 bill no  15 of  2018 the drugs and cosmetics (amendment) bill, 2018 by shrimati kavitha kalvakuntla, mp a billfurther to amend the drugs and cosmetics act, 1940be it enacted by parliament in the sixty-ninth year of the republic of india as follows:—1  (1) this act may be called the drugs and cosmetics (amendment) act, 2018short title and commencement5(2) it shall come into force on such date as the central government may, by notificationin the official gazette, appoint23 of 19402 in the drugs and cosmetics act, 1940, after chapter iii, the following chapter shallbe inserted, namely:—insertion of new chapter iiia "chapter iiia clinical trials of drugs10constitution of accreditation board15a (1) the central government shall, by notification in the official gazette,constitute a board to be known as the clinical trials accreditation board which consists of the following members, namely:—(a) secretary to the government of india, ministry of health and family welfare, department of health and family welfare—chairperson, ex-officio;(b) directors of all all-india institutes of medical sciences—members, ex-officio; (c) director-general of health services, directoratre general of  health services, new delhi—members, ex-officio;5(d) director, post graduate institute of medical education and research, chandigarh—member, ex-officio;(e) director, post graduate institute of medical education and research, new delhi—member, ex officio; and10(f) director, jawaharlal institute of post graduate medical education and research, puducherry—member, ex-officio; (2) the accreditations board shall accredit investigators and trial sites for conduct of clinical trial of drugs15(3) the accreditation board shall appoint a registrar to maintain a registry of clinical trials and their outcomes(4) the accreditation board shall constitute a committee of experts to examine applications for conduct of clinical trials by accredited investigators(5) the accreditation board shall appoint such officers and staff as are necessary for discharge of its functions under this act20conduct of clinical trials15b (1) a clinical trial shall be conducted only by an accredited investigator entity atan accredited trial site(2) an accredited investigator shall apply to the committee of experts for permission to conduct clinical trials25(3) each such application shall be examined by the committee of experts, with specialreference to, but without prejudice to examination of any other aspect that may be relevant, the possibility of serious adverse consequences for human subjects, existence of free and informed consent of human subjects and the provisions for adequate compensation in thecase of any injury or adverse effect on such subjects due to the clinical trial(4) the committee of experts shall give its decision on an application for clinical trialwithin sixty days:30provided that the accreditation board may, for reasons to be recorded in writing,reverse the decision of the committee of experts within a period of ten days from the date of decision of the committee of expertsinformed consent15c every human subject participating in a clinical trial shall be informed about theentire procedure of clinical trial and the possible adverse effects of such trial on his health:35provided that unless an application for clinical trial is accompanied by adeclaration of free and informed consent made by such human subject, no permission for clinical trial shall be grantedcompensation4015d every human subject participating in a clinical trial or his legal heirs, as the casemay be, shall be paid adequate monetary compensation in the case of any adverse effect on his health during the course of a clinical trial or as an after-effect of the trial:provided that in the case of death of the human subject or a serious adverseeffect on his health causing permanent disability, the compensation shall not be less than ten lakh rupeespenalty for conducting clinical trial without permission15e (1) whoever, himself or by any other person on his behalf, conducts clinical trial of drugs without obtaining permission under section 15b, shall be punished with imprisonment for a term which shall not be less than three years and shall also be liable to fine which shall not be less than twenty lakh rupees5(2) whoever, himself or by any other person on his behalf, conducts clinical trialwithout obtaining permission and such trial causes grievous hurt or death of trial participant, shall be punished with imprisonment for a term which shall not be less than five years but which may extend to eight years and shall also be liable to fine which shall not be less than thirty lakh rupees10(3) the fine imposed under this section shall be paid to the trial participant or, as thecase may be, his legal heirspenalty for repeatoffence15f whoever, having been convicted of an offence under section 15e is again convictedunder that section, shall be punished with imprisonment for a term which shall not be less than ten years and shall also be liable to fine which shall not be less than fifty lakh rupees15penalty for failure to provide compensation15g whoever, responsible to provide compensation for clinical trial related injury ordeath under this chapter fails to do so, shall be punished with imprisonment which may extend to three years and with fine which shall not be less than twice the amount of the compensationoffences by companies2015h where an offence under this act has been committed by a company, every person who at the time the offence 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 deemed to be guilty of the contravention and shall be liable to the proceeded against and punished accordingly:25provided that nothing in this sub-section shall render any such person liable to any punishment provided in this act, if he proves that the offence was committed without his knowledge or that he exercised due diligence to prevent the commission of such offenceexplanation—for the purpose of this section—30(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 firm" statement of objects  and reasonsindia has been a major target for investigators seeking human subjects for clinical trials of drug both by multi-national corporations as well as indian pharmaceutical companies the high mortality rates and serious adverse effects on the health of human subjects have often been considered indicative of the fact that human subjects in clinical trials are being treated as guinea pigs in india the fact that in many cases no compensation is paid and, even where it is paid, it is not sufficient relative to the injury suffered by the human participant due to the clinical trial, shows the lack of sensitivity for such casesin view of the above, the bill seeks to make the following amendments in the drugs and cosmetics act, 1940—(i) providing for establishment of an accreditation board for granting accreditation to investigators (who will conduct trials) and trials sites (which can be a hospital or other place where the trial will be conducted);(ii) constitution of a committee of experts to examine applications for clinical trials;(iii) appointment of a registrar for keeping registry of clinical trials and their outcomes;(iv) providing for mandatory free and informed consent from human subjects participating in clinical trials and provision of adequate compensation for injuries or death due to such trials; and(v) providing for punishment for conduct of clinical trials without permission and for failure to provide compensationhence this billnew delhi;kavitha  kalvakuntladecember  18, 2018 financial memorandumclause 2 of the bill provides for constitution of an accreditation board, a committee of experts, and appointment of a registrar and other officers and staff of the accreditation board the bill, therefore, if enacted, would involve expenditure from the consolidated fund of india it is estimated that a recurring expenditure about rupees seven crore will be involved per annuma non-recurring expenditure of about rupees thirty crore is also likely to be involved lok  sabha———— a billfurther to amend the drugs and cosmetics act, 1940————(shrimati kavitha kalvakuntla, mp)gmgipmrnd—3631ls(s3)—20012018