Every nation has its own form of medicine system that is rooted into its culture. According to the WHO’s report, 70% to 95% of the people across the world use the herbal drugs and the Traditional Medicine(TM) system for their primary healthcare purposes. It said, More than 90% of the people in Africa, 70% in India, 70% in Germany, 48% in Australia, 70% in Canada, 42% in America, 39% in Belgium and 76% in France use herbal drugs for meeting their healthcare requirements.
India also has its system of medicines viz., Ayurveda, Siddha, Unani and Sowa Rigpa, which has been accepted by WHO. Ayurved can be considered as one of the oldest traditional medicinal systems of the world. However, among thousands of Pharmaceutical companies in India, only few manufactures are doing more than a million dollars’ business to meet the growing demand for Ayurvedic medicine and astonishingly, Siddha Medicine considered as a heritage of Tamil Culture and having potent formulations has not yet been introduced outside the state of Tamil Nadu.
What is TM.
TM i.e Traditional Medicine can be considered to have three main categories ;
One. Codified medical systems ; Codified medical systems include great traditions which have evolved over 3-4 millennia and include Ayurveda, Siddha, and Unani in the Indian subcontinent and traditional Chinese medicine and acupuncture in China. These medical traditions have a unique understanding of physiology, pathogenesis, pharmacology, and pharmaceuticals which are different from Western biomedicine,
Two. Folk medicine ; Folk medicines are that traditional knowledge systems which are more often orally transmitted, have been generated by communities over centuries, and use components of the ecosystem which are locally available and accessible . Folk medicine has not been formalized and is diverse and adaptable based on changing contexts. And
Three. Allied forms of health knowledge ; Allied forms of health knowledge include techniques which are related to wellbeing, though they are not purely medical systems, such as yoga, tai-chi, qi-gong, and different meditations and breathing techniques.
Developed countries are also moving towards the usage of herbal medicines used in TMs and relaxing their guidelines in the herbal market. European countries share major market 41% of herbal medicine with 70% practitioners who prescribe those medicines. As per WHO forecast, the global market value of herbal medicines (TM) will be $5 Trillion by 2050 having annual growth of 8%.
Moreover, with the development in Health Information Technology, one can notice that TM is also experiencing its rapid advancement.
Is India Ready ?
Realising the importance of TM long back in 1961, A diploma course in Ayurveda was launched in the third (1961–1966) five-year plan. Therafter, The CENTRAL COUNCIL OF INDIAN MEDICINE was established in 1971, followed by Central Council of Homeopathy in 1973. The eighth (1992–1997) five-year plan lent considerable emphasis on the mainstreaming of Ayush, when a Department of Ayush became part of Health Ministry.
Every Five year plan laid considerable focus on TM, so that it could be integrated with the overall Health care system. The Government of India had also set up number of committees inorder to achieve this integration and as a means to facilitate healthcare access in rural areas where many Indians lack adequate health services.
The Department of Indian Systems of Medicine and Homeopathy (ISM&H) was first established in 1995 under the Ministry of Health, this was thereafter renamed as the Department of Ayurveda, Yoga and naturopathy, Unani, Siddha and Homeopathy or Department of AYUSH. . AYUSH is an acronym for Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy and are the six Indian systems of medicine prevalent and practiced in India and some of the neighboring Asian countries with very few exceptions in some of the developed countries
The department , thereafter was made into an official ministry in 2014. The Ministry of Ayush, is now a full fledged separate ministry responsible for the same functions as it did under Ministry of Health earlier.
The concept of mainstreaming of AYUSH was an idea in the 9th five year plan before it was actually implemented in the country by NRHM in 2005. AYUSH doctors were gradually co-located with various health facilities such as Primary Health Center (PHC), Community Health Center (CHC), sub district hospital, and district hospital (DH) as a result by March 2015, there were nearly 800,000 Ayush practitioners, over 90 per cent of whom practiced homeopathy or Ayurved, and India could export Ayush products of a net worth US$401.68 million in the fiscal year 2016–17.
