Emerging quality control perspectives for ayurvedic drug
Journal name: Ayushdhara
Original article title: Emerging quality control perspectives for ayurvedic drug
AYUSHDHARA is an international peer-reviewed journal. It focuses on research in Ayurveda, Yoga, Unani, Siddha, Homeopathy, Allopathy, and Pharmaceutical Sciences.
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*Kurele Rajeev
Manager QC, QA and F&D, Person-in-charge, AYUSH DTL (Govt. Approved Lab.), Indian Medicines Pharmaceutical Corporation Limited, (A Govt. Of India Enterprise under ministry of AYUSH), Mohan, Almora, Uttrakhand
B Srinivasulu
Reader, Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre, Shobhit University, Gangoh, Saharanpur, Uttar Pradesh
Katoch Dinesh
Advisor (Ayurveda), Ministry of AYUSH, Govt. of India, New Delhi
Dhiman KS
DG, CCRAS, Ministry of AYUSH, Govt. of India, New Delhi
Joshi V.K.
Ex.-Dean, IMS, Banaras Hindu University, Varanasi. Chairman of Ayurvedic Pharmacopoeia Committee
Prajapati PK
Head of Department, Rasa Shastra & Bhaishjaya Kalpna, All India Institute of Ayurveda, New Delhi
Ayushdhara:
(A peer-reviewed, bi-monthly open-access journal)
Full text available for: Emerging quality control perspectives for ayurvedic drug
Year: 2016
Copyright (license): CC BY-NC-SA 4.0
Download the PDF file of the original publication
Summary of article contents:
Introduction
The AYUSH system of medicine, which encompasses Ayurveda, Unani, and Siddha practices, is a burgeoning sector in India's healthcare landscape. The industry includes a wide array of products such as herbal medicines, nutraceuticals, cosmeceuticals, and veterinary medicines. With over 771,000 registered AYUSH practitioners and nearly 9,000 licensed Ayurvedic drug manufacturing units, there is significant potential for growth both domestically and internationally. The Ministry of AYUSH is committed to enhancing educational standards, quality control, and the standardization of drugs to ensure the effectiveness and safety of Ayurvedic treatments. Amidst these opportunities, the industry faces challenges regarding drug quality that necessitate focused attention from policymakers and regulators.
Quality Control and Assurance in AYUSH Pharmaceuticals
Quality Control (QC) and Quality Assurance (QA) play critical roles in the manufacturing of Ayurvedic medicines. QC is concerned with fulfilling specific quality requirements and involves defect detection, primarily through testing processes. In contrast, QA focuses on defect prevention through process management. The Ministry of AYUSH emphasizes improving up-to-date knowledge of QC/QA guidelines and implementing Good Manufacturing Practices (GMP) to ensure that Ayurvedic products meet both national and international standards. The QC/QA processes involve multiple stages, including thorough sampling of raw materials, monitoring during the production process, and testing of finished products to meet established quality criteria.
Importance of Regulation and Standardization
The establishment of regulatory frameworks and standards is essential for the AYUSH industry to thrive. The Ministry of AYUSH has undertaken substantial steps to enhance drug quality by implementing stringent regulations, such as mandatory GMP compliance and licensing for manufacturers. These regulations aim to safeguard public health by prohibiting the manufacture and sale of substandard or spurious drugs. The government's proactive measures also include the formation of advisory boards and consultation committees focused on herbal drugs. Additionally, continuous training and awareness programs are vital for educating industry stakeholders on quality practices and compliance.
Conclusion
In conclusion, the AYUSH system of medicine possesses vast potential for growth, but this can only be realized through diligent efforts in quality control and regulatory compliance. As international interest in traditional Indian medicine grows, the emphasis on quality assurance becomes increasingly vital. A collaborative approach involving government initiatives, industry participation, and academic contributions will be necessary to cultivate a robust framework for the safe and effective use of Ayurvedic drugs. The active engagement of all stakeholders—ranging from policymakers to practitioners—is crucial to advance the quality and reputation of AYUSH products on a global scale.
