as introduced in the rajya sabhaon 16th march, 2007 bill  no  xv  of  2007 the herbal medicines (regulation of production, distribution, sale and advertisement) bill, 2007 a billto provide for regulation of production, distribution, sale and advertisement of herbal medicines in the country and for matters connected therewith or incidental theretobe it enacted by parliament in the fifty-eighth year of the republic of india as follows:—1 (1) this act may be called the herbal medicines (regulation of production,distribution, sale and advertisement) act, 2007short title, extent and commencement(2) it extends to the whole of india (3) it shall come into force at oncedefinitions2 in this act, unless the context otherwise requires,—(a) "advertisement" means any visible representation by way of notice, circular, label, wrapper or other document and also includes any announcement orally or otherwise;(b) "distribution" includes distribution or supply of herbal medicines by way of sample;(c) "herbal medicine" means any formulation of a medicine being used in ayurvedic and homoeopathy system of medicine which has been mentioned in any of the ancient text notified by the central government under the drugs and cosmetics act, 1940(d) "label" means any written marked stamped, printed or graphic matter fixed to or appearing upon any package;(e) "licence" means licences to be obtained to produce, supply, distribute and sell herbal medicines from the drugs controller of india(f) "package" includes wrapper, box, carton, tin or other container; (g) "prescribed" means prescribed by rules made under this act; (h) "production" means manufacturing or producing medicines and includes packing, labeling of containers of herbal medicines;(i) "sale" means sale of herbal medicine in any shop without any licence3 (1) every person engaged in the production and distribution of herbal medicines shall obtain a licence to produce and distribute the herbal medicines(2) no person shall sell, or permit sale of herbal medicines to any other person without licencemandatory licence to produce and distribute herbal medicines prohibition of advertisement of herbal medicines4 no person engaged in the production, distribution and sale of herbal medicines shall advertise such medicines and no person having control over a medium shall cause to be advertised herbal medicine through that medium unless accompanied by a licence under this act5 (1) no person shall produce, distribute or sell herbal medicines unless every package of herbal medicine bears thereon or on its label the list of ingredients of each content along with its accurate quantity(2) any side effects of the herbal medicine and warning of contraindication shall be displayed on its label in such manner as may be prescribed6 (1) the specified ingredients and warning on a package of herbal medicines shall be:—packet of herbal medicines to have a list of ingredients and warning of contraindications warning on package to be legible and clear(a) legible and prominent; (b) conspicuous by size and colour(2) the size of letters and figures on the label shall be such as may be prescribed by the rulespower to search and seizure7 (1) any police officer, not below the rank of a deputy superintendent of police or any officer of drug administration authorized by the central government may if he has any reason to suspect that any provision of this act has been or is being contravened, enter and search in the manner prescribed, at any reasonable time, any factory building and business premises(2) the provisions of code of criminal procedure 1973, shall apply to every search and seizure made under this act(3) if the police officer and the person authorized by the central government referred in sub-section (1) has reason to believe that any provision of this act has been contravened in respect of any package of herbal medicine, he may seize such package in such manner as may be prescribedconfiscation of package8 (1) any package of herbal medicines in respect of which any provision of this act has been contravened shall be liable to be confiscated by an order of the court of jurisdiction(2) no order adjudging confiscation shall be made unless the owner or the person in possession of the package of herbal medicine has been given a notice in writing informing him of the grounds, on which it is proposed to be confiscated and giving him a reasonable opportunity of being heard and make representation in such manner as may be prescribedpenalty9 whoever contravenes the provisions of this act shall on conviction, be punishable—(a) in the case of first conviction with imprisonment for a term which may extend to three years or with fine which may extend to twenty thousand rupees or with both(b) in the case of second or subsequent conviction with imprisonment for a term, which may extend to five years or with fine which may extend to one lakh rupees10 notwithstanding anything contained in the code of criminal procedure, 1973, an offence punishable under this act shall be cognizable and non bailableoffences to be cognizable and non-bailable offences by companies11 where a person committing a contravention of any of the provisions of this act or of any rule 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 guilty of the contravention and shall be liable to be proceeded against and punished accordingly:provided that nothing contained in this sub-section shall render any such person liable to punishment if he proves that the contraventioin took place without his knowledge or that he exercised all due diligence to prevent such contraventionexplanation—for the purpose of this section:—(i) "company" means any body corporate and include a firm or other association of individuals; and(ii) "director", in relation to a firm, means a partner in the firmsummary trial12 all offences under this act shall be tried summarily in the manner prescribed for summary trial under the code of criminal procedure act, 1973power to remove difficulties13 if any difficulty arises in giving effect to the provisions of this act, the central government 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:provided that no such orders shall be made after the expiry of the period of threeyears from the date of commencement of this actoverriding effect14 the provisions of this act shall be in addition to, and not in derogation of, theprovisions in any other law, for the time being in force, relating to herbal medicinespower to make rules15 the central government may, by notification in the official gazette, make rulesfor carrying out the purposes of this act statement  of  objects  and  reasonsof late, the herbal medicines have acquired a significant role in treating various kind of diseases in the country the market is flooded with all kinds of traditional and herbal medicines some of these herbal medicines are imported from various neighbouring countries which are claimed to be made of various parts of tiger or some other animal or their formulations are based on ancient text in their countries there are reports that many of these medicines are containing steroids and heavy metals which are very harmful to human bodysimilarly, advertisement of these medicines is also a big business the broadcaster without realising the side effects of various herbal drugs which are meant to reduce weight or increase height or sexual desire, advertise them in their channel for earning moneythe laws in our country is such that if someone says that formulation of his medicine is based on the ancient text he does not require any licence to sell and produce that medicine the unscrupulous elements in the society are making use of this loophole in the law and are producing and selling spurious herbal medicines without any licencealthough there are many reputed and good companies which are producing and selling class products of herbal medicines but then there are many fly by night operators who are fleecing the innocent peoplemany countries in the world have banned these herbal drugs which claim to reduce weight, increase height, grow hair, etc when they detected harmful elements in those drugstherefore, there is an urgent need to have a law on the regulation of sale, production, supply, distribution and advertisement of herbal drugs to save the citizens from their harmful effectshence this billmahendra mohan memorandum  regarding  delegated  legislationclause 15 of the bill empowers the central government to make rules for carrying out the purposes of the bill as the matter will relate to details only, the delegation of powers is of normal character———— a billto provide for regulation of production, distribution, sale and advertisement of herbal medicines in the country and for matters connected therewith or incidental thereto————(shri  mahendra  mohan,  mp)mgipmrnd—1221rs (s5)—16-03-2007