Anand Chaudhary , Neetu Singh
Department of Rasa Shastra
Faculty of Ayurveda, IMS
Banaras Hindu University, Varanasi -221005
Abstract
Obligation of rules and regulations are must for sophisticated functioning of any arrangement. Ayurvedic practices are in pressing need of appropriate and reasonable laws addressing all issues related to patients, physicians and producers of medicines. Existing provisions of laws dealing with Ayurvedic medicine are enough adequate to ensure availability of quality, safe and effective Ayurvedic medicine. But, by en large, these laws are unfamiliar to common masses as well concerned officials of government. Apart from these, efforts must be made to have new regulations which can facilitate practice of Ayurvedic drugs as per contemporary need with futuristic approach.
Key words
Drugs and Cosmetic Act & Rules, Adulterated, Standard, Pharmacovigilance
Introduction
With heights of acceptable parameters, Ayurveda is being recognised as system of medicine, globally. Especially, since last decade of previous century, there is tremendous upsurge in demand of Ayurvedic holistic doctrine for the elimination of diseases of ailing humanity and maintenance of health of common healthy man. [01] This elevation of system requires some regulations which may balance the strengths, weaknesses, opportunities and threats of Ayurvedic system of medicine. Commerce is basic cause for of all kind of cooperation, corruption and compromises in commencement of any assignment. Therefore, now it is felt that there is need of proper justified laws of land for smooth functioning of Ayurveda in terms of its pharmaceutics and therapeutics.
Insertion of Ayurveda in Drugs and Cosmetics Act, 1940
In provisions of Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945, subject matters of Ayurveda, Siddha and Unani (ASU) were instituted in Act 13 of 1964. A chapter IV –A was supplemented by this act consisting of section 33 B to section 33 O (table 01). [02] The inclusion of laws addressing issues related to Ayurveda in Drugs & Cosmetics Act provided new dimensions in legal recognition of system of Ayurveda. But, awareness, essential for proper practice of Ayurveda as system of medicine and to propagate and promote business of Ayurvedic medicaments may not be called as satisfactory, nationally as well as globally.
Salient Summits
The most significant involvement of these laws related to Ayurveda is its subjective substantiations in context of regulatory approaches to matters of Ayurveda. It accomplishes definition of Ayurvedic classical and proprietary drugs, need of board for technical advices – Ayurvedic [Siddha] Unani Drug Technical Advisory Board (ASUDTAB), and explanation of prohibited variety of Ayurvedic drugs viz misbranded, adulterated and spurious. Other subject matter dealt with prominence in act is power of prohibition of manufacture and sale of drug, provision of government analysts and inspectors, penalty of offences and subsequent offences and some more points of concern. [03] Modest portrayal of few assorted particulars of Act are discussed as under
Ayurvedic Siddha Unani Drug Technical Advisory Board (ASUDTAB)
Constituency of this board is reflecting a real representation of functionaries which should be involved for technical advices on different issues raised and taken for discussion regarding ASU drugs to help government for a genuine and authentic judicious decision on addressed problem. At present board consists members from government officials ( Ministry of Health ,dept of AYUSH ,GoI), director and analyst of drug laboratory , Pharmacognocist , Phyto-chemist ,members of respective pharmacopeia committee, academicians of several disciplines of knowledge of drug identification and manufacturing , regulators, physicians and industry representative of ASU sector.
