15. AYUSH Report_Chapter 10

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10 Ayurvedic Veterinary Products (AVP) – Status and Future Prospects


Ayurvedic Veterinary Products (AVP) – Status and Future Prospects General Overview of Veterinary Sector

269

Ayurveda and Animal Health

270

Current Regulatory Status

270

Conclusions and Recommendations

272

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10 Ayurvedic Veterinary Products (AVP) – Status and Future Prospects1 decades.

General Overview of Veterinary Sector Animal health care is of great importance as it forms a vital part of the food chain. Concerns about food safety has grown after the use of chemicals, hormones and anti-biotics in rearing animals and poultry became widely known. As residues of antibiotics/chemical drugs remain a part of the food chain, their use is being discouraged in Europe and several other countries.

The composition of the livestock population has also undergone significant transformation. Within cattle, there has been a marked shift from work animals towards milch animals. As a result, the number of crossbred cows has increased from three million to around 10 million.

India is currently the largest producer of milk in the world. It produces 110 million tones of milk annually. The per capita availability of milk increased from 112 gm per day to about 250 gm per day. However, the yield of Indian breeds is still far below the world average and nowhere near the yield of cows in developed countries.

Apart from being an important contributor to the national income, animal husbandry is one of the ways of reducing poverty and unemployment in rural areas. A large majority of livestock owning households comprise of small and marginal farmers and landless households – poorest sections of society. Overall, the distribution of livestock is much more equitable than that of land. The bottom 60 percent of rural households own 65 percent of all milch animals. Therefore, the health of

Since India is one of the biggest consumers of milk and milk products, there is a growing concern about the nutrition and medication given to milch animals. Veterinary products play a big role in animal and poultry rearing. India’s share livestock

of

world

population

of

The population of different livestock species as per the 18th livestock census 20072 places India at first rank for having the largest buffalo population, second in respect of cattle and goats, and third in respect of sheep. India has the fifth largest poultry population in the world.

The contribution of the livestock sector to agriculture is about 22 percent which contributed four to six percent of the National GDP during the last two

1. The preparation of this chapter was done in consultation of Dr. DB Anantanarayan, Advisor, M/s Natural Remedies Ltd. The figures quoted in the chapter were supplied by Dr. Amit Agarwal from M/s Natural Remedies Ltd. Group of Industries, and is based on market research carried out by them along with data available in public domain. 2. Department of Animal Husbandry Dairying and Fisheries, Government of India.

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livestock becomes very important being a source of sustenance and livelihood. Market size and segments of the total veterinary sector3 The total Animal Health market is valued at around Rs. 2500 crore and is growing annually by eight to 10 percent. •

Of this fifty-three percent (Rs. 1325 crore) caters to the health and well being of cattle.

Thirty-seven percent (Rs. 925 crore) caters to the poultry segment.

Five percent (Rs. 125 crore) worth of products are used for domestic pets.

Five percent (Rs. 125 crore) is for the well-being of “other animals” (Aqua / equine).

Veterinary health products can be categorized into therapeutics, food additives and bio security products. •

Therapeutics have a market size of Rs. 1025 crore (41percent)

Food additives have a market size of Rs 750 crore (30 percent)

Bio-security products have a market size of Rs.725 crore (29 percent)

Ayurveda and Animal Health In ancient India, the use of animals in agriculture, transportation, food and on the battle field was widespread. As such veterinary science was well developed. Ayurveda has many branches like Gauayurveda, Hastyayurveda, Ashvayurveda, Mrig-Ayurveda, Vriksha-ayurveda, etc. These Ayurvedic sciences were later enriched with literature and practices followed from the

17th century onwards. There is a need and an opportunity to revive veterinary Ayurveda. In the Schedule 1 of Drugs and Cosmetics Act, more than 50 official books are listed but none of them are specific to veterinary Ayurveda. Several veterinary specific dosage forms are yet to be included in the Ayurvedic Formulary of India. Ayurvedic veterinary drug industry The Ayurvedic veterinary drug industry in India has been contributing to the treatment of both common ailments as well as newly emerging diseases. There are more than 80 Ayurvedic veterinary drug producing companies functioning at present. The total size of the industry is estimated at Rs. 400 crore, growing annually by 22 to 25 percent. Thus, out of the total animal health market of Rs. 2500 crore, the Ayurvedic Veterinary Products (AVPs) constitute 16 percent of the total animal health market. This sub-sector primarily consists of the following categories: 1.

