by Sara John*
I felt awful after watching the Malayalam movie ‘Appothecary’, which shows a doctor’s dilemma, as he is forced to test drugs on his patients at the behest of a pharmaceutical company. The film produced by two doctors carefully plots the nuances of medical ethics, sticking to the message of supremacy of money over ethics and values, and how patients are treated as guinea pigs by conducting clinical trials on them without their consent or knowledge. It made me think if such things really happened in our hospitals. So I found it interesting to look into the regulations of the clinical trial industry in India, and chose it as the topic for my Saturday presentation at CPPR.
As I read a few articles on clinical trials, I realised that a set of people perceived it as an economic opportunity that needs to be tapped well, while there were others, who expressed their concern over the malpractices done under the shroud of clinical trials. The harmonisation of patent laws in the post WTO period and the amendment of Schedule Y of Drugs and Cosmetics Rules spearheaded the growth of the clinical trial industry in India. Globalisation and relaxation of rules smacked of the possibility of Indian patients being treated as guinea pigs, while considering the ethical principles of conducting clinical trials in the host country by the sponsor country.
The clinical trial industry in India progressed, as the country promoted itself as an ideal location for clinical trials, considering the diversity of diseases, huge population and low cost associated with conducting trials. It gave rise to many cases questioning the credibility of the trials and the logic of approving certain clinical trials, and pointing out the failure to give due compensation to the relatives of the victims of clinical trials. Is it fair that pharmaceutical companies go scot-free, even if they fail to give compensation to the victims? A plethora of such instances and questions raised by various NGOs led to the adoption of stringent regulatory measures and involvement of the Supreme Court, which made the conduct of clinical trials in India a cumbersome and time-consuming process, resulting in many foreign companies withdrawing their studies from India.
The question to be raised is whether stringent regulations are the right approach to solving the problem. The real problem is laxity on the part of authorities to enforce the guidelines. The fact is that we need clinical trials, considering the rising healthcare requirements of human beings. By imposing stringent regulations, we are depriving ourselves of advanced medicines and services. Though many ethical issues are involved, we cannot deter the conduct of clinical trials, as we need advanced medicines to survive.
Intending to speed up the availability of new drugs, the government has come up with new proposals, which are expected to reduce the time taken to introduce new drugs to 45 days. This, in turn, will improve ease of doing business for drug makers in the country. It is indeed a welcome step but again the question remains – what is the main intention or priority for conducting clinical trials for the various stakeholders? Is it health or human wellbeing or economic expediency? I do not have the correct answer, as everyone would have his/her reasons to justify the choice. Besides, it is difficult to define right and wrong. However, every choice has its consequences and the way of conducting clinical trials and the ethical part of it are largely dependent on the scale of priority given to the two intended benefits of clinical trials.
Sara John is Project Associate at Centre for Public Policy Research. Views expressed by the author is personal and does not reflect that of CPPR.