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Latest National News : Clinical trial rules under SC scanner
The Centre’s policy on clinical trials in the country has come under the scanner of the Supreme Court. On Monday, the SC issued a notice to the Centre as also to the Health Ministry and the Medical Council of India (MCI) to reply on conducting an independent probe into alleged illegal clinical trials of untested drugs by pharma firms in various States.
A Bench of justices RM Lodha and HL Gokhale had taken cognisance of a Public Interest Litigation (PIL) filed by Indore-based NGO Swasthya Adhikar alleging that the country is being used for illegal clinical trials by the MNCs because laws are not implemented strictly.
“India is being used for conducting clinical trials by the multinational corporation owing to the reason that the laws are not implemented strictly, because of legal lacunae and because of poverty and other economic reasons the subjects for these trials are easily available,” said advocate Sanjay Parekh, appearing for the petitioner.
Seeking appointment of an expert panel to regulate the clinical trials done by many multinational pharma majors, the petitioner pointed out various cases of illegal drug trials being going on in the country and that they must be stopped at the earliest.
The NGO submitted in its petition that the interests of patients are not safeguarded in these trials and their consent is also not taken while independence of the ethical committees is compromised ignoring the interests of patients.
“In India, illegal clinical trials are taking place because of lax regulations and their flawed implementation,” it said. The PIL has come amidst the recent allegations of negligence during the trial of a human papilloma virus (HPV) vaccine in Andhra Pradesh, where four girls died after being vaccinated. While, the ICMR halted the trials, experts are still investigating the cause of the deaths.
The petitioner further said, “the doctors often receive benefits from the trial sponsors which sometimes become the main source of their income, creating a glaring conflict of interest.
Welcoming the Court’s move, Dr Chandra M Gulhati, editor of the Monthly Index of Medical Specialties noted, if there is any violation of the protocol by the hospital where the trial is being conducted or by the sponsor, the drug controller can either suspend or stop the trial midway and order an inquiry. However, there is no provision for punishment of any kind for those who violate the guidelines.
The Centre’s policy on clinical trials in the country has come under the scanner of the Supreme Court. On Monday, the SC issued a notice to the Centre as also to the Health Ministry and the Medical Council of India (MCI) to reply on conducting an independent probe into alleged illegal clinical trials of untested drugs by pharma firms in various States.
A Bench of justices RM Lodha and HL Gokhale had taken cognisance of a Public Interest Litigation (PIL) filed by Indore-based NGO Swasthya Adhikar alleging that the country is being used for illegal clinical trials by the MNCs because laws are not implemented strictly.
“India is being used for conducting clinical trials by the multinational corporation owing to the reason that the laws are not implemented strictly, because of legal lacunae and because of poverty and other economic reasons the subjects for these trials are easily available,” said advocate Sanjay Parekh, appearing for the petitioner.
Seeking appointment of an expert panel to regulate the clinical trials done by many multinational pharma majors, the petitioner pointed out various cases of illegal drug trials being going on in the country and that they must be stopped at the earliest.
The NGO submitted in its petition that the interests of patients are not safeguarded in these trials and their consent is also not taken while independence of the ethical committees is compromised ignoring the interests of patients.
“In India, illegal clinical trials are taking place because of lax regulations and their flawed implementation,” it said. The PIL has come amidst the recent allegations of negligence during the trial of a human papilloma virus (HPV) vaccine in Andhra Pradesh, where four girls died after being vaccinated. While, the ICMR halted the trials, experts are still investigating the cause of the deaths.
The petitioner further said, “the doctors often receive benefits from the trial sponsors which sometimes become the main source of their income, creating a glaring conflict of interest.
Welcoming the Court’s move, Dr Chandra M Gulhati, editor of the Monthly Index of Medical Specialties noted, if there is any violation of the protocol by the hospital where the trial is being conducted or by the sponsor, the drug controller can either suspend or stop the trial midway and order an inquiry. However, there is no provision for punishment of any kind for those who violate the guidelines.