FAQ section (important questions/answers):
What are the key challenges in Ayurvedic drug quality assurance?
The Ayurvedic drug industry faces challenges such as lack of awareness of QC/QA procedures, poor infrastructure, insufficient skilled personnel, and issues with raw material authenticity and availability. Furthermore, there is a need for better scientific documentation and standardization.
What role does the Ministry of AYUSH play in drug quality?
The Ministry of AYUSH oversees quality control and standardization for Ayurvedic drugs, including regulatory enforcement. It establishes guidelines for Good Manufacturing Practices (GMP) and compiles pharmacopoeial standards to ensure drug safety and efficacy.
Why is quality control essential in Ayurvedic medicine production?
Quality control ensures the safety, efficacy, and consistency of Ayurvedic medicines. It helps identify the purity and potency of drugs, ensuring that they meet regulatory standards and fulfill consumer expectations for health treatments.
Glossary definitions and references:
Scientific and Ayurvedic Glossary list for “Emerging quality control perspectives for ayurvedic drug”. This list explains important keywords that occur in this article and links it to the glossary for a better understanding of that concept in the context of Ayurveda and other topics.
1) Drug:
In the context of Ayush, a drug refers to any substance used in the diagnosis, treatment, or prevention of diseases in Ayurvedic, Unani, Siddha, and Homeopathy (ASU & H) systems. Quality control and standardization are crucial for ensuring the efficacy and safety of these medicines.
2) Ayus (Ayush):
Ayush stands for Ayurveda, Yoga, Unani, Siddha, and Homeopathy. It represents the traditional systems of medicine practiced in India, focusing on a holistic approach to health, encompassing prevention and treatment of diseases using natural remedies.
3) India:
India is the birthplace of the Ayush systems of medicine, which include Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The country has a rich heritage of medicinal plants and a large number of Ayush practitioners, making it a significant player in the global herbal medicine market.
4) Medicine:
In the Ayush context, medicine refers to formulations made from plants, minerals, and other natural substances. These medicines are used to treat various ailments, promote health, and prevent diseases, following principles outlined in ancient texts such as the Ayurvedic Pharmacopoeia.
5) Ayurveda (Ayus-veda):
Ayurveda is an ancient system of medicine originating in India. It emphasizes a holistic approach to health, considering the balance of body, mind, and spirit. Ayurvedic treatments use herbs, minerals, and diet to restore and maintain health.
6) Siddha:
Siddha is one of the traditional systems of medicine in India, primarily practiced in Tamil Nadu. It uses a combination of herbs, minerals, and metals for treating various ailments, following texts written by ancient saints known as Siddhars.
7) Indian:
The term Indian refers to anything related to India, including its traditional systems of medicine like Ayurveda, Unani, Siddha, and Homeopathy. India is known for its rich cultural heritage and significant contributions to natural and holistic healthcare.
8) Disease:
In the context of Ayush, a disease is considered an imbalance in the body's doshas (Vata, Pitta, and Kapha). Treatment focuses on restoring balance through natural remedies, lifestyle changes, and dietary adjustments.
9) Knowledge:
In Ayurveda, knowledge is essential for understanding the principles of life, health, and disease. Ayurvedic texts provide detailed information on the properties of herbs, minerals, and treatment methods, contributing to the holistic approach to healthcare.
10) New Delhi:
New Delhi is the capital of India and houses the Ministry of AYUSH, which oversees the development, regulation, and promotion of traditional systems of medicine in the country. It plays a crucial role in policy-making and quality control standards.
11) Pesticide:
The presence of pesticide residues in herbal medicines is a concern. Quality control measures ensure that Ayurvedic drugs are safe and free from harmful levels of pesticides, in adherence to regulatory standards.
12) Vaidya:
A Vaidya is a traditional Ayurvedic physician skilled in diagnosing and treating diseases using Ayurvedic principles. Historically, Vaidyas prepared medicines themselves, ensuring high standards of quality and efficacy.
