The discovery of unauthorized clinical trials being conducted by some doctors of Goa Medical College might be just the tip of an iceberg. It is yet to be known how many unauthorized clinical trials these doctors have conducted for pharmaceutical companies and for how long. It is also not known whether other doctors at GMC too were engaged in such unapproved clinical trials. There is nothing wrong in conducting clinical trials. That is the way the efficacy of a new drug can be tested. However, as the discovery of unauthorized trials at GMC showed, clinical trials were not being carried out in ethical manner in all cases. Pharmaceutical companies establish direct contact with doctors to conduct trials, as they did in the GMC case. Two years ago, the central regulator Drug Controller General of India (DCGI) placed some restrictions on the trials. For instance, any clinical trial had to be approved by a government committee; and pharmaceutical companies had to have a videotaped consent of each patient who was being used as test subject. The regulator also laid down a condition that at least half of the clinical trials had to be conducted in government-run hospitals.
None of these regulations were followed in the clinical trials the doctors at GMC were conducting. The state health department or the GMC Dean was not at all brought into the picture by the pharmaceutical companies or the doctors. The doctors carried out the trials in association with their trusted and conspiring assistants on patients exploiting their gullibility, vulnerability and poor financial situation. No videotaped consent of the patient was taken. It is believed that some patients developed complications after the administration of the test drug. Although only an in-depth inquiry can ascertain whether the death of any patient was caused as a result, the very fact that the clinical trials were being done “privately” in a public institution without any regulatory control suggests a horrifying story. It must be noted that the central regulator had imposed new restrictions after receiving several reports of patients being fooled into and hurt by some trials. But as the GMC case shows, the pharmaceutical companies and greedy doctors had found a way to bypass the restrictions.
The Indian pharmaceutical research market is expected to reach $1 billion in 2016, from $485 million in 2012. The reason is India is one of the cheapest countries for conducting clinical trials. One of the reasons why unauthorised clinical trials like that by some GMC doctors were being carried out was the increase in cost of trial owing to new restrictions imposed by the central regulator. Pharmaceutical companies said they have to expose themselves to huge costs and litigation under the new rules which are unclear. The new rules state that patients be given free treatment by the drug company for “as long as required” without clarifying whether they mean for the life of a patient or the treatment of an ailment. The companies said before the new restrictions were imposed, government approval for clinical trials used to take only a few months. Now it can take longer than nine months.
But does that mean that pharmaceutical companies should find a short cut by making unofficial arrangements with individual doctors? The GMC doctors were accused of claiming to have obtained permission from the GMC’s ethics committee, which had no role in granting administrative and financial approvals. The regulations required doctors to conduct clinical trials only after the government had granted the sanction for it. The doctors were also required to sign a memorandum of understanding with the government for trials. As far as the costs of the clinical trials are concerned, the financial approval of it had to come from the government. Doctors were required to seek financial sanctions from the government and not directly receive any payments from the domestic or foreign pharmaceutical companies. The GMC administration has found that no money paid by the companies for the trials was deposited in government treasury.
The state government must order a judicial inquiry into the allegations against some GMC doctors. Official inquiries might be influenced by various factors. The charges are very serious. They concern human life, human rights and human dignity. Patients, no matter what economic class or age group they might belong to, are alleged to have been used as test subjects without informed consent and any sort of transparency or any concern for the risks the drug trial might pose to their health and life. The government must bring clarity and transparency in the clinical trials and ensure that patients are not exploited.