 bill no xxxviii of 2006 the traditional herbal medicines (regulation of sale and compulsory evidence based trial) bill, 2006 a billto regulate the sale of the traditional herbal medicines which are being marketed withoutany licence and control under the cover of being manufactured by formulation provided in the ancient texts and to provide for compulsory listing and verification of ingredients of traditional herbal medicines and for matters connected therewith and incidental theretobe it enacted by parliament in the fifty-seventh year of the republic of india as follows:—1 (1) this act may be called the traditional herbal medicine (regulation of sale and compulsory evidence based trial) act, 2006short title, extent and commencement(2) it extends to the whole of india(3) it shall come into force with immediate effect5definitions2 in this act, unless the context otherwise requires,—(a) "authority" means the traditional herbal medicine quality control andverification authority established under section 6;10(b) "evidence-based trial" means testing of a traditional herbal medicine for itsresults of curing any disease wherein its toxicity and adverse effects have also gone through;(c) "over the counter (otc)" means availability of a traditional herbal medicine in any shop without any prescription by the authorised person;(d) "prescribed" means prescribed by rules made under this act;5act  no of 1940(e) "traditional herbal medicine" means any formulation being used either inhomoeopathy or ayurvedic system of medicine which has been mentioned in any of the ancient texts notified by the central government under the drugs and cosmetics act, 1940103 on and from the appointed day, as the central government may by notificationin the official gazette appoint in this behalf, no traditional herbal medicine shall be sold or made available over the counter4 every retailer or seller of traditional herbal medicines shall have to obtain alicence to sell traditional herbal medicines from the authority in such manner as may be prescribed5 (1) every manufacturer of traditional herbal medicine shall list the ingredientsof each medicine on the packing of the medicine along with their accurate quantity15(2) every manufacturer of traditional herbal medicine shall clearly and boldlyindicate on the packaging of the medicine any side effects and warning of contraindications in such manner as may be prescribedban on sale of traditional herbal medicines over the counter licence to selltraditionalherbal medicine for retailer manufacture to list the inpedient on packing of each traditional herbal medicine206 (1) the central government shall, by notification in the official gazette, establish an authority to be known as traditional herbal medicine quality control and verification authority for carrying out functions assigned under this actestablishment of traditional herbal medicine quality control and verification authority(2) the authority shall have its headquarters at lucknow in the state of uttar pradesh25(3) the authority shall have a chairman who shall be the retired judge ofhigh court and five other members to be appointed by the central government(4) the terms and conditions of the chairman and the members of the authority shall be such, as may be prescribed(5) the central government shall provide such number of officers and staff as may be required for efficient functioning of the authority30(6) the procedure for appointment of the members, their powers and functions and the procedure of filling up of vacancies shall be such, as may be prescribed(7) the authority shall have subordinate offices in the capitals of each ofthe states and union territories of the country35   (8)  the authority shall open as many laboratories for the purpose as may be required for meeting the objectives of this act:provided that the number of laboratories shall not be more than three inone state or union territory, as the case may be7 the functions of the authority shall be,—40functions of authority(i) to ensure quality control of the traditional herbal medicines; (ii) to arrange to verify the ingredient of any medicine; (iii) to act on the complaint received in respect of any medicine;act no 2 of 197445(iv)  to recommend cancellation of licence for selling of any traditional herbalmedicine;(v) to make the people aware about its findings of various spurious medicines;(vi) to conduct survey and inspection and random sample checking of everymanufacturer at least once in a year through its laboratories(vii) any other function that may be assigned58 the central government shall by due appropriation made by parliament bylaw in this behalf from time to time, provide adequate funds for the purpose of this actcentral government to provide funds penalty9 whoever violates the provisions of this act shall be liable for imprisonment for aterm which may extend to three years and shall also be liable to fine which may extend to ten lakh rupees10offence by acompany10 (1) where a person committing a contravention of any of the provisions of this actor of any rule, direction or order made thereunder is a company, every person who, at the time the contravention was committed, was in charge of, and was responsible to, the company for the conduct of business of the company as well as the company, shall be gulity of the contravention and shall be liable to be proceeded against and punished accordingly:15provided that nothing contained in this sub-section shall render any such person liableto punishment if he proves that the contravention took place without his knowledge or that he exercised all due diligence to prevent such contravention20(2) notwithstanding anything contained in sub-section (1) , where a contravention ofany of the provisions of this act or of any rule, direction or order made thereunder has been committed by a company and it is proved that the contravention has taken place