 bill no 254 of 2016 the drugs and cosmetics (amendment) bill, 2016 by shri maheish girri, mp a billfurther to amend the drugs and cosmetics act, 1940be it enacted by parliament in the sixty-seventh year of the republic of india as follows:—1 (1) this act may be called the drugs and cosmetics (amendment) act, 2016short title and commencement5(2) it shall come into force on such date as the central government may, by notification in the official gazette, appointamendment of section 223 of 19402 in section 2 of the drugs and cosmetics act, 1940 (hereinafter referred to as the principal act),—(i) the existing clause (aaa) shall be renumbered as clause (aab) and before clause (aab) as so renumbered, the following clause shall be inserted, namely:—10"(aaa) "central authority" means the central authority for regulation,control, registration and licensing of e-pharmacies constituted under section 33-ob;"; (ii) after clause (b), the following clause shall be inserted, namely:—1523 of 1940"(ba) "e-pharmacy" refers to an online pharmacy of a company or a hospitalor a dispensary which through internet dispense with or sell drugs or compound medications in accordance with the drugs and cosmetics act, 1940;";(iii) after clause (h), the following clause shall be inserted, namely:—"(ha) "prescription" includes the name of the doctor and hospital or clinic, details of the disease, drugs prescribed and any other relevant information;"; and5(iv)  after clause (i), the following clause shall be inserted, namely:—"(j) "state authority" means the state authority for regulation, control, registration and lincensing of e-pharmacies constituted under section 33-od"3 after section 33-o of the principal act, the following chapter and section thereunder shall be inserted, namely:—10 "chapter ivb regulation, control, registration and licensing of e-pharmaciescompulsory registration of e-pharmacies1533-oa with effect from such date as the central government may, by notification in the official gazette, appoint, no person or establishment shall operate or own an e-pharmacy without prior registration with the central authority or the state authority, as the case may be:20provided that every person or establishment, operating or owning an e-pharmacy prior to the coming into force of this act, shall apply to the central authority or the state authority, as the case may be, for registration within a period of ninety days from the date of commencement of this act in such form and manner as may be prescribed33-ob (1) the central government shall, by notification in the official gazette, constitute an authority to be known as the central authority for regulation, control, registration and licensing of e-pharmacies in such manner as may be prescribed25(2) the central government shall appoint such number of officers and staff, as it considers necessary, for the efficient functioning of the central authorityconstitution of central authority for regulation, control, registration and licensing of e-pharmacies33-oc the central authority shall—functions of central authority(a) frame guidelines in consultation with the central drugs standard control organisation for the purpose of registration and licensing of e-pharmacies;30(b) recommend to the central government the rules and the regulations tobe framed for regulation, control, registration and licensing of e-pharmacies in the country; and(c) undertake such other functions as may be assigned to it by the central government for carrying out the purposes of this act3533-od (1) every state government shall, by notification in the official gazette, constitute an authority to be known as the state authority for regulation, control, registration and licensing of the e-pharmacies within its jurisdiction in such manner as may be prescribed40(2) the state government shall appoint such number of officers and staff, as it considers necessary, for the efficient functioning of the state authorityconstitution of state authority for regulation, control, registration and licensing of e-pharmacies33-oe the state authority shall—functions of  state authority(a) ensure the implementation of the guidelines framed by the central authority under section 33-oc;(b) appoint such number of drug controllers being not less than one toensure that the documents and provisions required for e-pharmacies are being complied with by the e-pharmacies;5(c) maintain an offline and online database of all licensed e-pharmacieswithin its jurisdiction;(d) work in coordination with the central authority constituted undersection 33-ob for effective implementation of the provisions of this act;(e) make regular inspections of the website of the e-pharmacies; and10(f) undertake such other functions as may be assigned to it by the stategovernment for carrying out the purposes of this act33-of for the purposes of registration under this act, every e-pharmacy shall submit the following documents to the central authority or the state authority, as the case may be,—documents required forregistration of e-pharmacies(a) application form;15(b) challan or receipt of the fee deposited; (c) declaration form; (d) key plan or the blue print; (e) site plan or the blue print; (f) certified copy of the constitution of the firm;20(g) affidavit of non-conviction of proprietor or partners or directors underdrugs and cosmetics act, 1940;23 of 1940(h) certified copy of  registration certificate of pharmacy council of indiaor experience certificate of the registered pharmacist or competent person and qualification certificates;25(i) bio-data form; (j) affidavit of registered pharmacist or competent person regarding fulltime working with the firm duly attested by a notary; and(k) the name and details thereof of the online portal of the