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| MANN KI BAAT - SPL. ISSUE - SECTION 6: INDUSTRY & ACADEMIA COLLABORATION |
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| Year : 2023 | Volume
: 7
| Issue : 5 | Page : 73-81 |
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Enhancing Quality of Ayush Products – Strategies and Efforts of the Ministry of Ayush and Ayush Industry
Chandra Kant Katiyar1, Anirban Kr Chakrabarty2, Sunil Kumar Dubey2, Pradeep Kumar Pandey3, Manash Tumulu3, Avinash Narwaria2
1 Emami Ltd, Kolkata, India
2 R&D Healthcare Division, Emami Ltd, Belgharia, Kolkata, India
3 R&D Packaging Division, Emami Ltd, Belgharia, Kolkata, India
| Date of Submission | 13-Apr-2023 |
| Date of Acceptance | 18-Apr-2023 |
| Date of Web Publication | 28-Apr-2023 |
Correspondence Address:
Chandra Kant Katiyar
Emami Ltd, 687, Anandapur, EM Bypass, Kolkata 700107
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_92_23
How to cite this article:
Katiyar CK, Chakrabarty AK, Dubey SK, Pandey PK, Tumulu M, Narwaria A. Enhancing Quality of Ayush Products – Strategies and Efforts of the Ministry of Ayush and Ayush Industry. J Res Ayurvedic Sci 2023;7, Suppl S1:73-81 |
How to cite this URL:
Katiyar CK, Chakrabarty AK, Dubey SK, Pandey PK, Tumulu M, Narwaria A. Enhancing Quality of Ayush Products – Strategies and Efforts of the Ministry of Ayush and Ayush Industry. J Res Ayurvedic Sci [serial online] 2023 [cited 2023 Jun 8];7, Suppl S1:73-81. Available from: http://www.jrasccras.com/text.asp?2023/7/5/73/374515 |
It is time to ensure that our products meet global standards. Whatever is the global best; we should make it in India and prove it. For that, our entrepreneur friends have to come forward. Startups too, have to come forth.
Hon’ble Prime Minister of India, Shri Narendra Modi
Mann Ki Baat- 27 Dec, 2020
Ayush has received tremendous attention in the recent past, and the Government of India has vigorously promoted it both in India and abroad along with Yoga. The honorable Prime Minister of India, right from 2014, has most of the time touched upon the benefit of Ayush for society. Along with increasing popularity and focus, the quality of Ayush products also received desired attention from the government and the industry to keep the system relevant for its global positioning. Quality is a critical parameter in product evaluation for ensuring safety, efficacy, and batch-to-batch reproducibility. It thus plays a significant role in determining a product’s acceptance across the market. The Government of India, in association with several industries, has been on an ongoing mission to set quality as a benchmark for every product under the umbrella of Ayush. This article covers the strategies followed by the Ayush ministry and the self-initiatives of the industry for enhancing the quality of Ayush products.
| Introduction | |  |
Our honorable Prime Minister, Shri Narendra Modi, has emphasized Yoga, wellness, and the importance of Ayush for promoting holistic health in our country by sharing his “Mann Ki Baat” since 2014. To cover a larger audience, he has used “Mann Ki Baat” as a platform to share his thoughts. He has tried to instill his messages amongst fellow citizens with empathy through this novel initiative. The Ministry of Ayush, Government of India, has been continuously working towards strengthening all the Ayush systems to bring forth increased awareness and improve international acceptance of goods, services, and products [1]. This will ultimately facilitate a rise in stakeholders’ interests and foster opportunities for sustainable growth of the AYUSH industry [2],[3]. The foremost requirement for attaining the above is ensuring ‘quality’ at each step. AYUSH industry has been performing well over the last decade; as per the Research and Information System Report 2021: AYUSH Sector in India: Prospects and Challenges, the growth rate of the total output of the AYUSH industry has outperformed other industries such as Pharmaceuticals, Food and Beverages and Chemical/Petroleum industries. [4],[5]. The current turnover of the AYUSH industry is US$ 18.1 billion. It has grown by 17% during 2014-2020, demonstrating tremendous potential in the AYUSH sector [6].