The central government shall appoint a member of the board as its chairman. Secretary of the board may be appointed by Government of India. Office term for members of board is three year but they are eligible for renomination
Gratuitous Renounceable Drugs
Misbranded Drugs (section 33- E) –
That group of unwarranted Ayurvedic drugs which are coloured, coated or powdered to conceal the damage or made to appear better or greater therapeutic value, not labelled as per law of land and if accessories including container of the drug is depicting some item which may lead to false claim are categorised as misbranded drug . On proven charges one shall be punishable with imprisonment for a term which may extend to two years and with fine which shall not be less than fifty thousand rupees or three times the value of the drugs confiscated, whichever is more. [04]
Adulterated Drugs (section 33-EE) –
If filthy ,putrid or decomposed substances are part of product , drug is prepared ,packed or stored under insanitary conditions which may lead to contaminations causing injury to health of consumer ,medicine is mixed with a substance to reduce its quality or strength , container is composed of poisonous or deleterious substances are considered as Adulterated drugs . Guilty personnel and organisation will meet same treatment legally as per the provisions of misbranded drugs. [04]
Spurious Drugs (section 33-EEA) –
Group of drugs which are sold, offered or exhibited for sale, under a name which belongs to another drugs, a drug is imitated like another drug to deceive, if the label or containers bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist and if drug purports to be the product of a manufacturer of whom it is not truly a product are termed as spurious drugs. Penalty for this offence is imprisonment for a term which shall not be less than two years but which may be extend to six years and with fine which shall not be less than one lakh rupees or three times the value of the drugs confiscated ,whichever is more. [04]
Proscription Proclamations
For fair functioning of system of manufacturing, sale and distribution of ASU drugs, regulatory provisions are laid down to prohibit manufacture of any drug pertaining to ASU system for which government judges that it is being prepared in contravention of any of the provisions of drugs and cosmetics act, 1940 and rules 1945 with all its amendments of till date in interest of public health. [05]
Exemptions Edict
Rules of prohibition of section 33 –EEC and some other are not applicable to Vaidyas and Hakims who manufacture Ayurvedic, Siddha or Unani drugs for the use of their own patients. And nothing of this section shall apply to the manufacturing of ASU drugs for the purpose of examination, test or analysis prepared by personnel assigned for this particular purpose. [05]
Execution Expansion
A success of any act or rule solely depends upon methodology developed for its execution in letter and spirit. Drugs and Cosmetics Rules, 1945 is an extended execution of Drugs and Cosmetics Act 1940. Ayurvedic ,Siddha and Unani drugs are addressed in regulations viz rule 151 to 170 described in part XVI to part XIX of Drugs & Cosmetics Rule 1945 (table 02). Many mandatory forms are mentioned in schedule A, magnifying systematic method of licensing, quality control tests and GMP certification for manufacturing of Ayurvedic medicines. Schedules B-I, E (I), FF, T are dealing with several factors compulsory for standard, quality, efficacy and safety proved Ayurvedic medicine. [06]
Up to date Amendments
Amendments are symbol of contemporary movements to complement the contemporary causes. Thirteen amendments are notified in Gazette of India from 23/10/2008 to 19/08/2010.These amendments are ascertaining course of action for evaluation of different categories of Ayurvedic medicines as per guidelines quoted in rule 170. ASUDTAB has recommended shelf life /expiry date for ASU drugs under rule 161(B) which has facilitated export of Ayurvedic drugs as well as established belief of common Indian in these medicines. To encourage understanding and acceptability of Ayurvedic medicines further deptt of AYUSH amended Rule 158(B) regarding guidelines for issue of license for categories like neutraceutical, food supplement and cosmetics etc. [07]
Sensitivity of safety issue of herbo -mineral formulations of Ayurveda got attention of Indian Parliament and as per advice of the subordinate legislation of Parliament, corrigendum under Rule 157 (E) dated 4 th March, 2009 has been issued on GMP guidelines for manufacturing of “Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo – mineral – metallic compounds)” used in Ayurveda, Siddha and Unani medicines in addition of part II of schedule T ( GMP for Ayurvedic medicines of herbal origin ) of drugs and cosmetics rules 1945 notified in June 2000. Measures to be adopted for identification of raw material under rule 160 , 160 –A to 160 B and standardization of Ayurvedic medicine under rule 168 may produce proved Ayurvedic herbo -mineral preparation on account of its safety and efficacy as being propagated for medicines of mineral origin used in Chinese medicines. [07]
Auxiliary Aspects
The phenomenon of Pharmacovigilance is performed worldwide in conventional system of medicine (modern alias allopathy) since more than half centuries to ensure safety and efficacy of different dosage forms of modern medicine and reports of this programme are responsible for formation of new regulations to assure health of commoners. Certainly, there is pioneer
contribution of this programme which ascertained withdrawal of many molecules after reports of their adverse drug reactions through pharmacovigilance and post marketing surveillance due to rules made thereafter Deptt of AYUSH had activated Pharmacovigilance programme for ASU drugs since September 2008. Provisional conclusive reports are in pipeline which may definitely provide some basics for novel regulations regarding Ayurvedic medicines as per contemporary need.[08,09,10]
Concept of Reverse Pharmacology for traditional medicines is also very contributory in nature which might lead for conception of spanking new regulation on the basis of data and other evidences generated with adoption of doctrines of reverse pharmacology for Ayurvedic medicines. This may go ahead for a definitive cause for global acceptance of Ayurvedic medicines.[11,12]
Global Dogmatic Bills
The commercial component of companies and indefinable individuals involved in business of Ayurvedic medicines lead to several kinds of compromises and corruption causing continuous conditions of critical care for system of Ayurveda from all corners of continents, concomitantly. Point of concern, here is that due to these unwarranted reasons, several governments are in process of promulgation of authoritarian International laws regarding manufacturing and dispensing of traditional medicines (Ayurveda and other system of medicines ) which are enough tough to ensure health of their respective citizens. As common men is more susceptible to threat of any malpractices.
