Evaluation of drug standards, quality control, and trade in medicinal plants

Shailaja Chandra; Dasalukuntey Bhimarao Anantha Narayana

doi:10.4103/jras.jras_151_22

ONE NATION, ONE HEALTH SYSTEM - SPECIAL ISSUE

Year : 2023 | Volume : 7 | Issue : 1 | Page : 13-20

Evaluation of drug standards, quality control, and trade in medicinal plants

Shailaja Chandra¹, Dasalukuntey Bhimarao Anantha Narayana²
¹ Former Secretary, ISM&H (AYUSH), Ministry of Health and Family Welfare, Government of India, New Delhi, India
² Chief Scientific Officer, Ayurvidye Trust Bengaluru and Chairman, Herbals Committee of Indian Pharmacopeia Commission, Ministry of Health &Family Welfare, Government of India, New Delhi, India

Date of Submission	02-Oct-2022
Date of Acceptance	10-Nov-2022
Date of Web Publication	08-Dec-2022

Correspondence Address:
Ms. Shailaja Chandra
Former Secretary ISM&H (AYUSH), Ministry of Health and Family Welfare, Government of India, New Delhi
India

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/jras.jras_151_22

Abstract

This article is about the importance of medicinal plants in the manufacture of Ayush formulations or exported as raw drugs. Granting a license to manufacture, conducting quality control tests, and enforcing the legal provisions of the Drugs & Cosmetics (D&C) Act 1940 are the responsibilities of the relevant statutory regulatory bodies. The main stakeholders responsible for ensuring the products' quality, safety, and effectiveness are licensed manufacturers who have to follow the standards prescribed under the statutory regulations. The widespread interest in Ayurvedic drugs and other plant-based products led to this appraisal of the achievements and challenges of the regulatory bodies and those responsible for accelerating the organised cultivation of medicinal plants for domestic use and for export.

Keywords: Ayush drugs, export, medicinal plants, quality

How to cite this article:
Chandra S, Anantha Narayana DB. Evaluation of drug standards, quality control, and trade in medicinal plants. J Res Ayurvedic Sci 2023;7:13-20

How to cite this URL:
Chandra S, Anantha Narayana DB. Evaluation of drug standards, quality control, and trade in medicinal plants. J Res Ayurvedic Sci [serial online] 2023 [cited 2023 Mar 27];7:13-20. Available from: http://www.jrasccras.com/text.asp?2023/7/1/13/362942

The responsibility for the first part of the article is shared by both the authors, whereas the first author takes sole responsibility for the second part of the article.

Introduction

The four requirements to produce quality items are: (i) the use of quality medicinal plants as raw materials (whether through cultivation or collection from uncultivated sources), (ii) adherence by manufacturers to the prescribed pharmacopeial and regulatory standards, (iii) proper testing, licensing, and enforcement of quality standards, and (iv) ethical marketing to provide proper information to the most crucial beneficiary of all these efforts—the buyer. On these four pillars rests the integrity and trustworthiness of Ayurvedic drugs sold in India and herbs destined for export covered in Part-I.

The latter part of this article (Part II) deals with the status of medicinal plant export and the need to accelerate the production of quality medicinal plants in high demand abroad. Most of the medicinal plants being exported are used extensively in Ayurvedic formulations, herb-based toiletries and cosmetics. Given the continued use of these plants over centuries, this should become India's unique selling proposition. But unless the range of stakeholders in this segment works collaboratively, the goal of One Nation, One Health may remain diffused.

Part I: Drug Standards and Quality Control

Historical progress in Ayurvedic drug manufacturing

During the pre-Independence era, the Vaidyas and hakims had advocated repositioning the traditional systems of medicine to confront the advent of western medicine. Post-Independence, there was a growing support for Indian medicine. Still, almost every committee set up by the government recommended that the systems reprove themselves by meeting the benchmarks for scientific research, as prescribed for modern medicine.^[1] Bulk manufacture of Ayurvedic drugs only started in the mid-19th century as a hegemonic response to the spread of western medicine. The use of modern machinery enabled Ayurvedic drug manufacturers to move into factory-based production while still observing the original principles listed in the Ayurvedic Granthas (authoritative texts). The late 19th century witnessed the establishment of manufacturing units in Bombay (Shree Dhootpapeshwar, 1888), Kottakal (Arya Vaidya Sala, 1901), Coimbatore (Arya Vaidya Pharmacy, 1902), and Calcutta (Kalapataru Ayurvedic Works, 1884), and these became the pioneers that transformed Ayurveda into a new world of large-scale production and marketing while retaining the classical mode of preparation. By the latter part of the last century, branded patent and proprietary (P&P) medicine increasingly replaced classical formulations. Once factory-based manufacturing took root, the market dynamics changed, and the need for state regulation, laboratory testing, and the adoption of scientific methods for identifying and formulating quality drugs became necessary. Regulating the manufacture and sale of Ayurveda, Siddha and Unani (ASU) systems of medicine was no longer an option but a legal necessity.