Similarly, during the 87th episode of Mann Ki Baat, Hon.PM addressed that the market of the Ayush Industry is increasing continuously. Six years ago, the market for medicines related to Ayurveda was around 22 thousand crores. Today, the Ayush Manufacturing Industry is reaching around one lakh forty thousand crore rupees; the possibilities are increasing continuously in this sector. In the start-up world, too, AYUSH is becoming a subject of attraction.
The quality of any AYUSH product is thus assessed through the quality of raw materials in process control, processing, packaging, finished product, and its distribution in the market [3].
The Ministry of Ayush has taken several measures to implement ‘quality’ as a crucial criterion while developing AYUSH-based products which abide by the GMP guidelines to generate trust and increase awareness regarding the application of various ancient knowledge-based approaches that promote health and well-being across different parts of India [1],[7]. The AYUSH ministry also collaborated with World Health Organization (WHO) to deliver the same globally [8]. The article covers the major initiatives taken by the Ministry of Ayush, the Government of India, and the industry to ensure the quality of Ayush products.
| 1. Initiatives taken by the Ministry of Ayush, Government of India | | |
The continuous strive for the growth and upliftment of Ayush products has been a primary focus of the Ministry. The significant initiatives are mentioned below and as mentioned in [Figure 1]: | Fig 1: Summary of the initiatives taken by the Ministry of Ayush in the development and assurance of Quality Products
Click here to view |
- 1.1 Development and implementation of Good Manufacturing Practices (GMP) Schedule T and WHO-GMP guidelines for Ayush drugs [9],[10].
- 1.2 Certification of Ayush products-Ayush Mark(s) [11],[12].
- 1.3 Development of Ayurvedic, Unani, and Siddha Pharmacopeia and of “ONE HERB ONE STANDARD” [13],[14] through PCIM&H.
- 1.4 Setting up of National Medicinal Plant Board (NMPB) to develop sustainable cultivation strategies to ensure the availability of quality raw materials [15],[16].
- 1.5 Initiatives for post-marketing surveillance-Introduction of Ayush Pharmacovigilance[17].
1.1 Development and implementation of Good Manufacturing Practices (GMP) Schedule T and WHO-GMP guidelines for Ayush drugs
In India, State Governments regulate the licensing and quality control of ayurvedic medicines, whereas the legal provisions are devised or amended by the Central Government. Quality standards and Good Manufacturing Practices for Ayurvedic drugs are specified based on the Drugs and Cosmetics Rules, 1945, and Ayurvedic Pharmacopoeia and authoritative books listed in the first schedule of the Drugs and Cosmetics Act, 1940. For the global acceptance of products under the Ayush umbrella, the Ministry, in association with WHO, has implemented WHO GMP for providing Certificate of Pharmaceutical Products (CoPP)[18].
In India, Schedule T, under the Drugs and Cosmetics Act 1940, describes various regulations and requirements for manufacturing (as per GMP) of Ayurvedic, Siddha, and Unani (ASU) products. Schedule T specifies the requirements for hygienic conditions in the factories. Conforming to GMP standards is mandatory for all manufacturers of ASU products [19]. Implementing the GMP government ensures the total quality assurance of Ayush products.
Implementation of GMP generates trust in the products manufactured thereby. Moreover, it meets the requirements of several countries requiring GMP-manufactured products for successful imports. Thus, the incorporation of GMP enables manufacturers to export their products. WHO recommends COPP or Certificate of Pharmaceutical Products, and submission of it is mandatory for those countries that import goods or medicines [18]. The primary significance of COPP is that it indicates that the imported drug is of the relevant quality, safety, and efficacy standard. The Ayush marks can now be considered a basis for COPP for Ayurveda, Siddha, Unani, and Homeopathy products issued by the Drug Controller General [24].
| Heavy Metal Testing Made Mandatory for Herbal AYUSH products | | |
Saper et al. published an article in the Journal of American Medical Association in 2004 [23] claiming that fourteen out of seventy Ayurvedic products collected from the US market contained heavy metals. This article led to a series of actions by the then Department of AYUSH to impose stringent conditions on exports and make testing of heavy metals, mercury, arsenic, lead, and cadmium mandatory for all herbal Ayurvedic products not only for exports but for the domestic market also. Ayurvedic Pharmacopoeia recommended testing every product for heavy metals and pesticide residue, aflatoxin, and microbial load before releasing it to the market. This action of the then Department of AYUSH reinforced its focus on the quality and safety of products for consumers.