Digestives

2.

Liver support agents

3.

Lactation promoters

4.

Nutritives/Tonics

5.

Anti bloating agents

6.

Anti stress agents

7.

Anti diarrheal agents

8.

Uterine tonic/ecbolic agents

Current regulatory status In India, though exact data about non-human use of antibiotics is not available but it is well known that antibiotics are used widely to

3. The data was sought to be confirmed through official channels but no response was given despite reminders.

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prevent and treat animal infections. Nontherapeutic usage of antibiotics has been especially common in poultry production. The Prevention of Food Adulteration Rules, 1995-part XVIII: Antibiotic and other Pharmacologically Active Substances, regulates the use of antibiotics and other pharmacologically active substances. Enforcement is carried out by authorized Central and State Government organizations. The Departments for Animal Husbandry at the Centre and in the State Governments oversee all aspects relating to the regulation of veterinary education, practice and drug manufacture. However, currently either there are no effective regulations regarding the use of antibiotics in livestock or there is very weak compliance of the regulations as there is little importance given to this issue. As a part of the National Policy on Anti-microbial use, it was inter alia recommended that alternative medicine should also be practiced. The committee under the Chairmanship of Director-General of Health Services (DGHS) has formulated the National Policy on Antimicrobial use4, and it is understood that there is also a committee under the Council for Scientific and Industrial Research (CSIR).Inputs about the possibilities for the use of Ayurvedic or alternative medicine could not be found. Inputs from the AYUSH sector are needed because the Department of Animal Husbandry, Ministry of Agriculture, is not in a position to directly make any recommendations about Ayurvedic medicine. It is necessary that the AYUSH sector focuses on developing evidence-based substitutes for antibiotics, which are widely used for disease prevention and growth promotion in milch animals and poultry. This can help reduce extra-human use of antibiotics. It can also

contain anti-microbial resistance which is a big source of concern. In the Inter-sectoral Committee proposed under the National Policy on Anti-microbial use, there is need for identifying a nodal person to represent the interests of AYUSH, Health and Animal Husbandary so that guidelines for use of antibiotics in livestock and replacing them in a phased manner with alternative medicine including herbal drugs can be evolved. Licencing Products

Requirements

for

Veterinary

Veterinary Ayurvedic Products (VAPs) are regulated under the Drugs and Cosmetics Act, 1940 – 1945 and Rules thereunder. Two categories of pre-market licenses have to be obtained before introducing VAPs in the market. These are “Classical Ayurvedic Formulations” and “Patent & Proprietary Ayurvedic Products”. Classical Ayurvedic Formulations are prepared as per the formula & procedures given in ancient literature and Ayurvedic Patent & Proprietary medicines are new combinations of products made using herbs which are recognized and accepted in the official books. The Sub-Committee for Veterinary Ayurvedic Formulations of the Ayurvedic Pharmacopoeia Committee has identified 22 such books which should be included in the schedule to the Act. These products require to be licensed by the Licensing Authority or the Director of Ayurveda depending on the policy of each state. There is need to distinguish between VAPs which are primarily feed supplements and those which are medicines as the standards are different. The PI was told that there were inconsistencies and varying interpretations relating to excise,

