 bill no 300 of  2016 the clinical trial of drugs on patients (regulation) bill, 2016 byshrimati rama devi, mpa billto regulate clinical trials of various new drugs on patients being conducted by various pharmaceutical companies in the country to verify their clinical pharmacology or adverse effects; to determine their safety and efficacy; and to protect the interests of patients undergoing these trials in the absence of any information or contract by these companies and for matters connected therewith or incidental theretobe it enacted by parliament in the sixty-seventh year of the republic of india as follows:—definitions2 in this act, unless the context otherwise requires,—(a) "clinical trial" means the process of verifying the efficacy, safety and adverse effect of any new drug by pharmaceutical companies by testing it clinically on any patient with or without his consent;5(b) "fund" means clinical trial fund constituted under section 17; (c) "pharmaceutical company" means any establishment contracting or outsourcing clinical trials of any drug on patients;(d) "prescribed" means prescribed by rules made under this act; and (e) "registry" means clinical trial of drugs registry established under section 4103 no pharmaceutical company shall conduct or outsource any clinical trial of a drug on any patient unless such clinical trial is registered under the provisions of this actpharmaceuticalcompaniesnot to undertake clinical trial without registration4 (1) the central government shall, by notification in the official gazette, establish a registry to be known as the clinical trial of drugs registry for the purposes of performing functions assigned under this actestablishment of clinical trial of drugs registry15(2) the registry shall be headed by a registrar and shall have such number of officers and employees as may be appointed by the central government in such manner as may be prescribed(3) the headquarters of the registry shall be at lucknow20(4) the salary and allowances payable to and terms and conditions of service of the registrar, officers and employees of the registry shall be such as may be prescribedregistration of clinical trials5 (1) every pharmaceutical company shall, within the period of one month of  thecommencement of this act, make an application for the registration of clinical  trial to the registry in such form and in such manner as may be prescribed25(2) the registry shall, within one month of the filing of the application under sub-section (1), either register the trial after verifying the fulfillment of the requirements under the provisions of this act or reject the application(3) while rejecting any application for clinical trial under sub-section (2), the  registry shall give the reasons in writing to the concerned pharmaceutical company306 (1) every pharmaceutical company or hospital or medical practitioner before conducting clinical trial shall explain the whole process to the patient and obtain his consent in writingpatient to be paid and explained the process of clinical trial(2) every patient undergoing clinical trial shall be paid fifty thousand rupees by the pharmaceutical company conducting or outsourcing the trial of drugs before starting the trial35(3) the hospital conducting the clinical trial shall ensure that the trial is conducted bythe trained and qualified persons and ensure for its proper monitoringconstitution of clinical trial fund7 (1) the central government shall, by notification in the official gazette, constitutea clinical trial fund for the welfare of the patients undergoing clinical trial or their families in case the trial goes wrong40(2) the fund shall be credited with such sums of money as may be contributed to it bythe central government and the state governments and the donations received from various voluntary organizations and individuals(3) the central government shall administer the fund in such manner as may be prescribed8 in case the trial goes wrong, it shall be the responsibility of the hospital conductingthe clinical trial to record and find out the reasons and fix the responsibility:hospital to record and find reasons if trial goes wrong5provided that if the trial goes wrong due to negligence, the patient or his immediatefamily member shall be entitled to claim damages from the hospital or pharmaceutical company, as the case may be109 the central government shall, after due appropriation made by parliament by law in this behalf, provide such sums of money as it may think fit for being utilized for carrying out the purposes of this actcentral government to provide funds penalty10 whoever contravenes or attempts to contravene or abets in the contravention  ofthe provisions of this act shall be punishable with imprisonment for a term which may extend up to three years or with fine which may extend up to twenty lakhs rupees or with bothoffences by companies1511 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 including any director, manager, secretary or other officer of the company 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:20provided that nothing contained in this sub-section shall render any such personliable to punishment if he proves that the contravention took place without his knowledge or that he exercised all due diligence to prevent such contraventionexplanation— for the purpose of this section;—25(i) "company" means any corporate body and include a firm or other association of individuals; and(ii) "director", in relation to a firm, means a partner in the firmpower to remove difficulties3012 if any difficulty arises in giving effort 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 difficulties:provided that no such order shall be made after the expiry of the period of three yearsfrom the date of commencement of this actoverriding effect13 