1.2 Certifications of Ayush products - Ayush Mark(s)
The Ministry of Ayush has undertaken an appreciable initiative for certifying the quality of Indian Traditional Medicines or Ayush products so that consumer confidence is increased and facilitates export [12]. For this purpose, the Department of Ayush signed MOU with the Quality Council of India (QCI) on 27th July 2009. QCI has drafted a Voluntary Certification Scheme for Ayush Products (VCSAP)[25] based on the certification criteria. Two certification marks are there for AYUSH products: the ‘AYUSH Standard Mark’ and ‘AYUSH Premium Mark.’ The basis of the AYUSH Standard Mark is compliance with domestic regulatory requirements, whereas AYUSH Premium Mark is based on the WHO GMP requirement and product requirements[25]. A significant contribution of AYUSH marks is providing a visual assessment and recognition tool for the quality of the product, which guides consumers to the product of the Ayurveda industry. These AYUSH marks are regarded as a symbol of trust nationally and internationally. At the same time, AYUSH Marks also helps to gain and increase the reputation and name of the industry in local, national, and international aspects [27].
1.3 Development of ASU Pharmacopeia
The quality of any product is dictated by many statutory bodies like-
- Ayurvedic Pharmacopeia of India
- Unani Pharmacopeia of India
- The Indian Pharmacopeia
- Bureau of Indian Standards
The standardization of Ayurvedic products is an essential factor driving scientific and industrial interests. Invention and selection of appropriate standardization processes for determining consistency, quality, and effectiveness are crucial. With time, changes have been made in the standardization techniques for herbs in the Ayurvedic Pharmacopoeia [28],[29].
The Ministry of Health and Family Welfare has published API for the traditional medicinal system, which significantly contributes to the quality assurance of these systems [30]. Since 2010, Pharmacopoeia Commission of Indian Medicine (PCIM), which is now, called Pharmacopoeia Commission of Indian Medicine and Homeopathy (PCIM&H), an apex body of the Ministry of Ayush, Government of India directs Ayurvedic Pharmacopoeia Committee (APC) for quality standards of ASU drugs [28].
In 2021, for further progression of Ayurveda and other Indian traditional medicine systems, PCIM&H has signed an agreement with American Herbal Pharmacopoeia, USA.
Challenges like multiple standards for a single herb in a day-to-day workflow have been a pain for the industry to manufacture ASU products. To address this issue, PCIM&H, and Indian Pharmacopoeia Commission, have signed an agreement for developing “One Herb, One Standard,” which clearly shows the sheer sensibility of the Government of India [14],[31],[32].
1.4 Setting up of National Medicinal Plant Board (NMPB) for the development of sustainable cultivation strategies to ensure the availability of quality raw material
Even though the primary resource of medicinal plants is woodlands, their decreasing rate due to anthropogenic pressure leads to the requirement for alternative sources of medicinal plants. Therefore, the only alternative means to generate more raw materials for herbal medicines could be cultivating medicinal plants on a large scale. The primary initiative taken by the Government of India in this context is establishing National Medicinal Plants Board (NMPB) on 24th November 2000 to coordinate every matter associated with medicinal plants and supporting policies and programs for developing trade, export, conservation, and cultivation as well [33]. [C1] The essential purpose of this government board is to encourage and promote the cultivation of medicinal herbs and management in a sustainable manner throughout the country so that the collection of herbs from wild sources can be reduced. In addition, NMPB has also encouraged research and development, developing and strengthening capacity through training and increasing awareness. By developing Good Agricultural and Collection Practices, agro-techniques, monographs prescribing standards of quality, safety, and efficacy, and credible instituting a mechanism for certification of quality of raw drugs, seed, or other planting material, NMPB encourages quality assurance and standardization of herbal drugs[33].
