India

Policy

The Government of India introduce a National Policy on Indian Systems of Medicine & Homoeopathy (ISM&H) in the year 2002 to improve the traditional systems of medicine. Ayurveda, Siddha, Unani & Homeopathy systems of medicine and drugless therapies like Yoga and Naturopathy are officially acknowledged in India. The major aims of this policy are:

  • To promote good health and expand the outreach of health care to people, particularly those not provided health cover, through preventive, promotive, mitigating and curative intervention through  AYUSH
  • To ensure affordable AYUSH services & drugs which are safe and efficacies;
  • To facilitate availability of raw drugs which are authentic and contain essential components as required under pharmacopoeia standards to help improve quality of drugs, for domestic consumption and export;
  • Integrate AYUSH in health care delivery system and national programmes and ensure optimal use of the vast infrastructure of hospitals, dispensaries and physicians;
  • To provide full opportunity for the growth and development of these systems and utilization of the potentiality, strength and revival of their glory.

Contact

Department of AYUSH: http://indianmedicine.nic.in/

For the matters related to Dietary Supplements:

Ministry of Health
Nirman Bhawan
New Delhi  

For the matters related to Traditional Medicines:

Ministry of Health & Family Welfare
IRCS BUILDINGS  
Red Cross Road
New Delhi – 110001  
Drugs Controller General of India 
Ministry of Health 
FDA Bhawan, 
Kotla Road-  ITO 
New Delhi 110011

 

 

Laws & Regulations

Recent regulations for dietary supplements have been established in India under the direction of the Ministry of Health with the Food Safety and Standards Act of 2006.  This Act allows dietary supplements to be regulated as foods and has created a new category which accommodates the various categories of dietary supplements such as Nutraceuticals, Functional Foods, Foods for Special Dietary Application and general nutritional supplements.  Any representation which suggests or implies that a food has particular qualities relating to its origin, nutritional properties, nature and processing, composition or otherwise  must be approved  prior to marketing as approved  standards have been established.  Since the regulations have just been recently introduced, their implementations are not fully completed and no formal post-marketing surveillance program is in place. There is also lack of clarity for some of the regulations.

Botanicals which are considered drugs are listed with and regulated by the Drug and Cosmetic Act 1940. GMP (Good Manufacturing Practices) procedures and all regulatory issues are the same as that of pharmaceutical drugs.  These products are sold in pharmacies as drugs and over-the-counter medications.

The regulation of Traditional Medicines is well established in India under the Department of Ayush. The Department of Ayush (Ayurvedic, Yoga & Naturopathy, Unani, Siddha and Homeopathy) was created in 2003 from an earlier organization. It is aimed at upgrading all educational systems, improving the development and quality control of herbal medicines, ensuring availability of raw materials, funding research and development and educating the consumer and international stakeholders of the value of Indian traditional practices.

In February 2013, Delhi Declaration on Traditional Medicine was adopted by regional Member States during the international conference on traditional medicine in New Delhi. The participating countries agreed to cooperate, collaborate and mutually support each other, thus 9 items including promotion of national policies and strategies for equitable development and appropriate use of traditional medicine, pursuing a harmonized approach to education, practice and research in traditional medicine as well as exchanging perspectives, experiences and experts for integrating traditional medicine into national health system. 

Contact

For the matters related to Dietary Supplements:

Ministry of Health
Nirman Bhawan
New Delhi  

For the matters related to Traditional Medicines:

Ministry of Health & Family Welfare
IRCS BUILDINGS  
Red Cross Road
New Delhi – 110001  
Drugs Controller General of India 
Ministry of Health 
FDA Bhawan, 
Kotla Road-  ITO 
New Delhi 110011

 

Standards & Guidelines

In 1993, guidelines for the safety and efficacy of herbal medicines enforced by the expert committee appointed by Indian Government aimed to merge into the Drugs and Cosmetics Act and rules. The guideline proposed that for a new herbal medicines introduced, other than authorized by the licensing authorities are not allowed to manufacture or market except for the medicinal herbs which mentioned in the "authoritative" books for Ayurveda, Siddha and Unani Medicines. Data which compulsory to give for the marketing authorization application for a new herbal medicines include safety and efficacy data. 

A classification for herbal medicines was divide into 3 categories which depends on market availability and the nature of the herbs [1].

  • Category 1: already in use for more than 5 years
  • Category 2: in use for less than 5 years
  • Category 3: new medicines

Good Manufacturing Practice (GMP) is technical support issued by WHO in 2007 to assure the safety and quality of herbal medicines during the manufacturing process. However, it is advisable for other countries to develop their own national GMP for manufacturing herbal medicines which suits to the country's actual situation [2]

In terms of guidelines for agricultural and collection of herbal medicine's plants, this country obey to the documents by WHO title "WHO Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants" [3]

There is another documentation known as "Good Agricultural and Collection Practices for Medicinal plants" which developed as a manual for farmers and Collectors in handling medicinal plants. The illustrated booklet is produced from a collaboration of FAO, in collaboration with the Directorate of Medicinal and Aromatic Plant Research, Gujarat of Indian Council of Agricultural Research as part of an IFAD funded project “Organic Production of underutilized Medicinal, Aromatic and Natural Dye Plants Program for Sustainable Livelihoods in South Asia (GCP/RAS/208/IFA)” [4]

The book title “Prevention of Aflatoxin Contamination In Herbal Medicinal Plants" which sold in the country highlighted the guidelines on application of Good Storage Practice (GSP), Good Trade and Distribution practices (GTDP) for medicinal plants to avoid contamination to herbal medicines by Aflatoxin [5]

In 2009, "Guidelines on Good Field Collection Practices for Indian Medicinal Plants" is produced in collaboration of National medicinal Plants Board Department of AYUSH and WHO Country Office for India. The content in the documentation includes guidelines for harvesting, post harvesting and packaging of the medicinal plants [6]

Contact

Ministry of Health and Family Welfare
Website: http://mohfw.nic.in/

References

  1. Suparna Mukherji. The healing herbs of India. Available from: http://www.teriin.org/tg_april_2011.pdf
  2. WHO. Guidelines on good manufacturing practices (GMP) for herbal medicines. Available from:http://apps.who.int/medicinedocs/documents/s14215e/s14215e.pdf
  3. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for Medicinal Plants. Available from:http://whqlibdoc.who.int/publications/2003/9241546271.pdf
  4. Food and Agricultural organization of the United Nations. Trainer’s manual on Good Agricultural and Collection Practices (GACP) for Medicinal plants. Available from: http://www.dmapr.org.in/research/illustratedbooklet.pdf
  5. Chandra PS, Rajesh G, Anurekha J. Prevention of Aflatoxin contamination in herbal medicinal plants. Lambert Academic Publishing, 2006. Available from: https://www.lap-publishing.com/catalog/details//store/gb/book/978-3-659-20718-1/prevention-of-aflatoxin-contamination-in-herbal-medicinal-plants
  6. National medicinal plants board department of AYUSH. Guidelines on good field collection practices for Indian medicinal plants. Available from: http://nmpb.nic.in/WriteReadData/links/7687590193Good Field Collection Practicies (GFCPs) Booklet - Part - I.pdf
  7. WHO. WHO Traditional Medicine Strategy 2014-2023. Available at http://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/