Beaver)), Amber (Amber), Kaf-e-Darya (Cuttlefish Bone) etc, and also, some drugs that are used in formulations are too costly like Mushk (Musk), Tila (Gold), Yaqoot (Ruby) etc.
Sometimes, another drug is used with the therapeutic drug, to reduce the side effects. Such a drug is called Musleh (Corrective). Some drugs are diluted with water so that their harmful effect may be reduced e: g sulfur-containing drugs. Opium, Hyoscyamus relieve pain but weaken the heart, so Abresham, Saffron can be used as musleh. If laxative drugs irritate the intestine, mucilaginous drugs can be added to reduce irritation. If hemostatic drugs produce constipation, some laxatives may be given. If drugs are combined carefully, they will give better results with fewer side effects (Ghani N, 2011; Kabeeruddin M. 2007).
The old methods of manufacturing drugs have now been changed by modern technology. The need was felt to ensure standard and quality control for Unani drugs. The Government of India thought it was appropriate to use the current Drugs and Cosmetics Act, 1940 in light of the current trend of commercialization in the manufacturing and sale of Unani medicines and to protect the interests of the Profession and Public. The act was accordingly amended in 1964 to ensure limited control over the production and sale of the Unani Medicines namely:
l The manufacturing process should be carried out under the required hygienic guidelines and with the guidance of a qualified individual.
l The raw materials used to prepare drugs should be original and properly identified.
l Each containers labile should include a formulation or accurate list of all the ingredients that make up the medication.
The requirement that the ingredients list be presented on the label will allow the analyst to confirm label claims and, in that regard, bind the maker. Plans are made to develop and establish physical, chemical, and biological tests as needed to identify the medicine, determine its quality, and find adulterants. Thus, it is crucial to establish Unani Medicine Drug Standardization Testing and Control Labs at the Central and Regional Levels (National Formulary of Unani Medicine, 1981; 1994; 2001; 2006; 2008; 2011).
Establishing the Pharmacopoeial standards for herbal medicine, both for single drugs and formulations, is essential, as Pharmacopoeial standards are important and are mandatory for the implementation of the drug testing provisions under the Drugs and Cosmetics Act, 1940, and Rules thereunder. These standards are also essential to check samples of drugs available in the market for their safety and efficacy (Annual Statistical Publication, 2021).
The quality of the pharmaceutical products used must comply with relevant internationally accepted criteria. Quality in pharmaceutical products is a broad concept covering all aspects that affect the efficacy and safety of these products. All of the measures that require the assurance of pharmaceutical quality constitute the quality assurance system. The Quality Assurance system consists of Quality Management (QM), Quality Assurance (QA) Good Manufacturing Practices (GMP), and Quality Control (QC). Pharmaceutical products are subjected to quality control criteria and analysis within the scope of internationally accepted standards and guidelines specified or guided, including formulation, place, and form of use. The many facets of quality control assessments in pharmaceutical products are clarified by pharmacopeias (AlgınYapar et al., 2020). To produce a consistent pharmaceutical product, pharmaceutical scientists should essentially take great care to choose the material in line with the necessary standards and quality requirements (Van Heugten et al., 2017).
Conclusion
As the Unani system of Medicine continues to evolve and larger numbers of consumers are added, it will be imperative for committees to assess the processes of manufacturing drugs and develop innovative approaches to make the products safe and effective. A periodic review of the National Formulary of Unani Medicine and the Unani Pharmacopoeia of India is essential to identify, adapt, and apply innovative formulary management strategies, especially for those drugs which are of fourth-degree temperament and have proved toxicity. Some of the drugs are not available in the market, so the quality issue is of great concern in case of substitution. In addition, committees will need to consider drug identification to overcome the adverse drug reaction. The periodic review is imperative for effective formulary and pharmacopeia management.
Conflict of Interest
The authors declared no conflict of interest.
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