A Central Sector Scheme has been launched for the conservation, development, and sustainable management of medicinal plants to prevent destructive harvesting and the threat of extinction of herbal species, which ultimately would prevent the chances of mixing of substitutes or adulterants, which can affect the quality of the herbal preparations in terms of safety and efficacy [35]. This scheme aims to secure the sustained availability of quality herbs and herbal raw materials by in-situ and ex-situ conservation of endangered herb species that are considered crucial components of the AYUSH medicinal system.
1.5 Initiatives for post-marketing surveillance-Introduction of AYUSH pharmacovigilance
The Ministry of Ayush, along with the Institute for Post Graduate Teaching and Research in Ayurveda, Jamnagar, under the Central sector scheme for upgradation to the Centre of Excellence, launched National Pharmacovigilance Programme in 2008. From there onwards, this body is responsible for reviewing and analyzing the adverse drug reaction reports at different levels in ASU products[38]. This center has been shifted to the All India Institute of Ayurveda in New Delhi.
| 2. Initiatives by the Industry | | |
Going beyond regulatory requirements, the industry has come forward with innovative strategies and cutting-edge technologies across its diverse functional areas to maintain and promote ‘quality’ at every step of product development, manufacturing, and control. [Figure 2] depicts the initiatives taken by the industry, and they are mentioned below: | Fig 2: Schematic elucidation of Industrial Initiatives for establishing Quality Products at a glance.
Click here to view |
- 2.1 Adoption and incorporation of technology at various steps for manufacturing
- 2.2 Utilization of modern analytical techniques for quality control [39]
- 2.3 Use of the latest biotechnology tools for efficacy and safety determination
- 2.4 Development of platforms promoting digitization [40]
- 2.5 Shelf life Determination of ASU drugs [41]
- 2.6 Role of packaging in the quality of AYUSH drugs [42]
2.1 Adoption and incorporation of technology at various steps for manufacturing
Developing a product with quality as a top priority has always been challenging for industries. However, rapid advancement in technology and infrastructure has provided space for the industry to meet this challenge and deliver high-quality products. There are multiple aspects where the industries have put forward their contribution jointly with the AYUSH ministry to set a benchmark.
The regulatory guidelines and initiatives, a framework by the Ayush ministry, have provided a substantial guide to the industries for designing and manufacturing quality products. The first initiative that the industry has implemented is automation[43]. The elimination or minimization of manual interference in product sampling and quality checks has increased the workflow and rapidly minimized the chances of contamination with the overall upgradation of finished products. Automation at every step, from raw materials management with advanced tracking systems to post-sales vigilance of the finished products.
2.2 Utilization of modern analytical techniques for Quality Control
Industries have developed cutting-edge analytical technology, from raw herbs identification and sampling to quality checks of the finished products, including HPLC, HPTLC, GC-MS, LC-MS, thermal analytical methods like thermogravimetric analysis (TGA), differential thermal analysis (DTA), and differential scanning calorimetry (DSC) [29] that have been employed to study any physical or chemical changes in Ayurvedic medicinal products and also used to study pre-formulation or drug excipient compatibility. Near-infrared spectroscopy (IR Spectroscopy) technique has been used to quickly determine active components, species, unique medicinal formulae, in-process quality control, identification of counterfeit, and discrimination of geographical origins of the plant species. Thus, the identification and standardization of polyherbal Ayurvedic formulations by these technologies have also been a contribution by the industries [44]
The DNA fingerprinting technique, the latest gold standard tool, has been adopted by industries to eliminate the adulteration of plant species. This has been possible through the identification of intra-generic and intra-specific DNA markers of different Ayurvedic herbs [45]
Similarly, for bhasma, the Ayurvedic metallic preparations in which metal acts as a carrier for drug delivery, which is widely recommended for treating various chronic ailments, various high-end techniques like X-ray diffraction analysis (XRD), Atomic Force Microscopy (AFM), Transmission Electron Microscopy (TEM), Scanning Electron Microscopy (SEM), and Energy Dispersive Spectroscopy[47] have been employed for the estimation and characterization. Techniques like neutron activation analysis of calcium, iron, zinc, and mercury., confirmed the purity of bhasma. Recently, the utilization of microfluidic analytical devices for drug analysis has been adopted by industries. This technique offers several advantages, such as simplicity, low cost, rapid analysis, portability, and low reagent and sample consumption, thus creating a high-throughput platform with robust applicability.