European Union (EU) guidelines namely Traditional Herbal Medicinal Products Directive (THMPD) which will be implemented from first May 2011in EU countries and other directives of Health Australia, Canada and US FDA are ensuring proper route of availability of these Ayurvedic medicines legally to their population. Researches in different laboratories of NICCAM- NIH, Germany, Japan etc. are working on traditional system of medicine of different countries including Ayurveda. One can hope that in due course of time laws of respective countries will acquire an innovative shape in light of these researches which may be in either side.[13]
Discussion
Ayurveda, one of the most appreciable systems of medicine is making its high perception among common masses across globe on virtue of its fundamental doctrines to treat human with medicine as well as modification in life style, not only account of materialistic criteria but with eliminations of mental critics too.
This unique circumstance is welcome state of affairs for every stakeholder of Ayurveda. Since last two decades numerous commendable assignments have been accomplished. New volumes of Ayurvedic Pharmacopeia of India (API ) ,Publication of protocol for analytical testing of Ayurvedic formulations by Pharmacopeial laboratory of Indian medicine (PLIM) ,Data base documents of Central Council for Research in Ayurveda and Siddha (CCRAS),volumes of Indian Council of Medical Research (ICMR) regarding Quality Standard of Medicinal plants and accommodation of extracts of Ayurvedic medicinal plants with nomenclature of Botanical Reference System (BRS ) in main stream would be a rationale for framing of some fresh laws for final legal accuracy of ASU medicines.
But, anxious conditions are also prevailing in our national scenario due to non compliance of accessible ruling of law of land regarding ASU medicines. Sub standard or legal penal action inviting drugs are also doing business in the market. One prominent and palpable argument for this situation is unawareness of Ayurvedic physicians, officials and public in general about any law about Ayurveda. The second explanation for this is lack of motivation among enforcement agency responsible for implementation of laws.\
However to deal with this flood of undesired range of medicines, deptt of AYUSH is introducing several procedures of certification of Ayurvedic medicines before marketing. Premium and standard brand of Ayurvedic medicines credited by Quality Council of India and recently initiated Bureau Veritas Certification for Ayurvedic medicines are proficient modus operandi to guarantee safe and effective Ayurvedic medicines to consumers. These two certifications are voluntarily to manufacturers as an additional assurance to customer with GMP and other analytical tests from government agencies. [14]
Therefore, one sincere and straight movement for wide spreading of laws dealing with Ayurvedic medicines is an urgent need of time which may change the situation of Ayurveda from an advisory approach to an authoritative system of medicine in light of law, worldwide.
References
es
- Satkopan Savita, Pharmaceutical standards and their role in quality control of ASU drugs, Proceedings of National workshop on Internationally acceptable standards for Ayurvedic Formulations ,2000,July 20-21,pp 12.
- Malik Vijay ,Laws Relating to Drugs & Cosmetics ,21 st edition Lucknow ,Eastern Book Company,2010,pp 46-55.
- Lohar D R ,Legal Status of Ayurvedic Siddha & Unani Medicines , 01 st New Delhi ,Deptt of AYUSH, Ministry of Health & Family Welfare ,2006,pp 20.
- Malik Vijay ,Laws Relating to Drugs & Cosmetics ,21 st edition Lucknow ,Eastern Book Company,2010,pp 48-49,52.
- Malik Vijay ,Laws Relating to Drugs & Cosmetics ,21 st edition Lucknow ,Eastern Book Company,2010,pp 49-50.
- Malik Vijay ,Laws Relating to Drugs & Cosmetics ,21 st edition Lucknow ,Eastern Book Company,2010,pp 87,207-223.
