You are on page 1of 6

Regulations Globally, there have been concerted efforts to monitor quality and regulate the growing business of herbal

drugs and traditional medicine. Health authorities and governments of various nations have taken an active interest in providing standardized botanical medications. Government of India has also plunged into this opportunity and initiated some regulations in this sector. To ensure and enhance the quality of !" medicines, the Government of

India has notified Good #anufacturing $ractices %G#$& under !chedule 'T( of the )rugs and *osmetics ct +,-. which also ensures raw materials used in

the manufacture of drugs are authentic, of prescribed quality and are free from contamination. The guidelines for Good gricultural $ractices %G $&

seek to lay down a cultivation programme designed to ensure optimal yield in terms of both quality and quantity of any crop intended for health purposes. It puts forth a standard for production of raw material that goes in to the making of the !" medicines and standardizes the production s a matter of fact it can be seen that there

processes from farm to factory.

is a direct correlation between efficacy of an herbal drug with the quality of raw material used and the process of manufacturing. It is of paramount importance that no compromise is made on quality. /uality of raw material being watched over by following G $ and G *$, for manufacturing and marketing the prepared drugs, government has formulated the )rugs and cosmetics act, +,-.. It is an act to regulate the import, manufacture,

distribution and sale of drugs and cosmetics. This act was basically initiated for chemical drugs but later in the year +,0, a separate chapter relating to yurveda, !iddha and "nani drugs was inserted by act +1 of +,0-. 2aws are partly same as those for conventional pharmaceuticals. 2ater on this was again modified with some substitutions in the year +,31, +,34, +,,- and

5..5. The schedules and rules pertaining to systems in the act are6
Schedules:

yurveda, !iddha and "nani

7irst !chedule substituted by act +1 of +,0- came into force w.e.f +858+,0,. The schedule lists the standard Indian pharmacopoeias to be followed for manufacturing yurveda, !iddha and "nani drugs. bout 94 books of yurveda %with insertions in +,34, +,,-, 5..5&, 5, of !iddha %+,34&, +1 of "nani Tibb system are listed.

!econd !chedule came into force w.e.f +9..,80-. It states about the standard to be complied for manufacturing drugs. %!ubs. by :otifn. :o. G.!.;. 339, dated the -th ugust, +,41, Gazette of India, $t. II, s. 1%i&, p. +0-1.& !*H<)"2<8<%+& 6 2ist of poisonous substances under the yurvedic %including !iddha& and "nani !ystems of #edicine % dded by :otfn. :o. +851=048) dt. 5858+,4.& differentiated into vegetable, animal and mineral origin. !*H<)"2< T6 Good #anufacturing $ractices %G#$& for ayurvedic, siddha and unani medicines. %Ins by G.!.;. 90+ %<& dt 518.085... and subs. by G.!.;. +,3%<&, dt. 4.1.5..1.&. "nder !chedule >T? of the drugs and cosmetics act +,-., the government has made it mandatory for all manufacturing units to adhere to G#$.

Rules: ;ules6 $art @AI %$arts @AI, @AII and @AII added by !.B. 0-5, dt. the 5858+,4. %w.e.f. 5+.5.+,4.& #anufacture for sale of ayurvedic %including siddha& or unani drugs. It notifies about how to acquire license, loan for establishing a unit and also on the identification of raw materials and its purity.

$art @AI 6 pproval of institutions for carrying out tests on ayurvedic, siddha and unani drugs and raw materials used in their manufacture on behalf of licensees for manufacture for sale of ayurvedic, siddha and unani drugs %Ins. by G.!.;. 4.+%<&, dt. 548485..+ and subs. by G.!.;.41 %<&, dt. 1+8.+85..1.& $art @AII6 2abelling, packing and limit of alcohol in ayurvedic %including siddha& or unani drugs. %!ubs. by G.!.;. ,.-%<&, dt. 5.++.+,,5.& $ ;T @AIII6 Government analysts and inspectors for ayurvedic %including siddha& or unani drugs. $ ;T @I@6 !tandards of ayurvedic, siddha and unani drugs %Ins. by G.!.;. 9+,%<&, dt. 50.0.+,,9.&

XI Five year plan The @I five year plan also gives emphasis on developing herbal sector. round 0... species of medicinal plants are documented in published medical and ethno8botanical literature. Cild populations of several hundreds of these species are under threat in their natural habitats. In the Tenth $lan, a :ational #edicinal $lants Doard %:#$D& was established for supporting conservation of gene pools and large scale cultivation of medicinal%five year plan&. However, there have been no official efforts so far to conserve these resources. The key challenges in the <leventh 7ive Eear $lan are to conserve gene pools of red listed species, support large8scale cultivation of species that are in high trade, involve forestry sector in plantation of medicinal tree species, and establish modern processing zones for post8harvest

management of medicinal plants. The key interventions and strategies in the <leventh 7ive Eear $lan are6

<nsuring conservation of medicinal plants gene pools as well as promoting cultivation of species in high trade and establishment of medicinal plants processing zones. !trengthening regulatory mechanism for ensuring quality control, ;F), and processing technology involving accredited laboratories in the government and non8government sector.

