India - How safe are our clinical trials?

N K Ganguly,
Former Director General,
Indian Council of Medical Research
These trials are not easy ... They need a surveillance infrastructure and a supporting eco-system. Both are developing. In another five years, our clinical trials environment will be very good
In any clinical trial, tests are done on sick patients and on healthy ones and you check for adverse reactions. So, it is just possible the children who died at AIIMS did not die due to the drugs, I cannot say for sure at this moment. The thing I can say though, is that the system of checks is well-designed — if the results show an adverse reaction, it will be brought to the AIIMS Ethics Committee. In PGI Chandigarh, where a drug was being tested, one such adverse reaction occurred and the trials were stopped.
The major reason for why we need to do clinical trials, of course, is that India is now developing new molecules on its own — previously, we did just limited trials since we were copying drugs developed abroad. Right now, new molecules have been developed for diabetes, TB, cancer, and so on. So we have to do all stages of tests, from I to IV. India has also become a very large hub for producing vaccines and this again makes clinical trials essential.
These trials are not easy — most vaccine trials, for instance, can’t be done in a controlled hospital environment but need to be done in field settings. They need a surveillance infrastructure and a supporting eco-system. Both are developing, both will take some time, and in the meanwhile, there will be some unethical practices. But it is a vast country and we are trying to limit this. We’re planning for a new drug regulation authority, there are guidelines for clinical research, a good clinical practices guide, accreditation services for hospitals, Schedule Y (a compendium for clinical trials) has also been updated, and a biotech regulatory authority is in the offing — all told, we’re creating a good regulatory environment for trials.
As for the eco-system, now that around 100 Clinical Research Organisations (CROs) are here, including several top-class global ones, there are training units coming up; masters degrees in clinical research and data management are being offered; Pune University is starting one. The Indian Council of Medical Research has opened five toxicology centres to do the pre-clinical trial part of studies; there are two companies in Mumbai that help find the various pathways through which a drug works; companies are doing pharmacodynamics and pharmacokinetics; several primate centres are coming up; all existing animal facilities have been upgraded… None of this was there earlier and as more such systems develop, the process will get better.
The way the actual testing works is that the sponsor clears every project with the Drug Controller General of India (DCGI) and, as part of the process, has to have a Management Committee, an Ethics Committee and a Data Safety Management Board; there are then various monitoring committees and the DCGI is training people to ensure these guidelines are being followed. The structures are all there and the larger trials, by the Bill and Melinda Gates Foundation for instance, are being done under these rules. But much of this is self-regulatory and there will be lapses. The rules and their implementation are being strengthened and as the support eco-system gets better, the chances of regulatory failure also decline. In another five years, India will have a very strong clinical trials environment in place