The clinical trials industry in India has exploded over the last few years as drug companies have realised the potential for outsourcing trials to this region for fast subject recruitment and major cost savings.
Meanwhile, Indian regulatory authorities are not yet experienced enough and do not have the infrastructure set up to adequately cope with this clinical trial explosion and monitor the situation as tightly as possible.
"The regulatory process in India still has many holes in it and these will take a while to stamp out," Dr Faiz Kermani of Chiltern International, the largest independent employee-owned contract research organisation (CRO) in the world, recently told Outsourcing-Pharma.com.
In this potential legal and ethical minefield, "Indian regulatory authorities are still trying to find their feet."
According to Dr Vasudeo Ginde, president and managing director of Indian-based CRO iGATE clinical research, India's regulatory authorities will be "on the right track within the next 18 months."
"During this time they need to build up more staff, become more electronically savy, and work together with other global regulatory authorities such as the US Food and Drug Administration (FDA) to put the best procedures in place," said Dr Ginde.
"In the meantime, those in the industry need to apply a lot of self-regulation as the cost of making a mistake or having to repeat a trial is very high."
Dr Ginde gave Outsourcing-Pharma his tips on how pharma firms and CROs operating in India can do their best to ensure that clinical trials in the region are carried out ethically and according to global regulatory standards.
"First of all it is crucial that all investigators and clinical research associates (CRAs) are well trained in informed consent, including how to accurately document this informed consent, as well as any questions and answers asked, in the hospital records," said Dr Ginde.
"Secondly, because we know that realistically principal investigators don't have enough time to spend with each patient explaining the clinical trial process to them and gaining satisfactory informed consent, another physician should be nominated as a co-investigator to do this."
Dr Ginde also gave some advice on how to look for signs of patient consent fraud.
"If all or a most of the patients sign the consent form on the same day they received it, without taking time to think about it, then this is suspicious," said Dr Ginde.
"Similarly, investigators should keep a list of all the patients who refused to give consent to participate in the trial and their reasons why - if everybody who is asked to participate in the trial agrees to do so, this is also suspicious."
Finally, Dr Ginde stressed that all CROs should make sure their sponsor provides adequate insurance for the patients, so that in the unlikely event that a patient experiences an adverse reaction while on the trial, they are covered for medical treatment.