Decades back AYUSH systems of medicine were limited to their own field with few exceptions in some states as health in India is a state issue. This took a reverse turn after the initiation of National Rural Health Mission (NRHM) in 2005 which brought the concept of “Mainstreaming of AYUSH and Revitalization of Local Health Traditions” utilizing the untapped AYUSH workforces, therapeutics and principles for the management of community health problems.
Several TM therapeutics are currently in use and few drugs have been included in the ASHA drug kit to treat common ailments in the community. At the same time Government of India has recognized few principles and therapeutics of Ayurveda as modalities of intervention to some of the community health problems. These include Ksharasutra (medicine coated thread) therapy for ano-rectal surgeries and Rasayana Chikitsa (rejuvenative therapy) for senile degenerative disorders etc.
The role and responsibilities of AYUSH doctors have been spelt out very carefully in their term of reference (TOR). As per the TOR, an AYUSH doctor should support in the implementation of national health programs after requisite training if required
Notwithstanding the above, sadly it contributes only $1 billion in the $62 billion global market, despite having a rich source of herbal production. The TM mainly use herbs, minerals and animal products for the production and India is using nearly 2000 species in TM but IS STILL a marginal contributor. . A 2018 study by the Confederation of Indian Industry (CII) estimated that the market share of Ayush medicines would be at around US$3 billion.
This is the sad story that is applicable to almost all Indian departments. For instance, India has one of the largest coastlines in the world but its contribution in sea food production is miniscule. Its not because the successive Govts did not do enough ; Committees were formed, Minsitries were formed. But still we lagged behind.
The reasons are enumerated below.
What ails the Indian TM industry.
Despite the high consideration given to the TM practice around the world and even in India since 1961, it seems to face remarkable challenges ;
One. . There is a lack of a reference standard for determining the proper dosage of the herbal medicine for the patients. This in turn has resulted in the creation of incorrect and incomplete information about the herbal drugs. The herbal drugs are commonly believed by people to have no side effects so many consumers regard them healthier than the chemical drugs. It is important to know that the irrational use of these medicines would be associated with increased risks endangering the treatment process success.
Two. This difficulty results from the remarkable differences in the methods applied for each type of intervention as well as physician education. Some TMs tend to focus on the physical aspects of the treatment systems while some other give more consideration to the spiritual and mental aspects , so there is a lack of treatment protocols and standardization .
Three. This has brought in a huge information gap between the TM practitioners and consumers . The WHO "Traditional Medicine Strategy 2014–2023" published by WHO states that althoughTM has been launched in more than 100 nations across the world and has transformed TM into an international industry, however, the lack of established treatment standards has weakened this type of medicine influencing its international advance, negatively.
Four. Lack of quality assurance instructions, lack of a universal unified terminology, lack of evaluation of the safety as well as the lack of patient information system in the TM-centered clinics or hospitals are among the other challenges.
For instance ; In the European Union, a complex regulatory framework for the management of the herbal medicinal products has been incorporated into the guidelines . According to these guidelines, all the herbal medicines should be in conformity with the good manufacturing practices and pattern. This pattern provides some insight regarding what information to be recorded in the herbal medicine prescription as well as its medical function.
Five. In the absence of Quality assurance , lack of established treatment procedures, the herbal drugs are not covered by the health insurance in many nations. In this regard, traditional Chinese Medicine database (TCMID) is the most comprehensive database in use in China representing remarkable advances in information integration . Besides the combinations of the herbs, this database provides the three-dimensional structures of the herbal combinations for research use.
IBM Corporation is also developing a technology that will assist the hospitals in China in standardizing the patient records for a group of hospitals in South China. Such technology will enable using the patient’s records for the treatment analysis.
