THE GOBAL AND DOMESTIC MARKET SIZE OF CRUDE DRUG
INTRODUCTION-
CRUDE DRUG-
The global plant-derived products market is expected to gain momentum over the
projected period due to the low cost of herbal medicines compared to allopathy.
These drugs are witnessing significant consideration at a global level. For instance, in
China, this form was used to treat severe acute respiratory syndrome (SARS).
Increasing preference for cost-effective treatment options for various medical
conditions such as cold & cough, kidney disorders, digestive problems and chest
congestion is anticipated to enhance the further acceptance of these medicine forms
worldwide.
The herbal plants with several medicinal properties are used to treat a variety of
disease conditions. Furthermore, a single plant may contain many chemical
constituents such as phenols, glycosides, polysaccharides, alkaloids, resins, and
terpenoids which demonstrate therapeutic activities in more than one medical
conditions.
For instance, various polyphenolic compounds such as tannins, curcumin,
flavonoids, and gallacatechins are considered to possess anti-cancer properties and
are expected to gain popularity owing to increasing prevalence of cancer.
Furthermore, high treatment cost of cancer coupled with pipeline programs revealing
anti-cancer activities of plants is anticipated to increase the use of these in various
therapies.
Herbal medicines are formulated in dosage forms such as tablets & capsules, powders,
extracts, pastes, gels, and oils. Tablets & capsules provide dose accuracy compared to
other dosage forms. Hence, the segment is expected to record the fastest growth over the
forecast period. Poor regulatory framework across the globe and less number of
institutes providing knowledge of herbal therapeutics due to lack of relevant research
evidence are expected to hinder the market growth.
Herbal drug formulations-
Herbal formulations means a dosage form consisting of one or more herbs or
processed herbs in specified quantities to provide specific nutritional, cosmetic
benefits meant for use to diagnose, treat, mitigate diseases of human beings or
animals, alter the structure or plant physiology of human beings or animal.
Safe and Effective Veterinary Medicinal Products
Veterinary medicines, also known as medicinal products for veterinary use,
veterinary drugs or veterinary medicinal products (VMPs), have to be authorised
before being placed on the internal market. The Union Register of medicinal
products provides information on centrally authorised medicinal products and
procedures. To receive a marketing authorisation , all veterinary medicinal
products must undergo a scientific evaluation of their quality, safety and
efficacy.
The current requirements and procedures for granting a marketing authorisation
for veterinary medicinal products are laid down primarily in Directive
2001/82/EC and in Regulation (EC) No 726/2004.
Divergent transposition of the provisions of Directive 2001/82/EC in the Member
States has led to different levels of public and animal health protection and
created obstacles to the functioning of the internal market. To improve the
situation of the veterinary sector, the European Commission proposed a
harmonised and proportionate regulatory framework on veterinary medicinal
products. It aims to create a legal environment, which is modern, innovative and
fit for purpose.
The new Regulation (EU) 2019/6 on veterinary medicinal products, published on
7 January 2019, repeals Directive 2001/82/EC and brings the following main
achievements:
harmonises the internal market for veterinary medicinal products
reduces the administrative burden
enhances the internal market
stimulates innovation
provides for incentives to increase the availability of veterinary medicinal
products
strengthens the EU action to fight antimicrobial resistance.
As part of its implementation, the Regulation requires the European Commission
to adopt delegated and implementing acts.
Current legislation on Veterinary medicinal products
To facilitate the interpretation of the legislation and its uniform application
across the EU, numerous guidelines of a regulatory and scientific nature have
been adopted. These documents are compiled in the various volumes of “The
Rules Governing Medicinal Products in the European Union”, also known as
EudraLex.
The current legislation governing veterinary medicinal products is contained
in EudraLex – Volume 5.
The marketing authorisation procedures are detailed in EudraLex – Volume
6 – Notice to applicants
Scientific guidance on the quality, safety and efficacy of medicinal products
is given in EudraLex – Volume 7.
The FDA regulates a wide range of products, including foods (except for aspects of some
meat, poultry and egg products, which are regulated by the U.S. Department of
Agriculture); human and veterinary drugs; vaccines and other biological products;
medical devices intended for human use; radiation-emitting electronic products;
cosmetics; dietary supplements, and tobacco products.
Pharmacutical excipients-
There are several explanations to pharmaceutical excipients covering origin,
regulatory and functionality aspects.
“The word excipient is derived from the Latin excipere, meaning ‘to except’, which is
simply explained as ‘other than‘. Pharmaceutical excipients are basically everything
other than the active pharmaceutical ingredient. Ideally, excipients should be inert,
however, recent reports of adverse reactions have suggested otherwise.” (Australian
Prescriber)
“Pharmaceutical excipients are substances other than the active pharmaceutical
ingredient (API) that have been appropriately evaluated for safety and are
intentionally included in a drug delivery system.”
Simply said the excipients enable the drug substance to be applied to the patient in
the right form and supports the way and place of action without being active
themselves.
