THE DRUGS AND COSMETICS (AMENDMENT) …

1 1 THE DRUGS AND COSMETICS ( amendment ) BILL, 2013 ABILL further to amend the DRUGS and COSMETICS Act, it enacted by Parliament in the Sixty-fourth Year of the Republic of India as follows: 1. (1) This Act may be called the DRUGS and COSMETICS ( amendment ) Act, 2013.(2) It shall come into force on such date as the Central Government may, by notificationin the Official Gazette, appoint:Provided that different dates may be appointed for different provisions of this Act, andany reference in any such provision to the commencement of this Act shall be construed asa reference to the coming into force of that In the DRUGS and COSMETICS Act, 1940 (hereinafter referred to as the principal Act),for the long title and first paragraph of the preamble, the following shall be substituted,namely: An Act to regulate the import, export, manufacture, distribution and sale ofdrugs, COSMETICS and medical devices to ensure their safety, efficacy, quality andconduct of clinical trials and for matters connected therewith or incidental title long titleand of INTRODUCED IN THE RAJYA SABHABill No.

2 LVIII of 20135102 WHEREAS it is expedient to regulate the import, export, manufacture, distributionand sale of DRUGS , COSMETICS and medical devices to ensure their safety, efficacy, qualityand conduct of clinical trials and for matters connected therewith or incidental thereto..3. In section 1 of the principal Act, in sub-section (1), for the words and COSMETICS ,the words , COSMETICS and Medical devices shall be Throughout the principal Act, for the word Inspector , wherever it occurs, thewords DRUGS Control Officer shall be In section 2 of the principal Act, for the words and figures the Dangerous DrugsAct, 1930 , the words and figures the Narcotic DRUGS and Psychotropic Substances Act,1985 shall be In section 3 of the principal Act, (i) after clause (a), the following clauses shall be inserted, namely: (aA) bioavailability study means a study to assess the rate and extentto which the active drug is absorbed from a pharmaceutical formulation andbecomes available in the systemic circulation or availability of drug at the site ofaction.

3 (aB) bioequivalence study means a study to establish the absence of asignificant difference in the rate and extent of absorption of an active drug froma pharmaceutical formulation in comparison to the reference formulation havingthe same active drug when administered in the same molar dose under similarconditions; ;(ii) in clause (aa), after sub-clause (ii), the following sub-clause shall be inserted,namely: (iii) in relation to Medical devices , the Medical Device Technical AdvisoryBoard constituted under section 5A; ;(iii) after clause (aa), the following clauses shall be inserted, namely: (ab) Central DRUGS Authority means the Central DRUGS Authority ofIndia constituted under sub-section (1) of section 4A;(ac) Central DRUGS Laboratory means a drug testing laboratoryestablished by the Central Government, by whatever name, for carrying out thefunctions assigned to it under this Act and rules made thereunder;(ad) Central Licensing Authority means the DRUGS Controller General ofIndia designated as such under sub-section (2) of section 4J;(ae) Chairperson means the Chairperson of the Central DRUGS Authority;(af) clinical trial means (i) in respect of DRUGS , any systematic study of new drug ,investigational new drug or bioavailability or bioequivalence study ofany drug in human subjects to generate data for discovering or verifyingits clinical, pharmacological (including pharmacodynamic andpharmacokinetic) or adverse effects with the objective of determining safety,efficacy or tolerance of the drug .

4 (ii) in respect of COSMETICS , the systematic study, includingdermatological study, of a cosmetic including a new cosmetic on humansubjects to generate data for discovering or verifying its adverse effectswith the objective of determining safety, efficacy or tolerance of thecosmetic;Amendmentof section ofwords DrugsControl Officer forword Inspec-tor .Amendmentof section of of section (iii) in respect of medical devices , the systematic clinicalinvestigation or study of a medical device, investigational medical deviceor a new medical device, in, or on human subjects to assess the safety orperformance of the medical device; ;(iv) in clause (aaa), after the words component of cosmetic , the words andincludes new cosmetic shall be inserted;(v) in clause (b), (A) in sub-clause (ii), after the words destruction of vermin or insects ,the words or microbes shall be inserted;(B) sub-clause (iv) shall be omitted;(C) after sub-clause (iv), the following sub-clause shall be inserted,namely: (v) any new drug for which permission has been granted by theCentral Licensing Authority under the first proviso to clause (c) ofsub-section (1) of section I.

5 In this sub-clause, new drug means (i) a drug , including bulk drug substance, which has not beenused in the country to any significant extent under the prescribedconditions, recommended or suggested in the labelling thereof andhas not been recognised as effective and safe by the CentralLicensing Authority for the expected claims and its limited use, ifany;(ii) a drug approved by the Central Licensing Authority forcertain claims, which is proposed to be marketed with modified ornew claims, namely, indications, dosage, dosage form (includingsustained release dosage form) and route of administration;(iii) a fixed dose combination of two or more DRUGS ,individually approved earlier for certain claims, which are proposedto be combined for the first time in a fixed ratio, or if the ratio ofingredients in a marketed combination is proposed to be changed,with certain claims, namely, indications, dosage, dosage form(including sustained release dosage form) and route ofadministration;(iv) all vaccines, recombinant Deoxyribonucleic Acid derivedproducts, Living Modified Organisms, monoclonal anti-bodies, stemcells, gene therapeutic products and xenografts which are intendedto be used as DRUGS ;Explanation II.