- Home page of website of department of AYUSH ,Ministry of Health & Family Welfare ,Government of India, updated 14/03/2011 available from http://www.indianmedicine.nic.in/showfile.asp?lid=337
- Chaudhary Anand ,Singh Neetu, Kumar Neeraj ,Pharmacovigilance: boon for the safety and efficacy of Ayurvedic formulations ,Journal of Ayurveda and Integrative Medicine 2010,:01;04:251-6
- Baghel M S ,The National Pharmacovigilance Programme for Ayurveda Siddha and Unani Drugs : Current status, International Journal of Ayurveda Research ,2010:1:4:197-8
- Thatte Urmilla ,Bhalerao Supriya, Pharmacovigilance of Ayurvedic medicines in India ,Indian J pharmacol,2008:40:suppl:810-812.
11-Vaidya Ashok D B ,Devasagayan Thomas PA,Current status of herbal drugs in India : an overview,J.Clin.Biochem.Nutr.,2007:41:01-11.
12 –Patwardhan Bhushan,Mashelkar R A,Traditional medicine – inspired approaches to drug discovery :can Ayurveda show the way forward ? Drug Discovery Today,2009:14:804-11
13– Home page of licensing herbal medicine products under the EU traditional herbal medicinal products directives, updated 14/03/2011 available from http.www.thmpd.eu
14-Info –Ayurveda, Association of Manufactures of Ayurvedic medicines, 2010:01; 07:09-11 available on www.amam-ayurveda.org .
Table 01 – Description of Contents of Drugs and Cosmetics Acts 1940 related to ASU drugs [02]
| Sr No | Section | Title |
| 01 | Section 03 | Definition of ASU drugs |
| 02 | Section 33 C | Ayurvedic Siddha and Unani Drugs Technical Advisory Board |
| 03 | Section 33 D | The Ayurvedic Siddha and Unani Drugs Consultative Committee |
| 04 | Section 33 E | Misbranded Drugs |
| 05 | Section 33 EE | Adulterated Drugs |
| 06 | Section 33 EEA | Spurious Drugs |
| 07 | Section 33 EEB | Regulation of manufacture for sale of ASU drugs |
| 08 | Section 33 EEC | Prohibition of manufacture and sale of certain ASU drugs |
| 09 | Section 33EED | Power of Central Government to prohibit manufacture, etc ,of ASU drugs in public interest |
| 10 | Section 33 F | Government Analysts |
| 11 | Section 33 G | Inspectors |
| 12 | Section 33 H | Application of provisions of section 22,23,24,and 25 |
| 13 | Section 33 I | Penalty for manufacture ,sale etc of ASU drugs in contraventions of this chapter |
| 14 | Section 33 J | Penalty for subsequent offences |
| 15 | Section 33 K | Confiscation |
| 16 | Section 33 KA | Disclosure of name of manufacture etc |
| 17 | Section 33 KB | Maintenance of records and furnishing of information |
| 18 | Section 33 L | Application of provision to governments depts |
| 19 | Section 33 M | Cognizance of offences |
| 20 | Section 33 N | Power of Central Government to make rules |
| 21 | Section 33 O | Power to amend first schedule |
Table 02 – Description of Contents of Drugs and Cosmetics Rule 1945 related to ASU drugs [06]
| Sr No | Rule | Title |
| 01 | 151 | Manufacture on more than one set of premises |
| 02 | 152 | Licensing authorities |
| 03 | 153 | Application of licence/loan licence to manufacture |
| 04 | 154 | Form of Licence/loan licence |
| 05 | 155 | Certificate of Renewal/GMP |
| 06 | 156 | Duration of licence/loan licence |
| 07 | 157 | Condition for the grant of renewal of licence |
| 08 | 158 | Condition of licence /loan licence |
| 09 | 159 | Cancellation and suspension of licence |
| 10 | 160 | Identification of raw material/application for grant of approval for testing of ASU drugs etc. |
| 11 | 161 | Labelling ,packing and limit of alcohol etc |
| 12 | 162 | Duties of inspectors /qualification of state drug licencing authority etc |
| 13 | 163 | Procedure for dispatch of sample to government analyst and its receipt by the government analyst etc |
| 14 | 164 | Method of test or analysis to be employed in relation to ASU drugs |
| 15 | 165 | Qualification of Government Analyst |
| 16 | 166 | Duties of government analyst |
| 17 | 167 | Qualification of inspector |
| 18 | 168 | Standards to be complied in manufacture for sale or for distribution of ASU drugs |
| 19 | 169 | Permitted excipients |
| 20 | 170 | Evaluation of Ayurvedic medicines |
