|ONE NATION, ONE HEALTH SYSTEM - SPECIAL ISSUE
|Year : 2023 | Volume
| Issue : 1 | Page : 56-58
Approach to seeking global recognition for Ayurvedic medicines
Anil Jauhri1, Deepika G Gunawant2
1 Ex-CEO, National Accreditation Board for Certification Bodies, New Delhi, India
2 Ayurveda and Wellness, Max Super Specialty Centre, New Delhi, India
|Date of Submission||01-Oct-2022|
|Date of Acceptance||03-Nov-2022|
|Date of Web Publication||08-Dec-2022|
Ex-CEO, NABCB, 485, Pocket C, Sarita Vihar, New Delhi 110076
Source of Support: None, Conflict of Interest: None
India is negotiating free trade agreements (FTAs) with several countries like the UK, Canada, European Union, and so on; one of the aims of these FTAs is more and easier access to Indian products. Ayurvedic medicines by themselves and especially given the COVID pandemic, which brought to the fore the importance of traditional medicines, represent one sector that needs to be taken up in these negotiations for access to trading partner markets. This paper is an attempt to present an approach to gain recognition of Ayurvedic medicines under FTAs and how it can facilitate easier access.
Keywords: Ayurveda, Global recognition, trade
|How to cite this article:|
Jauhri A, Gunawant DG. Approach to seeking global recognition for Ayurvedic medicines. J Res Ayurvedic Sci 2023;7:56-8
| Introduction|| |
As India has renewed its interest in free trade agreements and negotiations are on or likely to begin with the UK, Canada, European Union, and so on, one of the essential areas to look at is seeking easier access for our products in identified sectors in their markets by meeting their technical regulations.
In sectors in which our trading partners have imposed regulations (agrifood, pharmaceuticals, chemicals, electrical appliances, machinery safety, toys, medical devices, personal protective equipment, and so on), the Indian exporters need to meet these regulations and gain access to their market, which can be both time-consuming and expensive. Each overseas regulation specifies how an exporter from any country could get approved under the regulation and essentially now each exporter manages the compliance and approval on his own.
| Making Access Easier|| |
To make access easier, one route is to sign G-2-G (government-to-government) mutual recognition agreements (MRAs) with the trading partners so that an institutional mechanism to certify exports from India is accepted, doing away with the individual exporters having to demonstrate compliance to overseas regulators directly with attendant costs and time.
The ideal situation would be if India and her trading partner both have regulations and Indian regulations are at par with those of the trading partner, so that the products as regulated in India are accepted in the partner country with little or no extra effort. This means Indian regulations should be based on international standards, which is seldom the case.
| Understanding Regulations|| |
The technical regulations typically have two parts
The first part is the product requirements to be complied with by the industry: what we loosely call “standards.” The best option is that international standards are adopted in our regulations. In addition to product requirements, these regulations may also have requirements such as good manufacturing practices for drugs or good hygienic practices/hazard analysis and critical control point (HACCP) for food, and so on, especially when Ayurvedic products are also sought to be exported as food supplements.,
Secondly, the manner of demonstrating compliance to “standards”: by testing or inspection or certification, or a combination of any of them, what is called “conformity assessment,” which should also be based on international best practices/standards to be accepted overseas. This requires an adequate infrastructure of competent laboratories and inspection/certification machinery in the country available with the regulator. The competence is typically established through the international accreditation system, primarily where regulators rely on third-party agencies, which is increasingly becoming the norm globally.
| Challenges|| |
India and its industries face two challenges
First, we do not have regulations in place in many sectors, so the question of MRAs does not arise as the trading partners have free access to our market. At the same time, we face impediments in accessing their markets. Examples are chemicals, machinery safety, many medical devices, and so on, which are unregulated in India. In the case of Ayurveda, we do have regulations in place.
Secondly, even if we have regulations, these are not based on international standards, e.g., food products or pharmaceuticals; HACCP or WHO GMP is not prescribed in the case of food products and Ayurvedic medicines. Therefore, even regulated products are not likely to be accepted abroad.
| Harmonization of Regulations Is Not Necessary|| |
The good news is that even if we do not have regulations or our regulations are short of global standards, MRAs or one-way recognition of India’s certification is still possible. We need to demonstrate that India can manufacture to its trading partner’s “standards” or regulations and to demonstrate compliance in internationally acceptable ways.