6 A new drug shall continue to be a new drug forsuch period as may be prescribed except the type of new drug specified inclause (iv) of Explanation I which shall always remain a new drug ; ;(vi) after clause (b), the following clauses shall be inserted, namely: (ba) DRUGS Control Officer means (i) in relation to Ayurvedic, Siddha or Unani drug , a DRUGS ControlOfficer appointed by the Central Government or a State Government undersection 33G;(ii) in relation to any other drug or cosmetic , a DRUGS Control Officer510152025303540454appointed by the Central DRUGS Authority or a State Government undersection 21;(iii) in relation to any medical device, the Medical Device Officerappointed by the Central DRUGS Authority under section 7H;(bb) DRUGS Controller General of India means an officer appointed bythe Central Government under sub-section (1) of section 4G;(bc) Ethics Committee means the Ethics Committee constituted undersection 4T; ;(vii) in clause (c), in sub-clause (ii), for the words Central Government , thewords Central DRUGS Authority shall be substituted;(viii) after clause (c), the following clauses shall be inserted, namely: (d) Indian Pharmacopoeia means the official book of standards fordrugs which specifies the standards of identity, purity and strength for thedrugs mentioned therein;(da) investigational medical device means a device, which is an objectof a clinical investigation or research or development involving one or moresubjects to determine the safety or effectiveness of a device.

7 (db) investigational new drug means chemical entity or substance whichis under investigation in clinical trial regarding its safety and efficacy and whichis required to be approved by the Central DRUGS Authority;(dc) investigator means a person who is responsible for the conduct ofa clinical trial and responsible for the rights, health, safety and well being of thestudy subjects on the study site; ;(ix) clause (e) shall be omitted;(x) for clause (f), the following clause shall be substituted, namely: (f) manufacture means (i) in relation to any drug (except human blood and its components,or any cosmetic ) includes any process or part of a process for making,altering, ornamenting, finishing, packing, labelling, breaking up orotherwise treating or adapting any drug or cosmetic with a view to itssale, export, stocking or distribution but does not include the compoundingor dispensing of any drug , or the packing of any drug or cosmetic , in theordinary course of retail business;(ii) in relation to human blood and its components includes anyprocess or part of a process of collection, processing, storage, packing,labelling and testing for its use, sale, export or distribution for transfusionin human beings.

8 (iii) in relation to any medical device, includes any process or partof process for making, assembling, altering, ornamenting, finishing,packing, labelling, or adapting any medical device with a view to its sale orstock or export or distribution but does not include assembling or adaptinga device already on the market for an individual patient; ;(xi) after clause (f), the following clauses shall be inserted, namely: (fa) medical device means (i) any instrument, apparatus, appliance, implant, material or otherarticle, whether used alone or in combination, including the software,510152025353040455intended by its manufacturer to be used specially for human beings oranimals for one or more of the specific purposes of, (A) diagnosis, prevention, monitoring, treatment or alleviationof any disease or disorder;(B) diagnosis, monitoring, treatment, alleviation of, orassistance for, any injury or handicap;(C) investigation, replacement or modification or support ofthe anatomy or of a physiological process;(D) supporting or sustaining life;(E) disinfection of medical devices ;(F) control of conception,and which does not achieve its primary intended action in or on the humanbody or animals by any pharmacological or immunological or metabolicmeans, but which may be assisted in its intended function by such means;(ii) an accessory to such an instrument, apparatus, appliance, materialor other article.

9 (iii) a device which is reagent, reagent product, calibrator, controlmaterial, kit, instrument, apparatus, equipment or system whether usedalone or in combination thereof intended to be used for examination andproviding information for medical or diagnostic purposes by means of invitro examination of specimens derived from the human body or animals;(iv) any new medical device;(fb) Member means a Member of the Central DRUGS Authority andincludes the Chairperson and the Member-Secretary; ;(xii) in clause (h), in sub-clause (ii), for the words Central Government , thewords Central DRUGS Authority shall be substituted;(xiii) after clause (i), the following clauses shall be inserted, namely: (j) protocol means a document that states the background, objectives,rationale, design, methodology (including but not limited to the methods fordealing with adverse events or withdrawals) and statistical considerations ofthe clinical trial and also states the conditions under which the trial shall beperformed and managed;(k) regulations means the regulations made by the Central DrugsAuthority under this Act;(l) sponsor means and includes an investigator, an individual or acompany or an institution responsible for the initiation, financing and managementof a clinical trial;(m) State Government includes the administrator of a Union territoryappointed by the President under article 239 of the Constitution.

10 (n) State Licensing Authority means an officer designated as such bythe State Government under sub-section (3) of section 7F or sub-section (2) ofsection 18;(o) Schedule means a Schedule appended to this Act; .51015202530354067. After Chapter I of the principal Act, the following Chapters shall be inserted, namely: CHAPTER IACENTRAL DRUGS AUTHORITY4A. (1) The Central Government shall, by notification in the Official Gazette,constitute an Authority to be known as the Central DRUGS Authority to exercise thepowers conferred on, and perform the functions assigned to it by or under this Act.(2) The Central DRUGS Authority shall be a body corporate by the name aforesaid,having perpetual succession and a common seal, with power to acquire, hold anddispose of property, both movable and immovable, and to contract, and shall, by the saidname, sue or be sued.(3) The head office of the Central DRUGS Authority shall be in the NationalCapital Region.