IPR issues There have been several eGamples wherein the knowledge embodied in traditional practices relating cultural to medicinal plants, traditional cultural of

eGpressions=folklores,

artefacts

and

genetic

resources

communities in India has been misappropriated or attempts have been made to do so. The application of eGisting I$; laws and eGisting frameworks have given rise to several issues, which has required a strong movement to protect the biopiracy by institutung machanisms both at the national and the international level. t the moment India does not have any specific

legislation for protecting TH. The modalities of it are still emerging and evolving. The 2egal protection accorded to traditional knowledge in India is through6

India(s patent laws with the

mendment

ct of 5..9 which contains

provisions for mandatory disclosure of source and geographical origin of the biological material used in the invention while applying for patents and also allowed the composition of a drug to be patented.

The Indian Diodiversity act 5..5 which follows the *onvention for Diological )iversity(s guidelines regarding benefit sharing.

India

has established a

central authority >:ational

Diodiversity

uthority?to monitor and control foreign access to Indian biological resources including traditional medicine.

)evelopment of a database called >Traditional Hnowledge )igital 2ibrary ?%TH)2& that will document as well as establish the prior art to hinder patenting Indian knowledge. This task has been entrusted to :I!* I;, a *!I; laboratory.

t the international level, the Inter8governmental *ommittee on Intellectual $roperty and Genetic ;esources, Traditional Hnowledge and 7olklore under Corld Intellectual $roperty Brganization %CI$B&, is considering various concerns and issues of misappropriation of TH and looking for means and principles for protection of TH. ways F

Absence of regulatory regime In olden times, vaidyas used to treat patients on individual basis, and prepare drug according to the requirement of the patient. Dut the scene has changed nowI herbal medicines are being manufactured on a large scale in mechanical units, where manufacturers come across many problems such as

availability of good quality raw material, authentication of raw material, availability of standards, proper standardization methodology of single drugs and formulations, quality control parameters, etc. *urrently the regulatory regime formulated does not encompass all these issues as the country is still in the developing stage of a strict formulatory. To become well poised and a maJor player it has to work upon the gaps therein by revamping F redefining the laws.

Loss to the country The rich heritage of traditional systems of medicine and vast repository of natural resources puts India at a promonent position in global scenario of herbal sector. Dut to revitalize these traditions, the route employed is being considered as erratic. #edicines produced in large scales are generally being compromised on their quality resulting in poduction of substandard or spurious drugs. nd with the absence of regulation there is no way to keep a

rein on it. This has proJected indigenous medicines in a bad repute. The concept of vaidyas prescribing and formulating medicines according to the need of an individual has been replaced by "niversity educated doctors prescribing BT* medicines. The holistic and individualistic approach, one of the keystones of the systems remains now critics aver, antiquated. The traditional lineage of vaidyas is being lost. !o present day need is to revive the systems along the lines of prevalent traditions and promote the usage of herbal medicnes otherwise our heritage will be lost, resulting in a great loss to the country. The World Health Organization (WHO), the specialized agency of the United Nations (UN) that is concerned with international public health, published Quality control methods for medicinal plant materials in 1998 in order to support WHO Member States in establishing quality standards and specifications for herbal materials, within the overall context of quality assurance and control of herbal medicines.[49]

In the European Union (EU), herbal medicines are now regulated under the European Directive on Traditional Herbal Medicinal Products. In the United States, most herbal remedies are loosely regulated dietary supplements by the Food and Drug Administration.[citation needed] Manufacturers of products falling into this category are not required to prove the safety or efficacy of their product, though the FDA may withdraw a product from sale should it prove harmful.[50][51] The National Nutritional Foods Association, the industry's largest trade association, has run a program since 2002, examining the products and factory conditions of member companies, giving them the right to display the GMP (Good Manufacturing Practices) seal of approval on their products.[citation needed] Some herbs, such as cannabis and coca, are outright banned in most countries though coca is legal in most of the South American countries where it is grown. The cannabis plant is used as a herbal medicine, and as such is legal in some parts of the world. Since 2004, the sales of ephedra as a dietary supplement is prohibited in the United States by the Food and Drug Administration.,[52] and subject to Schedule III restrictions in the United Kingdom.