Milestones in establishing a legal framework for the manufacture of Ayurvedic drugs

The history of past achievements and current developments shows that the progress has been intermittent, and in respect of pharmacopoeial work the momentum has slowed down in the last few years [Table 1].

Table 1: Milestones in establishing a leg al framework for Ayush drugs

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The D&C Act 1940 was amended in 1964 to include chapter IVA with regulations specifically defining the manufacture and sale of Ayurvedic products. Ensuring the use of the right medicinal plants of proper quality was fundamental to achieving this. The Ayurvedic formularies and pharmacopeias were declared as legal benchmarks for determining the ingredients’ quality and the methodology used for the preparation of formulations. A good pharmacopeia being a non-negotiable benchmark for stakeholders, the need for monographs was essential to assess the quality and conformity to the standards of identity (ensuring the authenticity of the drug), purity (for testing positive/negative contaminants, namely, heavy metals and the presence of biological contaminants such as fungus, bacteria, aflatoxins), and strength (the quantification of active constituents).

The first edition of the Ayurvedic Formulary of India (AFI), Part I, was published in 1978 and was the first official document on Ayurvedic medicine prepared by Ayurvedic Pharmacopoeia Committee (APC). This document urged the manufacturers to follow the formulation and processes prescribed. Introducing it in the First Schedule of the D&C Act 1940 gave the compendium legal status.

Since then, AFI has published standards for 985 Ayurvedic formulations (in Parts I–III). The first pharmacopoeial standard publication with monographs for 80 raw drugs of plant origin used in Ayurveda was published in 1986 as the Ayurvedic Pharmacopoeia of India Part I, Vol. I.

The need to follow good manufacturing practices (GMP) was realized very late. These guidelines were first notified in June 2000 when they became mandatory for new ASU drug manufacturing units. Although the acceptance was very slow for many years, according to the present data given by Central Council of Research in Ayurvedic Sciences (CCRAS), 91.67% of the manufacturers are GMP compliant. This is a good development. But although GMP is necessary, it does not confirm that the drugs manufactured are safe and effective. Moreover, granting a GMP certificate has several loopholes that must be plugged in to ensure effective compliance.

Rule 158(B) of the D&C Act was amended vide GSR 663 (E), August 10, 2010, mandating the need for indicating the requisite supportive documents/dossier (e.g., proof of published literature, safety studies, proof of effectiveness, etc.) applicable to various categories of drugs covered under patent or proprietary medicine as defined under Section 3(h) of the D&C Act, 1940. Under Rule 161(B) (revised vide GSR 789(E) dated August 12, 2016), a mandatory requirement was introduced to submit the stability data according to the guidelines published in Ayurvedic Pharmacopoeia of India (API) Part I, Vol. VIII, for ASU patent or proprietary medicine.

Accelerated shelf-life studies for fixing product shelf life were incorporated under Rule 161(B) in June 2019.^[2],[3] It was aimed at promoting actual shelf-life studies of drugs instead of relying on textual references and was required to comply with labeling standards.

Rule 161(B) of the D&C Act has been modified vide notification issued in August 2016.^[2],[3] This was the second notification after 2009 indicating the shelf life of Ayush drugs has been made mandatory to be imprinted on the labels.^[3] This change alone has been a milestone in the history of Ayush drug manufacturing by enabling the consumer to check whether the drug has expired.

Food Safety and Standards (Ayurveda Aahar) Regulations, 2021, were issued by Food Safety Standards Authority of India (FSSAI). This is a very progressive step toward ensuring the marketing of Ayurveda dietary products.^[4]

Recently on July 8, 2022, the Health Ministry proposed to include a new chapter V—Provisions relating to Ayurveda, Siddha, SowaRigpa, Unani and Homoeopathic drugs and to constitute an Ayush Drugs Technical Advisory Board and an Ayush Drugs Consultative Committee to advise the central government and the state governments on technical matters pertaining to drugs, medical devices and cosmetics, and other functions assigned to it. (This is still a Bill as it awaits public objections and comments.)