with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of  the company, such director, manager, secretay or other officer shall also be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly25explanation:— for the purpose of this section:—(i) "company" means anybody corporate and includes a firm or other associationof individuals; and(ii) "director", in relation to a firm, means a partner in the firmact no 2 of 1974offences to be congnizable11 notwithstanding anything contained in the code of criminal procedure, 1973 theoffences under this act shall be cognizable and non-bailable30power to remove difficulties12 if any difficulty arises in giving effect to the provisions of this act, the centralgovernment may, by order published in the official gazette, make such provisions, not inconsistent with the provisions of this act, as appear to it to be necessary or expedient for removing the difficulty:35provided that no such orders shall be made after the expiry of the period of three yearsfrom the date of commencement of this actoverriding effect of the act13 the provisions of this act shall have effect notwithstanding anything inconsistenttherewith contained in any other law for the time being in force on the subject and save aforesaid the provisions of the act shall be in addition to and not derogation of any other law for the time in force40power to make rules14 the central government may by notification in the official gazette make rulesfor carrying out the purposes of this actoverriding effect of the act statement of objects and reasonsthe market in the urban and semi-urban area in the country is full of traditional herbal preparations now a days these medicines claim to cure various ailments from general fatigue to diabetes to cancer according to a report, a causal and random checking and testing of these medicines by the department of pharmacology of one of the premium referral hospitals in delhi revealed that many of them were contaminated containing steroids which in the long run could lead to suppression of immune system, growth retardation in children, diabetes and cataracts under the pretext of ancient texts and without any legal requirement of any licence to sell these medicines, these unchecked traditional medicines are causing serious ailments to their innocent users the absence of quality control and mechanism to verify the ingredients and the efficacy of many of these medicines have lead to the proliferation of the practice of dispensing these medicinesthere is no doubt about the prescription and formulations available in the ancient text, but at the same time, these medicines must go through the test for their toxicity and evaluation studies to say that herbal drugs do not have any side effects does not hold good as adverse effects are dependent on the time for which a particular drug is taken and the prescribed dosage this argument does not take into account the basic principle that any drug having a good effect will have an adverse effect too therefore, all herbal drugs are not safe in all circumstances some medicines are known to contain heavy metal including mercury and gold and some homoeopathic and ayurvedic medicines contain arsenic these have to be given in minute dosages under constant supervision, which does not happen the side effects of any medicine have to be listed on the cover but manufactures are not even listing the ingredients of the medicine medicine containing steroids and metals including mercury and arsenic are available over the counter with no warning or contra-indications market is flooded with herbal weight loss medicines, which have been found to be very harmful to kidneys and at times develop urinary track cancerthe rationale for not demanding evidence, based trial or efficacy test for traditional herbal drugs because they have been used for centuries and so they do not need fresh test, does not hold good as there are many fly by night operators who have taken advantage of this system although there are traditional herbal medicines from reputed companies, but many a time these are concoctions prepared by quakcs who after duping their patients run away with moneyinternationally, move towards regulation of traditional herbal medicine has already been initiated when certain medicines were found to be damaging human organs in some countriestherefore, it is high time that a regulatory mechanism for sale and evidence based trial may be adopted for traditional herbal medicines so as to obviate the unscrupulous elements which are taking advantage of the systemhence this billkalraj mishra financial memorandumclause 6 of the bill provides for establishment of an authority to be known as traditional herbal medicine quality control and verification authority for carrying out functions assigned under this bill clause 8 provides that the central government shall by due appropriation made in this behalf from time to time, provide adequate funds for the purposes of this act the bill, therefore, if enacted, will involve expenditure from the consolidated fund of india it is likely to involve a recurring expenditure of about rupees fifty crore per annuma non-recurring expenditure of about rupees five crore is also likely to be involved memorandum regarding delegated legislationclause 14 of the bill empowers the government to make rules for carrying out the purposes of the bill and the rules relate to matters of detail only the delegation of legislative power is, therefore, of a normal character———— a billto regulate the sale of the traditional herbal medicines which are being marketed without any licence and control under the cover of being manufactured by formulation provided in the ancient texts and to provide for compulsory listing and verification of ingredients of traditional herbal medicines and for matters connected therewith and incidental thereto————(shri kalraj mishra, mp)mgipmrnd—506rs(s5)—12052006