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 clinical trial of drugs35power to make rules14 (1) the central government may, by notification in the official gazette, make rulesfor carrying out the purposes of this act40(2) every rule made under this act shall be laid as soon as may be after it is made beforeeach house of the state legislature while it is in session for a total period of thirty days which may be comprised in one session or in two or more successive sessions and if, before the expiry of the session immediately following the session or successive sessions aforesaid both houses agree in making any modification in the rule or both houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under such rule statement of objects and reasonsin the near future, india is going to be the world's favourite destination for conducting clinical trials of various new drugs being manufactured by pharmaceutical giants in the world these major pharmaceutical companies are outsourcing the clinical trials in our country in a big way according to a study, the total market for clinical research activities in india is burgeoning it has been further stated in the study that in coming years a large per cent of global clinical trials will take place outside the us and western europe and india would be the most favoured country with the cut-throat competition, pharmaceutical companies are facing a lot of financial crunch due to spiraling research and development cost, and increasing overheads, therefore, outsourcing of clinical trial appears to be the viable option for them by contracting such work to india, these companies can save from forty to sixty per cent of the cost trials conducted in the country are not limited to multinational companies but also to indian pharma companies which are also conducting trial for research purposes in view of the new patent regime there is no doubt that if india has to participate in new drug development then clinical trials are essential because the general use of drugs have to be tested in a variety of ethnic groups or different genetic or race profiles though our country can take advantage of this situation but at the same time, there are concerns which show that indians are being used as guinea pigs for these clinical trials leading medical journals have noted how developing countries with poor and illiterate patients, weak legal framework, laxed bureaucracy and financially crunched hospitals have become hunting grounds for pharma giants to test new drugs the lucrative offers for trials are difficult to resist as they give plenty of money and promisesearlier young women were used as guinea pigs by researchers to test if anti-cancer drug letrozole could be used to increase ovulation according to a report published in monthly index of medical specialities in december, 2003, letrozole belongs to schedule g of the drugs and cosmetics rules and can be sold only against prescription but it was found out that many unauthorized practitioners had been prescribing and retailers selling the drug in another case, new chemical entities discovered in the us were unlawfully tested on 26 oral cancer patients at the regional cancer centre in thiruvananthapuram fairplay requires the patient undergoing clinical trial should be explained the whole process of the trial and his consent  may be obtained in writing but, with the kind of money involved in these trials nobody bothers about these things further, in case the trial goes wrong, there is no legal remedy available in our country and the law is silent about any compensation to be paid to the patient on whom the trial was conducted in us and uk, the patients on whom the trials are conducted are paid anywhere between two to three lakhs by the pharmaceutical companies but, in india, the poor illiterate patients are not paid a single paisa and rather are obliged by the doctor informing them that they are being treated by an imported drug free of charge which they cannot affordit is also required in these cases that the trained persons should undertake the job of clinical trial which should be closely supervised and monitored and responsibility should also be fixed if the trial goes wrong in view of the fact that extreme poverty and illiteracy make us susceptible to such trials and the law provides no assistance to the patients in conducting of clinical trials by pharma companies in our country, there is an urgent need for regulating this aspect covering the various aforesaid propositionshence this billnew delhi;rama  devinovember 4, 2016 financial memorandumclause 4 of the bill provides for the establishment of the clinical trial of drugs registry by the central government clause 7 provides for constitution of clinical trial fund clause 9 provides that central government shall provide funds for being utilized for the purpose of this act the bill, therefore, if enacted, would involve expenditure from the consolidated fund of india to the tune of rupees twenty crore per annuma non-recurring expenditure of about rupees ten crore is also likely to be involved memorandum regarding delegated legislationclause 14 of the bill empowers the central government to make rules for carrying out the purposes of the bill as the rules will relate to matters of detail only, the delegation of legislative power is of a normal character———— a billto regulate clinical trials of various new drugs on patients being conducted by variouspharmaceutical companies in the country to verify their clinical pharmacology oradverse effects; to determine their safety and efficacy; and to protect the interests ofpatients undergoing these trials in the absence of any information or contract bythese companies and for matters connected therewith or incidentalthereto————(shrimati rama devi, mp)gmgipmrnd—3318ls(s3)—29112016