Discussion

The foreseeable positive impact of collaboration between PCIM&H and IP

To achieve the goal of One Nation, One Health there cannot be two pharmacopeial standards in one country. This dichotomy should have been addressed several years ago. Very recently, on August 30, 2022, the Ministry of Ayush entered a “One Herb, One Standard” memorandum of understanding (MoU) between the Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM&H) (Ministry of Ayush) and the Indian Pharmacopoeia (IP) Commission with the primary objective of developing harmonized herbal drug standards. If this is pursued vigorously, the need to have two sets of monographs for the same Indian herb would be overcome because the monographs in the API developed over decades are not in line with globally acceptable monographs and need updating for botanical identity confirmation, testing for analytical or biomarker compounds, testing for the chromatographic profile of significant groups of compounds, contaminant tests, and providing photo documentation to guide the analyst. Without botanical and phytochemical reference standards and a DNA barcode test for final confirmation, checks to detect substitutes and adulterants cannot be made.^[5] These are integral to the IP. The monographs in the IP meet globally acceptable scientific evaluation standards, and many IP monographs for raw herbs or processed herbs have been adopted and included in the British Pharmacopoeia, European Pharmacopoeia, and the United States Pharmacopoeia. If PCIM&H follows the IP standards for single herbs, it will upgrade the essential quality of monographs.

Related requirements that are essential

The Ayurvedic Pharmacopoeia Part II (Formulations) Vols. I–IV published 202 monographs on formulations. This is just a drop in the ocean regarding the number of classical medicines being marketed. For example, a monograph on Giloy Ghanvati is yet to be included in API Part II (Formulations). The drug had been extensively recommended during the pandemic because of its exceptional pharmacological properties. A dossier was published in 2022 “to showcase and discuss the therapeutic potential and clarify safety issues of Tinospora cordifolia” and “answer panic in the mind of the general public and practitioners of Ayurveda (in publications) raising safety concerns about the liver toxicity potential of Guduchi.”^[6] A monograph is however needed.

Bhasmas: The D&C Act 1940 does not insist on the processing details in the case of Bhasmas, with the result that none of the labels exhibit these details. One can find several methods for preparing a single Bhasma in the Ayurvedic texts. Hence, it is necessary to specify the method used to manufacture a particular formulation. As there have been serious concerns regarding the presence of heavy metals and their related toxicity in the case of Bhasmas, the mention of the heavy metal content should appear on the drug container labels. The development of monographs for Bhasmas needs to be taken up by the PCIM&H and APC.

Challenges, concerns, and the way forward

With the new thrust given to evolving better pharmacopeial standards, there is an urgent need to provide pharmacognosists, botanists, Rasa Shastra and Dravya-guna experts, phytochemists, analytical chemists, and instrumentation specialists to enable the drafting and editing of the monographs to be done expeditiously. Although the Ministry of Ayush stands for the development and propagation of Ayush, it must select scientists and subject experts through Union Public Services Commission (UPSC)or by seeking the help of academics from central universities. Adequate budget provisions should be made specifically for enabling core research. The involvement of high-quality, privately funded research and analytical laboratories working around testing herbs would bolster this effort instead of creating posts in the government, which takes a long time. CCRAS and its peripheral units/institutions spread across the country can collect samples of raw herbs, authenticate them, and provide the same to the approved laboratories for monograph development.

Over the last couple of decades, the Indian Council of Medical Research has published 18 volumes providing monographs for many raw herbs already developed by leading laboratories across the country. Using the work already done would avoid duplication. All it needs is to conduct a quick review and include a reference to those monographs in the D&C Act’s schedule. This is fundamental to achieving One Nation, One Health.

Most Ayurvedic drug manufacturers lack the financial capacity and incentive to invest in specialized equipment to test quality. Government should either establish new laboratories or outsource and levy charges for using private labs or recognize existing regional laboratories to test for heavy metals levels, pesticide residues, and microbial quality. The infrastructure available to laboratories under the Ministry of Science and Technology, including the biotechnology laboratories, can be requested or paid to develop DNA barcode tests and specifications for at least 100 commonly used herbs as an alternative test to confirm botanical identity. Many overseas buyers of herbs are demanding this as a precondition for purchase.