Six. In the absence of such established procedures, The ministry of Ayush has been facing significant criticism for funding systems that lack biological plausibility and are either untested or conclusively proven as ineffective. Biological plausibility is an important part of the process of evaluating whether a proposed therapy (drug, vaccine, surgical procedure, etc.) has a real benefit to a patient or not . For a layman to understand ; in allopathic treatment after numerous clinical trials a procedure has been established as to how DIABETES will be treated, but in case of TMs this kind of procedure is not yet established scientifically, this is not withstanding the tall claims made by …..
Seven. There is also a criticism that Quality of research has been poor, and drugs have been launched without rigorous pharmacological studies and meaningful clinical trials .The ministry inorder to push the TM has been accused of promoting PSEUDO SCIENCE.
Eight. It is always the patient that makes the choice, so Integrating TM into mainstream health care would require research to understand the efficacy, safety, and mechanism of action of TM systems. Unless the patient is confident about the efficacy of TM he would go for the well established allopathic procedures.
Nine. . During ancient times the drugs were prepared by the physician himself in small batches for individual customers but over a period of time due to commercialization there is now a mass production of the medicines and in the absence of any standardization , quality is often compromised. Although there is an Ayruvedic formulary of India which gives the various formulations but there are numerous challenges ;.
In India, we have over 8500 licensed Ayurvedic medicine Manufacturers. Over 80% of the medicinal plants requirements by Ayurvedic Industry are obtained from wild collection from forests and waste lands and so there are massive quality issues that need to be addressed.;
- In most cases supplies are made by Traders most of these do not have adequate knowledge of medicinal plants. The Trader organizes collection of medicinal plants through children and women in these forest areas who many times can not differentiate between related plant species. Therefore many times manufacturing units receive substituted or adulterated plant materials.
- The problem gets further aggravated as most of the Ayurvedic medicine Manufacturers do not have stringent methods of Quality Controls for these plant materials.
- Further, confusion occurs many a times due to vernacular/local names by which the traders supply. It is a known fact that local names of several medicinal plants have different botanical identity in the region of their occurrence.
- The Acceptance Criteria in most of these Ayurvedic medicine manufacturers is different. This can definitely be deceptive many a times since crude drugs are received in dry form and in many cases in broken condition like small pieces of barks, roots and powders of leaves and flowers etc.
- Another major problem faced is of non-homogeneity of the materials. Many times collection is done from different regions with the result that there is no homogeneity of these materials both in their organoleptic characters (taste, colour etc) as well as in chemical constituents. Several times a mixture of mature and immature plant species are received which is difficult to separate.
Eleven. After this basic understanding of problems, when we see to apply Quality Control and Assurance Tests to Ayurvedic products, one realizes that there is a lack of Standardization of Raw Material and Manufacturing Processes.
Twelve.. Another point related to hurdles in this, is a fact that Ayurvedic product is made from varied sources of raw materials which are of plant, mineral and animal origin. These raw materials can be tested for Quality Control and Quality Assurance by highly sophisticated analytical instruments like HPTLC (High Performance Thin Layer Chromatography). But a final product containing number of various plant materials, minerals, and animal products renders it difficult to prepare Quality Control Master files for finished product, which is either polyherbal or many times herbo-mineral type.
Thirteen. One more problem is that, interim products which are added in final product are manufactured by different manufacturing processes and hence uniformity even in basic physical properties such as color, odour and taste can’t be the same for the same interim product manufactured by different manufacturers by employing different manufacturing processes of their own choice and convenience. Hence, it can be firmly pointed out that, total Quality Control and Quality Assurance of Ayurvedic products is not possible without Standardization of Manufacturing Processes.
Fourteen. Many decades back , based on the traditional documents available, Ayurvedic Formulary was published by concerned department as an Official document of Govt of India consisting of monographs of single drugs and compound formulations, in order to standardize the manufacturing process, But most of the pharmaceutical companies including GMP-certified ones do not strictly adhere to these documents due to the unavailability of mentioned source plants. None of the official bodies can assure whether the final product contains the same ingredients as mentioned in the label.
