For a product to be certified as Ayurvedic, it has to be screened through quality verifications set by Quality Council of India (QCI), an autonomous body set up by the government and the Indian industry.
Ayurvedic drugs, on the other hand are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India (DCGI). To formulate a standardised and centralised system across India, DCGI is assisted by statutory bodies like Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) and Ayurveda, Siddha, Unani Drugs Consultative Committee (ASUDCC).
For medicinal drugs to have Ayurvedic certification, they need to be issued the Certificate of Pharmaceutical Products (CoPP) for Ayurveda product by DCGI. At present the CoPP as per WHO GMP certification are granted by Central Drug Standard Control Organisation (CDSCO).
The Certificate of Pharmaceutical Product (CoPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the statusof the pharmaceutical product and of the applicant for this certificate in the exporting country.
GMP (Good Manufacturing Practice) is the international regulations for securing the Quality of Medicines, including cultivation, harvesting, storage, production and processing of products.
Good manufacturing practice (GMP) is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients, diagnostics, foods, pharmaceutical products and medical devices
GMP Certification confirms the products identity, composition, quality, purity and strength which they represent in the market. Under it, there is a set of guidelines that offer a system of procedures and documentation by which the confirmation of the products are given.
The GMP certificate to manufacturers of Ayurveda, Siddha and Unani medicines are issued only after complying with the requirements of GMP of Ayurveda, Siddha and Unani drug with regard to the location and surroundings, buildings, water supplies, disposal of waste, container cleaning, stores for raw material, packing materials, finished goods, working space, sanitation and hygiene of workers, machinery and equipment’s, manufacturing record, distributions
record and facility with regard to quality controls, etc. as laid down in Schedule T of Drugs and Cosmetics Act, 1940.
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Through a voluntary certification scheme for AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) products instated in 2009, QCI renders Ayurveda products with ‘premium’ and ‘standard’ quality labels that comply with international or national guidelines respectively. These are also known as AYUSH Premium Mark and AYUSH Standards Mark.
Ayush Ministry has introduced voluntary quality certification systems in accordance with World Health Organisation (WHO) Good Manufacturing Practices (GMP) guidelines and Quality Council of India (QCI) scheme of Ayush Premium Mark due to emerging trade and export opportunities for Ayurvedic medicines.
Ministry of Ayush has also entered into MoUs with a few countries for promotion of traditional medicines which will help exports in the long run.
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To make exports more reliable and more efficient, the Ministry made the GMP as a mandatory quality certificate scheme compulsory for all AYUSH manufacturers. Thus with the current scenario, "GMP" is mandatory while" Ayush Premium Mark" is still Voluntary. (There are only 8 companies registered with the Ayush mark for their products as of now in India).
Manufacturers of Ayurveda Products and Drugs can get their Products tested and certified at any of the Labs designated and approved by Ayush Ministry.Complete list of labs is available at the Ayush site www.ayush.gov.in for reference.
Schemes initiated by the Govt of India for boosting Ayurveda EXIM.
Ayush Cluster Scheme for Manufacturers
The ‘Scheme for Development of AYUSH Clusters’ is a Central Sector Scheme. The Scheme would be implemented with Support from Department of AYUSH and support would be by the way of grant to the Special Purpose Vehicle (SPV), formed by group of entrepreneurs from AYUSH sector.
The Ayush Cluster defined for the purpose of this scheme would be an area covering a radius of 100 kms and at least 15 participating enterprises (Manufacturers of Ayurvedic Products) be located in this cluster.
The financial assistance would be restricted to 60 % of the Project Cost subject to a maximum of Rs. 15.00 crores.
The assistance under the scheme would be available to units operating in the following sectors; located in existing clusters i.e. a group of AYUSH enterprises located in close proximity:
- Ayurveda
- Siddha
- Unani
- Homeopathy
- Yoga and Naturopathy
Ayush Research and Development Aid for Prioritised Diseases
The main objective of this scheme of assistance is to aid the Development of Research and Development (R & D) based AYUSH Drugs for prioritized diseases and to develop AYUSH products having Intellectual Property Rights (IPR) potential for increasing AYUSH exports.
Organizations (both Government and Private) , Laboratories, Drug Manufacturers, etc. having adequate infrastructure in terms of equipment and manpower to conduct high quality research are eligible for this aid.
The main aim, scope and objective of this scheme are to aid in the research and development of Ayush Drugs.
Schemes for Export of Ayurvedic Products
The export promotion of several Herbal Products has been assigned to Pharmaceuticals Export Promotion Council (PHARMEXCIL) https://pharmexcil.com/
This council aids Herbal Manufacturers and Exporters in some of the ways listed below:
- Under Market Access Initiative (MAI) Scheme of the Department of Commerce, the EPCs and Trade Bodies are provided financial assistance for participation and organizing Trade Fairs, Buyer Seller Meets (BSMs), Reverse Buyer Seller Meets (RBSMs), Research & Product Development, Market Studies, etc.
- Merchandise Exports from India Scheme (MEIS) provides incentives to the exporting community for specified goods so as to offset infrastructural inefficiencies and the associated costs of exporting products produced in India, giving special emphasis to those which are of India’s export interest and have the capability to generate employment and enhance India’s competitiveness in the world market.
- International Cooperation Scheme of Ayush Ministry provides financial assistance to the exporters for the participation in Trade Fairs, organizing International Business Meets & Conferences and product registration reimbursements.
- The National Medicinal Plants Board (NMPB), Ministry of AYUSH, Government of India has launched a “Voluntary Certification Scheme for Medicinal Plants Produce (VCSMPP)” In order to encourage the Good Agricultural Practices (GAPs) and Good Field Collection Practices (GFCPs) of medicinal plants. The VCSMPP will enhance the availability of the certified quality medicinal plants raw material in the country and create export avenues for the farmers opting for the cultivation of herbs and medicinal plants across the country. https://www.nmpb.nic.in/
One of the most acclaimed schemes of this board is to help in claiming reimbursements of the expenses occurred for obtaining any Quality Certificates for exporting natural products. A reimbursement of up to 50 % of the expenses incurred can be claimed.
Links for reference and form downloads:
- https://www.thebetterindia.com/
- https://basicayurveda.co.in/
- https://isoindia.org/
- http://www.pharmabiz.com/
- https://www.qcin.org/
- https://ibt.tpci.in/
- https://main.ayush.gov.in/ testing laboratories
- https://main.ayush.gov.in/ development of ayush clusters
- https://main.ayush.gov.in/ scheme for extra mural research
- https://www.eepcindia.org/
- https://www.bankbazaar.com/
- https://main.ayush.gov.in/
- https://www.nmpb.nic.in/
- https://pharmexcil.com/
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