Under the central sector scheme of M/o Ayush, that is, Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) has been implemented to augment the quality of Ayush drugs along with a provision for funding infrastructure and technology upgradation to acquire National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation and to meet recurring costs of chemicals and reagents, consumables, and technical human resources, etc., in the states/union territories, Government ASU&H Drug Testing Laboratories, and the laboratories of the Research Council. This is expected to help upgrade Ayush drug testing laboratories.^[7]

Currently, licenses for manufactured ASU medicines, whether classical or P&P preparations, are granted by the State Licensing Authorities where the manufacturing units are situated. There was no standard format for application for the grant of these licenses leading to enormous variation in the information and data required to be attached to the application while seeking a license. The process followed for the grant of licenses was also not uniform, resulting in delays and unnecessary paperwork. The Ministry of Ayush vides Gazette notification no. GSR 716 (E) dated October 1, 2021, amended Rule no. 153 D&C Act, 1940, and Rules 1945, thereunder, whereby the process of licensing of ASU drugs have been simplified. The applicants seeking licenses for ASU medicines can now apply through an E-Aushadhi portal (www.e-aushadhi.gov.in) in the prescribed format.^[8] This Gazette notification also amended Rule 156 of the D&C Act, 1940, and Rules 1945, thereunder and revised the validity of the product license in perpetuity. States such as Gujarat, Haryana, and Himachal Pradesh have already adopted the e-Aushadhi online portal. Still, some states such as Tamil Nadu, Madhya Pradesh, and Punjab are yet to put the mechanism into place. Even the website in the gazette notification dated June 30, 2021 is not accessible in the first week of September 2022. Since the drugs move in interstate commerce, delay in adopting the new provisions should be met if needed by restricting interstate commerce in the interest of public safety.

At least 5% of survey samples, if picked up by Ayush drugs inspectors or by using qualified people working under statutory supervision and having the survey samples tested, may make the bulk of the manufacturers (except the top players who may be already doing it) more accountable. Were the examples of deficiencies found in survey samples to be taken up for intensive scrutiny, it might make the noncompliant manufacturers pay greater heed to quality. GMP must also be backed by good agricultural practices GLP, and random checks for compliance need to be organized.

Once formed, the new Drugs Technical Advisory Board (DTAB) for Ayush needs to insist that the states pay attention to adherence to quality parameters, as both are essential for consumer protection and global acceptance. There should be zero tolerance for the circumvention of the rules and regulations.

Status of quality certification

The Certification Scheme operated by the Quality Council of India since 2009 is a voluntary certification scheme for ASU&H products having two levels: (i) The Ayush Standard Mark is based on GMP for Ayurvedic, Siddha, and Unani medicines (Schedule T) under the Drugs and Cosmetic Rules, 1945, and (ii) Ayush Premium Mark based on World Health Organisation (WHO)'s GMP guidelines covering herbal medicines.^[9],[10] Currently, 83 units have received either of the Ayush marks for their products. This is a good step toward ensuring the quality of Ayush products, but considering there are some 8000 manufacturers, the off-take of the quality mark seems to have been availed of only by the top segment of manufacturers.

Part II: Cultivation and Export of Medicinal Plants and the Roles of NMPB and SHEFEXIL

An absence of clarity about D&C Act licensing vs. FSSAI licensing pervades the growth of the medicinal plant sector, as many of the plants have been widely used in Ayurveda but are increasingly being used for manufacturing food supplements and nutraceuticals. Quite independent of the Ayurvedic Drug dealers and manufacturers, several other organisations are exporting parts of plants as raw drugs, herbal extracts, or herbal food supplements in response to international demand. These plant parts do not go as Ayurvedic raw drugs although some plants are common to those used in making Ayurvedic formulations. The Shellac and Forests Produce Export Promotion Council (SHEFEXIL) under the Ministry of Commerce, facilitates such export. Although the exporters use several plants common to Ayurveda, the produce is exported as raw drugs, herbal extracts, or herbal food supplements. India’s domestic consumption of herbs is also massive. For example, the production of Aamla (Gooseberry) was 1206 MT in FY 2021–22, whereas the export was 330.66 MT, including processed items such as pickles and candy.^[11],[12] The planned cultivation of herbs is still nascent and is not readily taken up by the farming community. The herbs continue to be mainly collected from the forests. The need as a country—not only the Ayush sector—is to accelerate planned cultivation and to market the products with value addition on a global scale.