2.3 Use of the latest biotechnology tools for efficacy and safety determination
The industry has developed modern biotechnological tools to validate the biological efficacies of Ayush products which have been a milestone achievement in the determination of the biological effects of the already-known traditional Ayurvedic herbs. Such signature initiatives involving the comprehensive amalgamation of chemistry and biology at various research-oriented Ayush pharmaceutical industries have set up a benchmark for developing quality products. [C2]
2.4 Development of platforms promoting digitization
One of the crucial aspects of quality product development is the document management system. Ayush ministry has given guidelines for proper documentation at each level of product development to ensure traceability and data authenticity. The industries have equally contributed to abiding by the guidelines in taking various constructive strategies. The introduction of an electronic documentation system has changed the scenario of tracking and channeling data in a highly organized manner. The electronic laboratory notebook (eLNB) system has been a boon to industries that helps in real-time documentation and data tracking. The unification of automated technologies for minimal human errors, high-throughput analytical techniques, and the latest IT infrastructure for proper documentation and storage has been the industry’s thrust areas to contribute and develop quality products.
2.5 Shelf-life determination of ASU drugs
A product’s shelf life is a crucial aspect of quality determination and relies on the packaging. The principal reason for stability testing is that the drug is safe and efficacious for patients. Moreover, it is a legal requirement that should be provided to the regulatory agencies to approve the drug or formulation. Stability studies ensure that the drug retains its mentioned functionality as long as it is available in the market.
2.6 Role of packaging in the quality of Ayush drugs
Packing of the product plays a crucial role in maintaining the stability of the product, thus, increasing and maintaining the shelf life of a product. Ayush products include churna or powder, tablets, capsules, and avaleha (electuary). Historically AYUSH products were delivered through Vaidya (Ayurvedic physician) in conventional packaging, i.e., packing a single dose in a paper wrap or glass bottles for liquid. As evolution took place through industrialization, many renowned companies started making Ayush products commercially. Packaging played a critical role in designing and delivering packaging formats suitable for production lines and providing the required shelf life to products. It helped the industry offer better consumer packaging, which can ease dosage/usage[49].
Majorly Ayush product contains natural herbs, and sometimes the formulation is highly sensitive to moisture, oxygen, heat, and light, which impacts the product’s texture, shelf-life, odor, and taste. Packaging has two primary functions, namely containment, and protection. Regarding containment, the package protects the product from being exposed to the environment; for protection, the product does not sustain any physical damage. The product and package must maintain a drug’s integrity and effectiveness from manufacturing to consumption. The foremost packaging requirement in this context is to protect the drug from chemical degradation. The bulk package used during manufacturing should not react with the drug being manufactured until the drug is consumed. It is one of the biggest tasks of the packaging material to maintain the shelf life of the product. The other protective functions of excellent packaging are sterility, re-closure, communication (via the label), compliance, tamper evidence, and temperature control. The technology of packaging a drug is a demanding and growing industry. There is a continuous requirement for the diverse area of package, design, development, and engineering. There is an ongoing change and re-alignment with developing newer technologies, drugs, and delivery systems[49].
Traditional Ayurvedic practices influence the packaging design for AYUSH products. The packaging is generally designed with earthy tones and natural textures to convey the natural and organic nature of the product. The packaging also includes images of herbs and plants to emphasize the natural ingredients used in the product. The packaging also includes information about the product, such as the ingredients used, the dosage, and the product’s benefits. To summarize, packaging plays a significant role in defining the quality of the AYUSH products by protecting and preserving the product, providing information, branding, ensuring compliance with regulations, enhancing the consumer’s perception of the product’s quality, and improving the overall experience of using AYUSH products. The packaging for AYUSH products in India is influenced by traditional Ayurvedic practices and is designed to be eco-friendly and biodegradable; some contemporary dosage forms of ASU products are shown in [Figure 3]. There is a trend toward using modern packaging materials like plastic and aluminum, but some companies are addressing environmental concerns by using biodegradable plastics and recyclable materials. The packaging design includes earthy tones, natural textures, and images of herbs and plants to convey the natural and organic nature of the product.