Failure of product validation with uniform ingredients due to afore-cited reasons as a result still remains a major hurdle for Ayurvedic medicine to find a breakthrough in international markets.
With the shift of medicine production from small-scale units to industrial marketing commodity, there emerged a practice of alteration/ addition/omission of drugs from classical formulae ( Ayurvedic Formulary) based on convenience resulting in non uniformity of ingredients in the same formulation manufactured by different pharmaceutical units
Suggestions ;
One. There is hence a need to undertake a project to review the old Ayurvedic Formulary compiled by Govt of India as an official document taking into consideration the new sophisticated manufacturing techniques and standardizing these manufacturing techniques and processes..
Two. WHO (World Health Organization), in 1992 had issued comprehensive guidelines for Medicinal Plant Materials and these guidelines can be very useful for ensuring consistency of Herbal Products. However, not many Ayurvedic medicine Manufacturers have been able to undertake these tests for want of proper R&D and Quality Control Laboratories. Details of the procedures are covered under major headings such as – Sampling, Determination of Foreign Matter, Macroscopy and Microscopy, Thin layer Chromatography, Ash Values, Extractable Matter, Specific Tests, Pesticide Residues, Arsenic and Heavy Metals, Radioactive Contamination and Microbiological Tests.
In an organized sector where Pharmaceutical Companies are involved in production of Ayurvedic Medicines, most of these guidelines are followed. However, since most of the traditional Ayurvedic medicine Manufacturers are in small-scale sector, they do not resort to such stringent tests. The Govt needs to prod them.
Three. It is important that the TM manufacturers must adhere to follow stringent measures to make India a major player in the TM manufacturing –
- Ensure authentic plant materials – Quality checks on Inventories/Vendor Validation
- Undertake proper sampling to ensure Homogeneity of the materials.
- Undertake quality control tests as per specification.
- Ensure compliance of process and product parameters – Process Standardization
- Undertake Microbiological Tests to ensure complete absence of all pathogens.
- Ensure complete documentation of all raw materials used along with quality control tests and production parameters – Quality Control Masterfile.
Conclusion.
Although, The Global Ayurveda Summit has been organized by CII the Confederation of Indian Industry, regularly since 2010 which has had a galvanizing effect on India’s Ayurvedic and tourism sector, but without undertaking the above measures, it is unlikely that India will emerge as a major contributor.
In the past, Global Ayurveda Festival (GAF) was being organised in Kerala as a regular feature which helped placing India on the global landscape of Ayurvedic healthcare and witnessed a notable rise in its delegate participation with every edition.
This year however, the Global summit was organized at Ahmadabad that was attended by PM himself, thereby emphasizing that India is serious about exploiting its huge potential.
In recent years there is an improvement in the exports and also the awareness that we can play a big role. In April 2022, the Prime Minister of India, Mr. Narendra Modi, laid the foundation stone for the WHO Global Centre for Traditional Medicine (GCTM) in Jamnagar, Gujarat. The centre is a collaborative project of the Ministry of Ayush of India and the World Health Organization (WHO) and is the only centre for traditional medicine in the world.
Although, India has a huge potential; to be a major contributor but, as of now we are a marginal player in 62 billion dollar market of TMs and we have a long way to go. It is to be seen as to how the Govt of India overcomes the numerous challenges as enumerated above, .
Traditional Chinese medicine (TCM), system, that aims to prevent or heal disease by maintaining or restoring yinyang balance. Is also one of the world’s oldest medical systems and quite popular. Acupuncture and Chinese herbal remedies date back at least 2,200 years, China’s contribution in this trade is approx 6 billion dollars.
Last but not the least, The Indian medicine system can succeed and become a major contributor in the world market only when these crooked manufacturers are not allowed to resort to Emotional selling and are made to adhere to laid down rules and standardization procedures ; collection of raw material, manufacturing etc.