The National Medicinal Plant Board (NMPB) was set up by the erstwhile Department of ISM and H in 2000. The primary mandate of NMPB is to develop an appropriate mechanism for coordination between various ministries/departments/organizations to implement support policies/programs for overall (conservation, cultivation, trade, and export) growth of the medicinal plant sector at the central/state and international levels. If anything, the mandate has been widened.

NMPB’s current mandate

In response to a questionnaire seeking information about its current mandate and outreach the reply given was “NMPB focuses on in-situ and ex-situ conservation and augmenting local medicinal plants and aromatic species of medical significance. The NMPB promotes research and development, capacity building through training, and raising awareness through promotional activities like creating Home/School herbal gardens. Development of Good Agricultural and Collection Practices (GACPs), development of monographs laying down standards of quality, safety, and efficacy, development of agro-techniques and credible institutional mechanisms for certification of quality of raw drugs, seeds, and planting material is another mandate of NMPB, working at National, regional as well as State level. Each state has a State Medicinal Plants Board (SMPB) while there are seven Regional Cum Facilitation Centres (RCFCs) to co-ordinate between the SMPBs and NMPB.”

However, although details were sought, no data were provided on plants under cultivation by region and by hubs. Data on successful cultivation and evaluations undertaken were also not provided, and nor do these appear to be in any publication. The quantity of production through cultivation, as supported by NMPB, was not provided except for the net area under the cultivation of medicinal plants, which was stated to be an area of 56,305 hectares (throughout the country) from the financial years 2015–16 to 2020–21. This appears to be very small, considering the huge demand for medicinal plants, whether by the Ayush industry or for export. The standards for Ayurvedic medicine are governed by the API scheduled under the D&C Act, whereas the standards for botanicals/nutraceuticals come under the standards set by FSSAI. Regarding the export of raw drugs and extracts, according to SHEFEXIL, there are some 200 companies that actively export or are engaged in the production of nutraceutical products and botanical extracts. Standardized botanical extracts are exported as ingredients for the nutraceutical, pharmaceutical, food, and perfumery sectors. Most importers are in the developed countries such as the United States, European Union, Japan, Korea, etc. The importers use these ingredients to manufacture products that are eventually sold as end-use capsules and tablets, among other dosage forms, termed as dietary supplements, food supplements, or nutraceuticals, with each country having its nomenclature and terminology. The global nutraceuticals’ market is at $413bn and is forecast to grow to $650 by 2030.^[13] Of this, India accounts for only $1.5 billion, which is less than 0.40% of the total export.

Unless India has a clear idea of what the importing countries are seeking and there is a plan to grow the produce in identified climatic zones by district, exports will remain just incremental. Presently, it does not appear that NMPB has made any such plans for medicinal plants or by Agriculture Ministry for cultivable medicinal plants with huge export potential. SHEFEXIL is a facilitator, not a grower or seller. All export-driven efforts are privately driven, and there is no information about the source of the medicinal plants. Seen from the point of view of export potential, the fact that most of the plants have been used in Ayurveda for millennia should be used to further India’s USP and increase the marketability of the items—not to draw a wedge between Ayurvedic plants and the rest. Moreover, unless there is the value added when the plants are exported, the country will not benefit. The fact that the items have been used in Ayurveda and Indian kitchens for centuries will not cut any ice unless India acquires the technology to boost the production of medicinal plant-based botanicals of Indian origin for the Indian export market. If Ayurvedic drugs are not accepted as medicine, they will be accepted as food supplements. A regular demand and supply analysis, accompanied by planned cultivation by region, is a must for this to flourish and grow exponentially.

This is the mandate that NMPB needs to follow with the support of vast agricultural networks that already exist.

