Did V S Hospital follow CDSCO rules while conducting clinical trials?

Ahmedabad’s Sheth Vadilal Sarabhai Hospital has been embroiled in a controversy over clinical trials conducted by pharma companies allegedly without following due procedure.

According to the rules of the Central Drugs Standard Control Organisation (CDSCO),

• The age of the person participating in the trial must be between 28 and 50 years.
• It is mandatory to provide complete information about the drug’s side effects to the person.
• Written consent of the person participating in the trial is required.
• It is mandatory to provide details of the disease for which the drug trial is being conducted.
• It is mandatory to provide financial benefits to the person participating in the trial.
• The investigative trial is to be continuously monitored.
• If there are side effects from the drug, financial compensation must be given to the volunteer.
• It must be clearly stated how many times blood will be drawn and how many times the medicine will have to be taken.

However, V S Hospital did not follow the rules while conducting clinical trials, as per reports.

Moreover, pharmaceutical companies are also required to get permission for clinical trials from the Drug Controller General of India (DGCI). For clinical trials, it is also necessary to obtain a certificate stating whether the medicine is suitable for human use or not.

If the medicine belongs to a foreign company, then a Type-A certificate has to be obtained. After obtaining trial permission, trials can be conducted from 15 days to one and a half months. All details and results of the clinical trial have to be submitted to the DGCI.

It has come to light in the investigation that by disregarding all these rules, doctors in private hospitals have earned huge amounts of money by conducting clinical trials at the risk of unaware patients’ lives.