4. Inputs from Dr. LS Chauhan, Director, National Centre for Disease Control (NCDC), New Delhi.

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sales tax and other levies and much greater clarity is needed. Currently, the VAP industry adopts the same quality parameters prescribed for raw herbs, extracts, minerals mentioned in The Ayurvedic Pharmacopoeia of India or The Ayurvedic Formulary of India. Conclusions and Recommendations Need to prepare an Ayurvedic Veterinary Pharmacopoeia There is a need to prepare and publish a separate Ayurvedic Veterinary Pharmacopoeia covering the VAPs. A separate Veterinary Pharmacopoeia has been published in the case of synthetic drugs and pharmaceuticals (Published by Indian Pharmacopoeia Commission). It is understood that the newly formed Pharmacopoeia Commission for Indian Medicines (PCIM) has formed a Veterinary Ayurvedic Committee to initiate this work. However, the availability of resources and of lab facilities need to be looked into so that the work is expedited. Separate section for ASU veterinary sector There is a need to initiate inter-ministerial dialogue/cooperation between the Department of AYUSH, Ministry of Health and Family Welfare and the Department of Animal Husbandry, Ministry of Agriculture. Within the Department of AYUSH, there should be at least a Director level officer who can understand the specific needs of the veterinary sector and facilitate the approval of regulations apart from suggesting modifications as necessitated by experience. The ASU veterinary sector should be given representation on the

ASUDTAB. There are several government notifications which have been issued keeping only the human application of ASU medicines in mind. There is a need to either exempt ASU veterinary medicines from the purview of such notifications or to look into their applicability for the veterinary sector. Training veterinary manpower on Practice of AVPs Veterinary health care is in the hands of veterinary doctors (VDs), veterinary livestock inspectors (VLIs), artificial insemination workers (AIWs) and village level workers (VLWs). All been estimated, there are around 25,000 qualified vets and 80,000 (VLIs, VLW’s and AIW’s) engaged in the veterinary sector5. The number of veterinary doctors being limited, they generally attend to serious and complicated cases only. A vast majority of the common metabolic disorders (which are generally self limiting and non-life threatening) are attended to by VLIs, VLW’s and AIW’s. Most of the licensed Ayurvedic drugs are meant for common metabolic disorders. There is a need to encourage the paramedical veterinary manpower to understand the benefits of traditional veterinary medicine. Companies engaged in the manufacture of Ayurvedic veterinary products should be encouraged to impart know-how and training to the para-medical workers. Prioritizing ASU veterinary sector Ayurvedic Veterinary medicines are sold based at a relatively lower cost compared to modern medicine. While the traditional

5. (a) Rajendra Singh, Pratap Singh Birthal, B S Rathore, 1998, “Review of animal health services in India”, The Indian Journal of Animal Sciences, 68(5). (b) Ghotge, Nitya, and Sagari. Ramdas, 2002. “Women and Livestock: Creating Space and Opportunities.” LEISA Magazine 18 (4) (December): 16–17.

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products are cheaper, the main ingredients being medicinal plants are becoming more and more expensive. As a result, Ayurvedic veterinary medicine is losing its major edge over Allopathic drugs, which was the cost consideration. There is a need to encourage research and simplify regulations so that manufacturers can use cheaper alternatives as substitutes. However, unless the regulations focus on the advantages of using non-synthetic alternatives, the opportunity will be lost. The Ayurvedic veterinary sector is yet small but it has a huge potential given the interest in natural products and the large global population of animals and poultry that can be treated for at least some conditions without resorting to the use of chemicals. Greater encouragement to R&D and awareness building through Animal Husbandry camps and schemes would also provide an impetus but bridges need to be built to create an interest and an understanding. Need to create balya-poshak/positive health promoter category outside the drug category There are a large number of animal feed supplements of both synthetic as well as herbal origin. These products are in line with the Ayurvedic philosophy that it is better to maintain health and prevent disease rather

than treat diseases at a later date. From a brief interaction with some stakeholders the PI got the impression that manufacturers as a group are reluctant to approach the authorities for including such products under the “balya-poshak/positive health promoter” category as this category has been created as a sub-section of patent and proprietary “medicines” used for human health promotion only. When the main cause of veterinary diseases is improper nutrition, traditional Ayurvedic enhancers and drugs can play a significant role in enhancing animal health provided suitable regulations are put in place to encourage Ayurveda Balya-Poshak products in the veterinary category. A meeting with Ayurvedic Veterinary drug producers is therefore called for to give a direction to this. There is also an apprehension that the Ayurvedic Drug Licensing Authorities may object to combining herbal ingredients with synthetic ingredients like vitamins and nutrients. The Food Safety and Standards Authority of India (FSSAI) has apparently not prepared any guidelines as yet for licensing veterinary products. There is a need to take a view on the responsibility for laying standards and for monitoring in this area.

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