| Current status | | |
The Ayush ministry has implemented rule 161 B to mention the expiration date of Ayurvedic, Siddha, and Unani medicines and proposed for the shelf life of the Ayurvedic formulations as mentioned earlier after the issuance of the gazette notification by the Government of India on 20th October 2009, a modified draft notification of the same issued on 26th November 2005[19].
| Need gap analysis | | |
It has been well explained that packaging materials play a vital role in maintaining and increasing the shelf life of any product, but the guidelines available in AYUSH need to clearly mention the type of packaging required for the different types of formulations. To maintain the shelf life of different formulations mentioned in section 3 of rule 161-B, the ASU industries have to make their in-house guidelines regarding the packaging. The selection of a package often begins with determining the product’s physical and chemical characteristics, protective needs, and marketing requirements. The materials selected must have the following characteristics: They must protect the preparation from various hazards (physical, climatic, chemical, and biological), and they must not be reactive with the product. It must be compliant with the current Good Manufacturing Practices [C3] (cGMP) regulations), must not impart to the product tastes or odors, and must be nontoxic[19],[41].
| Initiatives on Packaging of ASU drugs | | |
To keep up with the advancements in the pharmaceutical industry, AYUSH industries are putting their efforts with the help of their Research and Development team to increase and maintain the stability and shelf life of their products following the guidelines. Due to the lack of packing guidelines, industries face multiple difficulties. Quality of packaging maintains the integrity of the Ayurvedic products during storage, shipment, and delivery. So, development in the packaging field correlates with the development of newer products. Software and technology services will significantly accelerate packaging design for Ayurvedic products. Cost and time-effective packaging technology need to be enhanced in Industry. Packaging should be patient-compliant as well, with proper labeling. Manufacturers involved in packaging for the self-drug administration process need to provide delivery systems that will simplify drug reconstitution before use, especially for nonprofessional caregivers. This will further increase the rate of launching a product in the market [50].
| 3.0 Summary | | |
Quality is one of the essential factors in harnessing global opportunities. During the recent pandemic of COVID, Ayush products have shown their potential to strengthen immunity and imparted a massive increase in overall wellness, which displays that quality plays a pivotal role in product efficacy. Moreover, adopting the latest technologies like DNA fingerprinting for raw materials evaluation, biological assays for ensuring efficacies, and mass spectroscopy for particle size analysis have pushed quality parameters high. In keeping up with the modern pharmaceutical industries, the Ayush Ministry has shown diligence in introducing post-marketing surveillance of their products by vigilance, also known as ‘AYUSH pharmacovigilance.’ We hope that all the quality augmentation steps by the Ministry of Ayush as well as the industry will make the dream of our honorable Prime Minister of taking Yoga and Ayurveda to a global pedestal would be realized in its harmony.
| 4.0 Future Perspective | | |
The pace of evolution for AYUSH across the globe has been remarkable past few years. This has been possible through the combined efforts of the Ministry of Ayush and the collaborating industries. The unanimous goal is to establish AYUSH products in India and the global markets. This has highlighted the ancient science of our motherland and the upliftment of traditional knowledge in the pan-scientific world. Thus, the industries have taken multiple approaches related to chemical, analytical, and manufacturing processes. Industrial influences have modernized the concept of packaging related to AYUSH products. Likewise, advancement in digitization and the latest technology adoption and implantation, abiding by the legal laws and guidelines will not only create a massive revolution in the AYUSH product markets but also create awareness and more acceptance. With the advent of artificial intelligence (AI) in the 21st century, the global markets have witnessed a tech boom, which the industries shall certainly explore to augment the quality standards of the products not only at the manufacturing level but also in their execution.
This crucial juncture calls for unified and synchronized efforts of the Ministry of Ayush and industries to take Ayush to newer heights to provide the global stature it deserves.
5.0 Acknowledgment
The authors acknowledge the contribution of the scientists at Emami Healthcare and Packaging R&D Divisions in Kolkata.
Financial support and sponsorship
Nil
Conflicts of interests
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
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