After it was discovered earlier this year that thousands of impoverished people living in rural parts of India were being subjected to what many described as “unethical and flat-out inhumane clinical trials” by Big Pharma companies to determine the safety and effectiveness of new drugs, the country’s Supreme Court ruled last month that there needs to be more protection for the Indian people, who for years have been used as “guinea pigs” by pharmaceutical companies, including those from the United States.
Upset about the number of lives lost from clinical trials, several human rights organizations urged the high court to reform the clinical trial programs in February, and last month, the Supreme Court agreed to help end this arguably inhumane practice by implementing a more strict regulatory framework for drug trials.
One way the court is protecting poor Indian people is by making drug companies liable for any drug trial subject’s injury or death, regardless of whether the death was a result of the study.
According to Indian health officials, about 2,500 drug trial participants died between 2005 and 2012, and of those deaths, only 80 were proven to be linked to the drug tests. A report from Natural Society found that between 2010 and 2012 there were more than 1,500 deaths reported in clinical trials. Officials said 54 were a direct result of participating in a drug trial.
The Indian Supreme Court also ruled that the Indian government needed to justify why it had approved trials for new chemical entities, or NCEs, in the country.
NCEs are drugs that have not been approved yet for marketing or sale, but are being tested in Phase II and Phase III clinical trials, meaning the drug is still being tested for safety and effectiveness, and the manufacturer is determining what side effects the drug has, and if it is any better than products currently available on the market.
Chinu Srinivasan of the non-profit pharmaceutical maker and public health advocacy group Low Cost Standard Therapeutics said India is not a good place for Phase II and Phase III trials for such products because of the inadequacies in the system.
“The ancillary health services are weak. This is not Australia. If a person in a clinical trial in a remote village gets a cardiac arrest, he can’t be immediately flown in to the nearest hospital,” Srinivasan said.
One reason the government has catered to Big Pharma for so long was that these companies, most of which are described as unnamed Western drug makers, paid the government large sums of money to look the other way as they conducted these clinical trials in the poor, rural areas of the country where people have minimal access to proper medical care.
Between 2010 and 2011, the Indian clinical trial industry was valued at $450 million, and grew about 12 percent annually. Many expected that by 2016 the industry would be worth more than $1 billion, but all of that may soon change as a result of the Supreme Court’s decision, especially since according to R K Sanghavi, head of the medical subcommittee of the Indian Drug Manufacturers Association, “the clinical trial industry in India is in shutdown mode.”
Impact of regulatory framework for drug trials
So far the court has suspended at least 157 previously approved clinical trials in addition to the several hundred that Western and Indian drugmakers have cancelled themselves — which include some that have been backed by the U.S. National Institute of Health, which has pulled several clinical trials from the country in recent weeks.
The U.S.-based clinical research organization Quintiles said it has scaled back its operations in India after the Supreme Court’s decision, and GlaxoSmithKline said it is “pausing patient enrollment” into its clinical trials. Several local companies have begun to hold their trials in neighboring nations such as Bangladesh, Malaysia and the Philippines.
Amulya Nidhi, coordinator of the Health Right Forum, one of the organizations that campaigned for tighter regulations and oversight on clinical trials in India, said “Clinical trials of NCE’s are being conducted without following proper protocol, and companies are taking advantage of poor people,” who often times are never even given a consent form to sign.
He applauded the Supreme Court’s decision to intervene in the drug trials and said, “We are concerned about and committed to the interests of people.” Nidhi added that he, and several others who pushed for the increased regulations, couldn’t care less if drug companies lose money as a result of the new regulations, especially if the new laws will protect Indian people from being “used and abused by Big Pharma.”
Many Western journalists agree with Nidhi and have reported that the tighter, better regulations could push “morally bankrupt pharmaceutical companies” from conducting abusive and unethical trials out of the country, and prevent companies from continuing to “treat the Indian people as throw-away laboratory experiments.”
But not everyone agrees that these trials were a human-rights violation.
“If India wants to be the pharmacy of the world, you have to have clinical research,” said Kiran Mazumdar-Shaw, CEO of Biocon, an Indian biopharmaceutical company that works with Bristol-Myers Squibb.
He added that “just because a few companies may not have followed the norms, they have taken this drastic action against all companies,” and said the new rules are a “knee-jerk reaction.”
DG Shah, head of the Indian Pharmaceutical Alliance, agreed and said that while “certain excesses were committed, which did not take care of patient interests…This is a backlash against that, but the pendulum has swung to an extreme.”
Drug companies: Regulations hurt the public…and profits
Since the stricter rules were announced, several pharmaceutical industry executives have argued that the decrease in the number of clinical trials in the country has “cut patient access to new therapies” and threatened the “competitiveness of local drug companies.”
Although Srinivasan supports regulatory changes, she said that many of the changes have favored multinationals, since Ranjit Roy Chaudhury, a leading pharmacologist and head of clinical trials at Apollo Hospital — the largest private sector clinical site in India — was responsible for recommending changes to how the process of approving and conducting clinical trials should be handled.
In its ruling, India’s high court said the government had slipped into a “deep slumber,” and wrote that “It pains us that children of the country are being uses (sic) as guinea pigs by the companies.”
While the court recognized a need for “innovations in research,” they said that those pharmaceutical companies who are “dubious” should be held responsible since “People who lost their lives can’t get their lives back.”
C.M. Gulhati, the editor of India’s Monthly Index of Medical Specialties, agreed with the ruling and said that testing in NCEs “does not help the country.” Instead, Gulhati said the only beneficiaries are multinational drug companies who “cut costs and avoid payment of compensation.”
Since the new regulations were announced last month, only about five clinical trials have been approved in the country.
“The recent negative attention is likely to affect clinical trials in the country,” said V Mohan, a diabetes specialist who has been involved in several trials with diabetes-related drugs, adding that “Unfortunately, this will be a big loss for India.”
Sunella Thatte, president of the Indian Society for Clinical Research, agreed, saying clinical trials are “essential” for improving the nation’s health.
“On one hand, we have a huge burden of diseases common in the third world, such as tuberculosis and malaria. On the other hand, we are seeing a sharp rise in diseases of the developed countries, such as diabetes, hypertension and psychiatric illness.
“Clinical trials are the only hope for seriously ill patients who have tried all treatments without avail. By stopping trials, we’re denying them access to new treatment opportunities,” Thatte said.
Rupam Borgohain, a neurologist and professor at Nizam’s Institute of Medical Sciences, blamed the media for the negative coverage and perception of clinical trials, saying ethical clinical trials and academics have been affected, including himself.
While clinical drug trials in India may slow down in the interim, the country has many local drug makers that were hoping to create several different groundbreaking medicines that would be sold in Western markets, as competition to larger Western-based pharmaceutical companies.