13) Purity:
Purity in the context of Ayurvedic medicine refers to the absence of contaminants and adherence to specified quality standards. Ensuring the purity of raw materials and finished products is crucial for the safety and effectiveness of Ayurvedic treatments.
14) Powder:
In Ayurvedic medicine, powders are a common form of dosage. They are made through processes like grinding or combination of various herbs and minerals, ensuring the appropriate consistency and quality for therapeutic use.
15) Delhi:
[see source text or glossary: Delhi]
16) House:
[see source text or glossary: House]
17) Sama (Shama):
[see source text or glossary: Sama]
18) Veterinary medicine:
Ayurvedic principles are also applied in veterinary medicine to treat animals. Herbal formulations are used to promote health and treat various diseases in animals, ensuring their well-being naturally.
19) Science (Scientific):
Quality control and standardization of Ayurvedic medicines increasingly incorporate scientific methods and modern instrumentation to ensure the efficacy and safety of traditional formulations.
20) Dravya:
Dravya refers to the substances or raw materials used in Ayurvedic medicine, including herbs, minerals, and animal products. Quality control ensures that these materials meet the required standards for therapeutic use.
21) Bhishaj (Bhishak, Bhisak, Bhisaj):
[see source text or glossary: Bhisak]
22) Aureus:
[see source text or glossary: Aureus]
23) Animal:
Animals play a role in Ayurvedic medicine both as sources of certain ingredients and as recipients of treatment. Quality control ensures the safety and efficacy of these treatments, whether for humans or animals.
24) Pitta:
Pitta is one of the three doshas in Ayurveda, responsible for metabolism and transformation in the body. Balance of Pitta is essential for maintaining health, and its imbalance can lead to diseases.
25) Kapha:
Kapha is one of the three doshas in Ayurveda, associated with structure and lubrication in the body. It is important to maintain a balance of Kapha to ensure overall health and prevent diseases.
26) Rasa (Rasha):
Rasa in Ayurveda refers to taste, which is fundamental in determining the medicinal properties of substances. The concept of Rasa is used to classify and understand the therapeutic potential of herbs and foods.
27) Yoga:
Yoga is an integral part of the Ayush systems, promoting physical, mental, and spiritual health through practices like postures, breathing exercises, and meditation.
28) Rogin (Rogi):
Rogi refers to a patient in Ayurvedic terms. The treatment focuses on the individual’s unique constitution and the balance of doshas to restore health.
29) Food:
In Ayurveda, food is considered medicine and plays a crucial role in maintaining health and treating diseases. Dietary guidelines are tailored to individual constitutions and specific health conditions.
30) Rasashastra (Rasa-shastra, Rasasastra):
Rasa-shastra is the Ayurvedic practice of using minerals and metals in medicinal formulations. Quality control ensures that these ingredients are processed safely to enhance their therapeutic benefits and minimize toxicity.
31) Pharmacology:
In Ayurveda, pharmacology involves the study of the properties and effects of herbs, minerals, and other natural substances used in treatments. Traditional knowledge is validated through modern scientific methods for quality and efficacy.
32) Samagni (Sama-agni):
[see source text or glossary: Sama-agni]
33) Substance:
[see source text or glossary: Substance]
34) Evolution:
[see source text or glossary: Evolution]
35) Education:
Education is crucial for the development and standardization of Ayurvedic medicine. The Ministry of AYUSH emphasizes upgrading educational standards to ensure practitioners are well-versed in traditional and modern healthcare principles.
36) Varanasi (Varanashi):
Varanasi is home to the Institute of Medical Sciences at Banaras Hindu University, a prominent center for Ayurvedic education and research, contributing to the standardization and quality control of Ayurvedic practices.
