 bill no lxxxviii of 2006 the clinical trial of drugs on patients (regulation) bill, 2006 a billto provide for regulation of increasing clinical trials of various new drugs on patientsbeing 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 fifty-seventh year of the republic of india as follows:—1  (1) this act may be called the clinical trial of drugs on patients (regulation) act,2006short title, extent and commencement(2) it shall come into force with immediate effect5definitions2 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;(b) "fund" means clinical trial fund created under section7; (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 453 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 actpharmaceutical companies not to undertake clinical trial without registration104 (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 drugsregistry(2) the registry shall be headed by a registrar and shall have such number of officers and employees as may be specified and provided to it by the central government(3) the headquarters of the registry shall be at lucknow15(4) the 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 willing to conduct clinical trial of any drug in the country shall make an application for the registration of clinical trial to the registry in such form and in  such manner as may be prescribed:20provided that the pharmaceutical companies which are conducting clinical trials in the country shall apply for registration of the clinical trial with the registry within one month of the commencement of this act (2) the registry shall, within one month of the filing of the application under subsection (1), either register the trial after verifying the fulfillment of the requirements under the provisions of this act or reject the application25(3) while rejecting any application for clinical trial under sub-section (2), the registry shall give the reasons in writing to the concerned pharmaceutical company6 (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 trial30(2) every patient undergoing clinical trial shall be paid fifty thousand rupees by thepharmaceutical company conducting or outsourcing the trial of drugs before starting the trial(3) the hospital conducting the clinical trial shall ensure that the trial is conducted by the trained and qualified persons and ensure for its proper monitoring35clinical trial fund7 (1) the central government, shall  by notification in the official gazette, constitutea clinical trial fund for the welfare of the family of the person and the person himself in case the trial goes wrong40(2) the fund shall consist of such sums of money as may be contributed in it by thecentral 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 beprescribed8  in case the trial goes wrong, it shall be the responsibility of the hospital conducting the clinical trial to record and find out the reasons and fix the responsibility:hospital to record andfind reasons if trial goes wrong5provided that if the trial goes wrong due to negligence, the patient or his immediatefamily shall be entitled to claim damages from the hospital or pharmaceutical company, as the case may be9 the central government shall, after due appropriation made in this behalf, provide such sums of money as it may think fit for being utilized for the purposes of this actcentral government to provide funds penalty1010 whoever contravenes or attempts to contravene or abets the contravention of the provisions of this act shall be punishable with imprisonment  for  a term, which may extend to three years or with fine, which may extend to twenty lakhs rupees or with bothoffences 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:15provided that nothing contained in this sub-section shall render any such person liable to punishment if he proves that the contravention took place without his knowledge or that he exercised all due diligence to prevent such contravention explanation— for the purpose of this section;—20(i) "company" means any body corporate and include a firm or other associationof individuals; and(ii) "director", in relation to a firm, means a partner in the firmpower to remove difficulties2512 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 difficult:provided that no such order shall be made after the expiry of the period of three years from the date of commencement of this actoverriding effect13 the provisions of this act shall be in addition to, and not in derogation of, the provisions in any other law, for the time being in force, relating to clinical trial of drugs30power to make rules14 the central government may, by notification in the official gazette, make rules forcarrying out  the purposes of this act 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 manufatured 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 expected to touch rupees two thousand crores it has been further stated in the study that in the next two years thirty 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 last year, nearly 175 trials were conducted  in the country  these trials are not limited to multinational companies but also to indian pharma companies which are also contracting 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 the 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 promisesin the recent past, over 430 unsuspecting 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 concent 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 pharmceutical 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 affortit 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 ugent need for regulation on this aspect covering the various aforesaid propositionshence this billmahendra mohan financial memorandumclause 4 of the bill provides the establishment of the clinical  trial of drugs registry, clause 7 of the bill provides that the central government shall contribute money to clinical trial fund further, clause 9 provides that central  government shall provide funds for being utilized for the purpose of this act the bill, if enacted, involve expenditure from the consolidated fund of india to the tune of rupees twenty crore per annum no non-recurring expenditure is 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 matter will relate to details only, the delegation of powers  is of normal character————— a billto provide for regulation of increasing clinical trials of various new drugs on patients beingconducted 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 thereto————(shri mahendra mohan, mp)