.Global and domestic market size of sweeteners-
An overview of the global market for sugars and sweeteners in processed foods
and beverages, with reviews of sugar, corn-derived sweeteners like high-
fructose corn syrup, sugar alcohols, and other less commercially important
caloric sweeteners, as well as aspartame, acesulfame-K (Ace-K), sucralose,
and the oldest product, saccharin.
Analyses of global market trends, with data from 2012, 2013 and 2014, and
projections of CAGRs through 2019.
Discussion of the sources from which sweeteners are derived, applicability and
functionality, caloric content, and benefits and drawbacks for each.
Examination of driving forces such as government regulations, technological
advances, research and development of new additives, and international
factors, and how these forces can promote or retard the development and
marketing of current and new sweeteners.
Comprehensive company profiles of major companies in the sweeteners
business, including sweetener manufacturers and processors, as well as food and
beverage processors.
.Demand and supply position crud drug-
India has very strong traditional health care practices that are represented by the classical
systems of medicine like Ayurveda, Siddha, Unani, and Swa-rigpa on one hand, and by a
very diverse area-specific and community-specific folk healthcare practices on the other. The
major commonality of the Indian classical and the folk health care traditions is their
dependence upon the raw material derived from a large diversity of plant species, which is
estimated to be about 6,500.
The first serious attempt at national level to assess the demand and supply of medicinal plants
in the country was made by the National Medicinal Plant Board during 2001-02, when it
commissioned a study through CERPA to understand annual trade levels of selected 162
medicinal plant species. The NMPB, thereafter in 2006-07 commissioned a national study to
assess demand and supply of medicinal plants in India. That study, carried out by FRLHT, for
the first time brought various intricacies in the herbal sector to the fore and added to the
understanding of the subject related to the diversity of raw drug entities in trade, their
botanical correlation, volume of annual trade and supply sources.
To assess the current Demand and Supply scenario of medicinal plants, NMPB has
extensively surveyed the herbal market of India in collaboration with ICFRE, Dehradun. The
estimate of consolidated commercial demand of herbal raw drugs for the year 2014-15 has
been has been estimated at 5,12,000 MT. Estimated Exports of Herbal Raw Drugs, including
Extracts has been estimated 1,34,500 MT in 2014-15. Estimated Consumption by Domestic
Herbal Industry has been estimated 1,95,000 MT 2014-15. An Estimated 1,67,500 MT of
Herbal Raw Drugs are also Used by Rural Households every year. About 1178 medicinal
plant species recorded in the practices of trade. Out of which, 242 plant species are used in
annual quantities of more than 100MT.
Export and import-
.Traditional medicinal product-
The demand for herbal/value added extracts of medicinal herbs is gradually increasing in
foreign countries, especially in European and other developed countries.
In order to promote India’s exports, the Government has taken several measures:
i. Department of Commerce has set up Export Promotion Councils for promoting
exports of various product groups / sectors. The mandate of export promotion of
Herbs and Medicinal Plants has been assigned to Shellac & Forest Products Export
Promotion Council (SHEFEXIL), headquartered at Kolkata. The export promotion of
several Herbal Products has been assigned to Pharmaceuticals Export Promotion
Council (PHARMEXCIL), besides others. These EPCs facilitate the exporting
community and undertake various export promotional measures for promotion of
export of their products.
ii. Under Market Access Initiative (MAI) Scheme of the Department of Commerce, the
EPCs / 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.
iii. 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.
iv. ‘Niryat Bandhu Scheme’ has been galvanised and repositioned to achieve the
objectives of ‘Skill India’ and trade promotion/awareness.
v. International Cooperation Scheme of Ayush Ministry provides financial assistance to
the exporters for the participation in Trade Fairs, organising International Business
Meets & Conferences and product registration reimbursements.
vi. The National Medicinal Plants Board (NMPB), Ministry of AYUSH, Government of
India has launched a “Voluntary Certification Scheme for Medicinal Plants Produce
(VCSMPP)” on 22nd November, 2017 in order to encourage the Good Agricultural
Practices (GAPs) and Good Field Collection Practices (GFCPs) in medicinal plants.
The VCSMPP will enhance the availability of the certified quality medicinal plants
raw material in the country and also boost their export and increase India’s share in
the global export of herbs.
vii. Ministry of Ayush through its Quality Certification programme like Ayush mark and
Premium mark is also assisting industry in setting up of quality standards.
viii. Ministry of Ayush has entered into MoUs with few countries for promotion of
traditional medicine which will help exports in long .
*Essential oils-
Essential oils are often used in aromatherapy, a form of alternative
medicine that employs plant extracts to support health and well-being.
However, some of the health claims associated with these oils are
controversial.
This article explains all you need to know about essential oils and their
health effects.
Spices-
A spice is a seed, fruit, root, bark, or other plant substance primarily used for
flavoring, coloring or preserving food. Spices are distinguished from herbs,
which are the leaves, flowers, or stems of plants used for flavoring or as a
garnish.
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