Clinical trial: India an easy target for foreign drug companies

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first_imgIt is not just the inexpensive, world class medical facilities which attract foreigners to India. The country has emerged as a hotspot for foreign drug companies, which unhesitatingly flout all rules and regulations to test their products.This blatant violation of norms and ethics while conducting clinical trials is largely because of lax rules and absence of provisions for effective monitoring during each stage of the trial.According to an estimate, the value of clinical trials in India stood at Rs 1,500 crore in 2010 and can touch Rs 2,760 crore by 2012.All clinical trials, approved by the Drug Controller General of India (DCGI), must be noted in the Clinical Trial Registry of India, launched in 2007.However, the registry only gives information on the purpose of the trial, the number of people participating in the trial, the date on which it will start and end, and the places or sites where the trial will be conducted.”There is no mechanism to monitor clinical trials,” Dr C. M. Gulati, editor, Monthly Index of Medical Specialities, said.”After approval by the DCGI, a trial has to be approved by an ethics committee. But, there are no guidelines on who can set it up. This has resulted in random manipulations and inducements where approvals for clinical trials are being given for Rs 25,000 while sites for conducting the trials are being added in the registry by paying Rs 5,000 per site,” Gulati said.Though the Indian Council of Medical Research (ICMR) has framed guidelines on conducting clinical trials on humans, a draft bill on the guidelines is yet to be examined before it is tabled in Parliament.advertisementThere are a number of areas where rules are flouted while conducting a clinical trial.It all begins with the filing of the consent forms. There have been cases where the consent of the participant was not taken, or where the consent form has been filled by a person other than the participant, or where the forms have been filled incorrectly.In such cases, it becomes difficult to trace those who participated in the trial.Also, the testing of foreign drugs has become much easier in India after changes were made to the Drugs and Cosmetics Rules in 2005.Earlier, the rules required a “phase lag” in the testing of drugs. Thus, if Phase III study had been completed elsewhere, Phase II study was permitted in India.This was done to protect Indians from being used as guinea pigs in the testing of unproved drugs of foreign origin.With the change of rules, Phase II or III trial can be conducted concurrently, even if the drug has not undergone a Phase I or II trial in India.The change was ostensibly made in response to demands from multinational drug companies and private organisations that conduct clinical research.That these clinical trials often prove lethal can be gauged from the fact that there have been 1,514 deaths over the past 28 months.Laxity of norms governing these trials has resulted in gross injustice to the poor as the drug companies have accepted only 25 cases where death was caused because of the trial.Moreover, compensation has been given only in five cases, with the maximum amount being Rs 3 lakh.”There are lots of concerns on the ethical aspects of clinical trials. The proposed law will clear issues such as consent forms, post trial benefits and compensation to participants in case of adverse events. Though the current law talks of compensation, it does not specify the details,” Dr Vasantha Muthswamy, former senior director general of ICMR, said.”Clinical trials have now emerged as a business opportunity and lucrative way to make money for researchers,” Gulati said.For more news on India, click here.For more news on Business, click here.For more news on Movies, click here.For more news on Sports, click here.last_img

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