The world of medicinal plants export

SHEFEXIL lists psyllium husk, senna, and zedovary (Curcuma species) plants with the highest demand. In 2019, the then Commerce Minister told the Lok Sabha that the export of medicinal herbs to China had increased from US $5.4 million in 2016–17 to US $13.4 million in 2018–19, making China one of the top five countries to which India majorly exports medicinal plants and plant products. Apart from China, India was reported to be a prominent exporter to countries such as the United States of America (US $102.89), Germany (US $34.07), and Vietnam (US $26.76). In all, India exports medicinal herbs to 164 countries.^[14] Over the last 10 years leading Indian exporters have invested in R&D and patented unique formulations of nutraceuticals that utilize botanical extracts. Ashwagandha, widely used in Ayurveda, has seen an upsurge as a dietary supplement, with sales increasing by over 185%. According to the Nutrition Business Journal of the United States, herbal dietary supplement sales in the United States are reported to have exceeded $11.2 billion in 2020.^[15],[16]

Absence of harmonized system codes—An intractable problem

For over 20 years, the allocation of harmonized system (HS) codes has been stated to be the main obstacle preventing the export of Ayurvedic drugs. All nutraceutical products are presently being exported under Ch 1302 HS code and extracts. Most of these are under the residuary “others” category of HS code 13021919. SHEFEXIL has proposed that a list of 18 products be considered for creating New Tariff Lines in the Customs Tariff Act, 1975, which are currently being exported under “Others.” These include 1. Emblica officinalis (Amla extracts), 2. Bacopa monnieri (Brahmi), 3. Berberis aristata, 4. Boswellia serrata, 5. Capsicum annuum (Paprika), 6. Coleus forskohlii, 7. Glycyrrhiza glabra, 8. Ocimum sanctum (Tulsi), 9. Tagetes erecta (Marigold), 10. Phaseolus vulgaris (Rajma), 11. Piper nigrum (black pepper), 12. Pterocarpus marsupium, 13. Salacia reticulata, 14. Terminalia bellirica, 15. Curcuma longa, 16. Withania somnifera (Ashwagandha), 17. Zingiber officinale, and 18. Punica granatum. Many of these items are also among Ayurvedic plants, but that is not a consideration for importing countries.

Apart from the tangle over HS codes, another obstacle is that unless the annual value of export of each plant is higher than Rs. 100 crores, it cannot get an HS code limit set by the Central Board of Excise and Customs (CBIC) for the allocation of Tariff Lines. Without individual HS codes, no analysis of demand and supply, which forms the basis for sustainable cultivation, can be made. Given the immense export potential of these products (estimated at over 3 USD billion), there is a case for grant of a 3–5 years relaxation of the threshold limit of Rs. 100 crores, which will enable the assignment of tariff lines to monitor and promote both planned cultivation and export. This need is critical but will not get traction without a concerted effort to convince CBIC because though the potential looks comparatively small compared to, say, jewelry export, the latent scope for India to become a world leader is immense.

Since many, if not all, plants are used in Ayurvedic formulations, NMPB must work in tandem by focusing on the needs of domestic Ayurvedic drug manufacturers and also facilitating the cultivation for export. Like the Coffee Board set up under the Coffee Act VII of 1942 and the Spices Board set up under the Spices Board Act 1986, NMPB needs to be converted into a commercially run company with responsibility for export promotion. In the short term, it should collaborate with SHEFEXIL. The aim should be to run the Board to earn profits by meeting the demand and supply of medicinal plants. The Board is presently run as an arm of the Ministry of Ayush, beset by the usual drawbacks like low budgets, too many vacancies, and the absence of continuity in the top management. Unless it is given statutory status and empowered to function on commercial lines, it will function as a welfare arm for promoting small cultivators, which will not fulfill its mandate. If NMPB grows into a vibrant commercial entity, it can also be tasked with certification by outsourcing laboratory analysis, grading the plants, and accepting advance bookings to meet the demand for quality medicinal plants domestically and internationally. NMPB should develop Herbal Drug parks or consortiums in defined geographical areas to make authentic raw materials readily available. This will stop the continuing dependence on unorganized mandies, which have been criticized repeatedly for nonadherence to proper storage standards and for stocking raw drugs in unhygienic conditions. Teaming up with SHEFEXIL, the knowledge and experience available to the Ministry of Commerce can be used to advantage.

Quality standards for Ayurvedic drugs, personal care products, and botanicals

According to an IMARC study,^[17] Ayurvedic manufacturers are either in the organized or unorganized sector in the proportion of 60% and 40%. But the items they produce are not all Ayurvedic medicine and include larger segments comprising Ayurvedic nutraceuticals and dietary supplements and personal care products including hair care, skin and oral care, and cosmetics. The Indian Ayurvedic products market is highly fragmented, with thousands of large and small players competing in terms of price and quality. The trend has also shifted to once purely Ayurvedic companies currently manufacturing both Ayurvedic drugs and health, wellness, and personal care products. These Ayurvedic cosmetics/toiletries are predominantly marketed as Ayurvedic medicine under an Ayurveda D&C Act license, often bypassing the provisions of various laws. One of such products shown in [Figure 1] is being marketed as Ayurvedic medicine but falls in the category of misbranded drugs because of noncompliance to labeling provisions as defined in Rule 161 of the D&C Act. The product’s license regulation selection appears flexible, so the consumer must be aware of what to look for when buying products.