37) Swelling:
[see source text or glossary: Swelling]
38) Indriya (Imdriya):
[see source text or glossary: Indriya]
39) Shastra (Sastra):
[see source text or glossary: Shastra]
40) Mineral:
Minerals are used in Ayurvedic medicine, especially in Rasa-shastra. They undergo rigorous quality control to ensure they are processed correctly for safe and effective use in treatments.
41) Bhasma (Bhasman):
Bhasma refers to ash derived from minerals and metals, used in Ayurvedic formulations. Quality control ensures that Bhasma meets safety and efficacy standards through proper processing and testing.
42) Dharma:
[see source text or glossary: Dharma]
43) Shukra (Sukra):
Shukra refers to one of the seven vital tissues in Ayurveda, related to reproductive health. The balance of Shukra is essential for overall vitality and well-being.
44) Arogya:
Arogya means health or well-being in Ayurvedic terms. The aim of Ayurvedic treatment is to achieve a balanced state of Arogya by maintaining harmony of body, mind, and spirit.
45) Liquor:
[see source text or glossary: Liquor]
46) Moksha (Moksa):
[see source text or glossary: Moksha]
47) Kriya:
[see source text or glossary: Kriya]
48) Satva (Shatva):
[see source text or glossary: Satva]
49) Artha:
[see source text or glossary: Artha]
50) Asthi (Ashthi):
Asthi refers to bones, considered one of the seven vital tissues in Ayurveda. Maintaining the health of Asthi is essential for structural integrity and overall health.
51) Rakta:
Rakta refers to blood, one of the seven vital tissues in Ayurveda. It is crucial for nourishing the body and maintaining vitality, and its imbalance can lead to various health issues.
52) Nidra:
Nidra means sleep, one of the three pillars of health in Ayurveda. Proper sleep is essential for maintaining balance and overall health, influencing both physical and mental well-being.
53) Asava (Ashava):
Asava refers to a type of Ayurvedic fermented preparation that enhances the therapeutic properties of herbs. Quality control ensures the proper fermentation process and efficacy of Asava formulations.
54) Majja:
Majja refers to bone marrow, one of the seven vital tissues in Ayurveda. It is essential for producing blood cells and maintaining the body's vitality and strength.
55) Joshi (Josi):
[see source text or glossary: Joshi]
56) Glass:
[see source text or glossary: Glass]
57) Sweating (Sweat):
Sweat is one of the waste products in Ayurveda. Proper elimination of sweat is essential for maintaining health and preventing the accumulation of toxins in the body.
58) Veda:
Veda refers to the body of knowledge in ancient Indian texts. Ayurveda, being a part of the Vedas, is the science of life and health, providing detailed insights into maintaining health and treating diseases.
59) Agni:
Agni refers to the digestive fire in Ayurveda, essential for digestion and metabolism. Balanced Agni ensures proper digestion, absorption of nutrients, and elimination of toxins, contributing to overall health.
60) Medas (Meda, Medash):
Meda refers to fat tissue, one of the seven vital tissues in Ayurveda. It provides insulation, energy storage, and supports various bodily functions. Proper balance of Meda is essential for health.
61) Dosha (Dosa):
Dosha refers to the three fundamental energies (Vata, Pitta, Kapha) that govern physiological and psychological functions in the body. Balance of doshas is essential for health, and their imbalance leads to disease.
62) Kama:
[see source text or glossary: Kama]
63) Atman (Atma):
[see source text or glossary: Atma]
64) Vata:
Vata is one of the three doshas in Ayurveda, associated with movement and communication in the body. Balance of Vata is crucial for nervous system function, circulation, and overall well-being.
65) Guna:
[see source text or glossary: Guna]
66) Aha (Ahan, Ahar):
Ahar means food or diet in Ayurveda. The right Ahar is essential for maintaining the balance of doshas, overall health, and prevention of diseases, tailored to individual constitutions and health conditions.
67) Tree:
[see source text or glossary: Tree]
68) Diet:
Diet is integral to Ayurvedic treatment. It plays a crucial role in maintaining health and treating diseases by balancing the doshas through foods that suit an individual’s constitution and current health condition.
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