e-pharmacy30grant of license to e-pharmacy33-og the central authority or the state authority shall, in accordance with thereport submitted by the central drugs standard control organisation or drug controller, as the case may be, and after detailed inspection of the documents grant the license to the e-pharmacy33-oh (1) no e-pharmacy shall sell or supply drugs except in accordance withthe prescription of a registered medical practitioner35conditions for sale and supply of drugs by e-pharmacy(2) for the purposes of sub-section (1), the scanned copy of the prescriptionduly signed and stamped by the registered medical practitioner shall be uploaded on the website of the e-pharmacy which shall be verified by the pharmacist of the e-pharmacy in such manner as may be prescribed:provided that only one prescription shall be valid for one online order of drugs" statement of objects and reasonsmushrooming of e-commerce websites for every commodity and services of daily use has become quite evident today now-a-days, various e-commerce websites are also selling medicines online however, there is no law to govern the functioning of these online pharmacies due to various exploitative practices that can take place for the purpose of drug-abuse, regulatory framework needs to be set up to ensure that the practices carried on by these sites are not contrary to the parent act ie the drugs and cosmetics act, 1940the bill, therefore, seeks to amend the drugs and cosmetics act, 1940 with a view to provide for—(a) compulsory registration of the e-pharmacies in the country; (b) constitution of the central authority and the state authority for regulation,control, registration and licensing of e-pharmacies;(c) documents required for registration of e-pharmacies in the country; (d) grant of license to e-pharmacies in the country; and (e) conditions for sale and supply of drugs by e-pharmacieshence this billnew delhi;maheish girrijuly 6, 2016 financial memorandumclause 3 of the bill provides for the constitution of central authority for regulation, control, registration and licensing of e-pharmacies it also provides for the constitution of state authority for regulation, control, registration and licensing of e-pharmacies it further provides for appointment of drug controllers being not less than one and maintenance of an offline and online database of all licensed e-pharmacies by the state government within its jurisdiction the expenditure relating to states shall be borne from the consolidated funds of the respective states however, the expenditure relating to union territories shall be borne by the central government the bill, therefore, if enacted, would involve expenditure from consolidated fund of india it is estimated that a recurring expenditure of rupees twenty five crore will be involved per annuma non-recurring expenditure of twenty five crore is also likely to be involved memorandum  regarding  delegated  legislationclause 3 of the bill provides that every person or establishment, operating or owning an e-pharmacy prior to the coming into force of this act, shall apply for registration within a period of ninety days from the date of commencement of this act to the central authority or the state authority, as the case may be, in such form and manner as may be prescribed it also provides that the central government shall, by notification in the official gazette, constitute a central authority for regulation, control, registration and licensing of e-pharmacies in such manner as may be prescribed it further provides that every state government shall, by notification in the official gazette, constitute an authority to be known as the state authority for regulation, control, registration and licensing of the e-pharmacies within its jurisdiction in such manner as may be prescribed it furthermore provides that the scanned copy of the prescription duly signed and stamped by the registered medical practitioner shall be uploaded on the website of the e-pharmacy which shall be verified by the pharmacist of the e-pharmacy in such manner as may be prescribed by rules made by the central government or the state government, as the case may be as the rules will relate to matters of detail only, the delegation of legislative power is of a normal character annexure extract from the drugs and cosmetics act, 1940 (no 23 of 1940)      definitions3 in this act, unless there is anything repugnant in the subject or context,—      (aaa) "cosmetic" means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic;       (b) "drug" includes—(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the central government by notification in the official gazette;(iii) all substances intended for use as components of drug including empty gelatin capsules; and(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central government by notification in the official gazette, after consultation with the board:     (h) "patent or proprietary medicine" means,—(i) in relation to ayurvedic, siddha or unani tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of ayurveda, siddha or unani tibb systems of medicine specified in the first schedule but does not include a medicine which is administered by parental route and also a formulation included in the authoritative books as specified in clause (a);(ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the indian pharmacopoeia for the time being or any other pharmacopoeia authorised in this behalf by the central government after consultation with the drugs technical advisory board constituted under section 5; (i) "prescribed" means prescribed by rules made under this act     ———— a billfurther to amend the drugs and cosmetics act, 1940————(shri maheish girri, mp)gmgipmrnd—2657ls(s3)—08-11-2016