Figure 1: Misbranded marketed Ayurvedic medicine

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Building consumer awareness

While substantial progress has been made in tightening and simplifying the licensing requirements for Ayurvedic drugs, the result does not seem to have equipped the average consumer to know what to look for when buying products claiming therapeutic benefit. Although Ayurvedic medicine ought to be prescribed only by a practitioner, most often, Ayurvedic drugs are procured by consumers over the counter and increasingly online. The consumer is unaware of product’s compliance with the prescribed standards, whether the primary ingredients and excipients are present, and whether the herbs are present in the quantities and strength prescribed.

Making the stockist and pharmacy/shop responsible

Because no prescription is needed to buy Ayurvedic medicine, the labels and product inserts build accountability and act as a bridge to educate the consumer. To ensure that only adequately labeled products are stocked, every stockist or chemist/shopkeeper engaged in the retail sale of ASU medicine making therapeutic claims needs to be registered and made responsible for only stocking ASU products that fulfill the quality certification requirements for herbs—minerals, and metal-based products, in particular, and to only sell items that display the API/PCIM or IP label. Stocking and selling misbranded items with improper labels displaying unverifiable documentation should be treated as unethical. Also, unless consumers can understand the advantages of looking for quality marks and how to distinguish between them, the objectives of an excellent consumer-friendly quality mark scheme have been lost.

Advertisements and other promotional efforts in mass media (print, TV, and online)

These should be closely monitored, and making therapeutic claims in the media should lead to action under the Drugs and Magic Remedies (objectionable advertisements) Act 1955. Recently, the Ministry of Ayush has become proactive in such cases, but the work done is limited to the size of the problem. Data—not names—of the action taken should be shared to build public confidence.^[18]

Pharmacovigilance

This is another pillar that needs to be strengthened. Although a lot has changed in the last 8 years when only a draft was available, there is presently a framework available with the establishment of the National Pharmacovigilance Center at the All India Institute of Ayurveda, five intermediate centers and 42 peripheral pharmacovigilance centers. The need is to educate physicians about invariably reporting adverse drugs reporting to the in-pharmacovigilance centers. Publishing state-wise data on the reports generated and action taken would only strengthen public confidence and alert manufacturers.

Conclusions

The authors have written this article to use an opportunity presented by the establishment of a new Ayush Drugs Technical Advisory Board and an Ayush Drugs Consultative Committee to highlight both the achievements and challenges ahead in confronting two aspects of quality control-laying internationally acceptable standards and enhancing export potential of value-added products derived from medicinal plants. Critical gaps that must be filled have been highlighted, and a slew of recommendations made for improving the quality control of Ayurvedic drugs and the cultivation of medicinal plants to benefit Indian consumers and accelerate export earnings. It is hoped that the contribution will be acted upon in the best interest of the country and the unique history embedded in its traditions and culture.

Acknowledgments

The authors thank the officers in the CCRAS under the leadership of the Director General, Prof. Rabinarayan Acharya, for helping update the article’s pharmacopoeial data, so also Dr. Chinmay Rath, Research Officer (Botany) in NMPB, for furnishing available data. Key officers in the Ministry of Commerce and DGFT provided access to the published data, which the first author would not have located without their support. The author is also grateful to Dr. Debjani Roy, Executive Director of SHEFEXIL, for sharing published data on the import–export of medicinal plants. The thoughtful insights of Dr. Rajeev Sharma, Former Director of PLIM&H, must be acknowledged. The first author is appreciative and grateful to Dr. Piyush Chaudhary, Assistant Professor, Department of Rasa Shastra, MSM Institute of Ayurveda, Bhagat Phool Singh Mahila Vishwavidyalaya, Haryana, for having helped to edit and reference the article.

Financial support and sponsorship

Nil.

Conflicts of interest

CCRAS had invited the authors to write an article, and the authors declare no conflicts of interest.

References

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