Good examples to cite regarding the aforementioned situations
Organic certification program of Agricultural and Processed Food Products Export Development Authority (APEDA), which earned the recognition of various trading partners even though there were no regulations for organic products at that time (now Food Safety and Standards Authority of India has regulations in place which primarily rely on the APEDA system).
Seafood certification for exports by the Export Inspection Council, recognized by the European Commission (EC) since 1997, while India’s domestic regulations did not match EC’s or other countries’ regulations.
Therefore, acceptance of India’s certification/testing/inspection can be negotiated with the trading partners on the aforementioned principles, regardless of whether we have adopted international standards for the industry in domestic regulations or not.
| What Do We Need to Do?|| |
To seek recognition of Ayurvedic medicines abroad, we need to ask the following questions:
- a) Are our regulations at par with the global regulations, so that Ayurvedic products can be accepted globally—the answer is no.
- b) Do we have a system that could make them acceptable? We have a WHO GMP and Certificate of Pharmaceutical Products (CoPP) system. Still, these are accepted in some countries but not in developed markets such as the EU, USA, UK, Canada, and so forth.
- c) Do we need to have an alternate institutional system that could be presented globally—the answer is yes.
- d) Do we have such a system in place—the answer is yes, in the form of the Ayush Premium Mark Scheme, which has provision for certifying to overseas regulations.
At the behest of the then Department of Ayush, Government of India, the Quality Council of India (QCI) developed and launched the Ayush Premium Mark Certification Scheme in 2009, which was intended to fulfill precisely this need. It can serve as the institutional mechanism to certify importing countries’ regulations in which WHO GMP certificates and/or CoPP are unacceptable.
| Way Forward for Ayurvedic Medicines|| |
In the case of Ayurvedic medicines, although we may insist that Ayurvedic pharmacopeia of India is the book of standards, the GMP as per Schedule T is far short of the WHO GMP and is not acceptable currently in the global market.
Further, it is also essential to remember that metallic formulations are not permitted in most countries. Therefore, the focus should be on Ayurveda products having herbal ingredients that have a safe history of use.
Another issue of concern globally is contamination and non-compliance to quality parameters, which lead to inferior quality products that are not acceptable to other countries. Even developing countries are asking for CoPP, based on WHO GMP guidelines.
But WHO GMP certificate or CoPP as issued today is not acceptable in many developed countries, which calls for an alternate institutional system for certifying Ayurvedic medicines/products for exports.
For ease of understanding and to move ahead in exports of Ayurvedic medicines, the following steps are necessary:
Identification of 10 most commonly used Ayurveda medicines (traditional formulations) that can get licensed in other countries; e.g., Canada is open to such products under the Natural Health Products Directorate, and also there is no burden of licensing fees;
Development of the SOPs for their manufacturing;
Control of raw material (RM) sourcing with GACCP guidelines and traceability. To turn these whole herb botanicals into safe and clean ingredients, it is essential that proper procedures are to be followed routinely, and this can start well before the herbs are even harvested. This way, we can get consistent quality herbs. This step of good quality and safe RM is crucial to getting the batch-to-batch consistent finished product of good quality, free from contaminants. The National Medicinal Plants Board had launched a medicinal plant certification scheme based on WHO GAP and GCP in collaboration with QCI, the adoption of which can significantly help in this regard;
Upgradation of manufacturing units to international standards;
Validation of the manufacturing process;
Testing of the RMs and finished products at a laboratory that follows international standards (accredited as per ISO 17025, preferably by the National Accreditation Board for Testing and Calibration Laboratories, NABL).
| Conclusion|| |
The COVID-19 pandemic has, if it was needed, provided a massive window for the promotion of Ayurveda as a system of medicine globally. It is time we make a cohesive strategy to seek acceptance of Ayurvedic medicines by upgrading our manufacturing facilities in line with what is globally accepted and demonstrating an institutional system to certify Ayurvedic medicines/products to current global regulations.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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