Clinical Research Organizations shifting focus to North India

The United States of America and Europe have long been the largest and most prestigious hub for clinical research. But as North America's population continues to grow, the number of available clinical research subjects has become inadequate. Clinical research organizations are now shifting their focus to North India where there are more than 1 billion people living close to major international and domestic markets with high disposable income levels.

This shift in focus will be beneficial for Indian economies through increased opportunities for clinical trial subjects who may not otherwise be able to afford treatment in a non-clinical trial setting or by costly western doctors without insurance coverage. India also offers numerous benefits for global drug companies with its large population, availability of resources in terms of manpower, hospital beds, and a highly educated workforce.

Early studies showed that while clinical trials in India had the potential to be profitable, they lacked in quality, transportation, and qualified personnel. However, over the past few years, India has been working to correct these problems and increase clinical trials. The government's National Clinical Trial Policy (NCTP) is aimed at increasing potential profitability for research organizations and deal with many of the aforementioned issues.

The NCTP is a set of guidelines and procedures intended to provide a clear frame work for drug companies interested in conducting clinical trials within the country. The NCTP describes the process for granting permission for trials, supervision of the researchers, compensation to be provided to volunteers, and the documentation that is necessary for clinical trial conduct. The result of this policy has been an increase in clinical trials from 1,000 in 2006 to 3,000 in 2007.

Research organizations have also taken steps to increase trials at their own facilities. Some of these steps include updating infrastructure and hiring more qualified staff. Research organizations are now starting to create brand identities within India by focusing on their efficiency and quality. This means that they are now able to provide services that compete with western countries while offering a price point that Indian consumers can afford.

Although clinical trials in India still have a ways to go, they are currently one of the most competitive and rapidly growing niches of the pharmaceutical industry. Many Indian research organizations are forming tie-ups with international firms or expanding their local operations to take advantage of this untapped market.

In India, as per the Clinical Trials (amendment) Rules, 2011 certain guidelines and rules were amended for conducting clinical trials. The guidelines require that patients must provide informed consent regarding the participation in clinical trials and should be free from situations which might compel them to break their confidentiality agreement such as financial liabilities for treatment. Participants shall be treated equitably and fairly at all times, irrespective of the study group to which he/she is assigned.

There are several instances where a clinical trial is conducted without the informed consent of the subject. This particular case was highlighted in the media during August 2014, where a drug trial for an anti-cancer drug was conducted on patients at AIIMS New Delhi without prior informed consent. After this came to light, the government of India set up a committee to look for any possible lapses in the guidelines and actions needed to be taken in future investigations. A report by the committee released on 20 December 2014 revealed that all clinical trials conducted at AIIMS between July 2010 and June 2013 were illegal and unethical and there was gross violation of rules by the doctors involved.

The Supreme Court of India in September 2016, came down heavily on the drug regulator over the delay in making clinical trial data public. The court observed that there was a lack of transparency on the part of drug regulator, Drug Controller General of India (DCGI), in making clinical trial data available to public.

A report by the Union Health Ministry's Registrar General and India's drug regulator, Drug Controller General of India (DCGI), the report stated that clinical trials needed to be made public in order to build trust in clinical trial programmes and in order to encourage best practices. While DCGI argued that clinical trial information was private, the Supreme Court of India found this argument wanting noting that "it is against national interests to keep data of clinical trials secret. It is to promote transparency in drug development and the system for putting such information on public domain. The stake of the patient is substantial and serious."

The Supreme Court based its judgement on the Drugs Control Amendment Act, 2013 which came into force after a report submitted by a seven-member committee in May 2013. The committee was headed by Harsh Mander and had experts from Tata Memorial Hospital, Indian Institutes of Technology and Indian Institute of Management directorate as members. The committee submitted its report to the government in May 2013 and made 11 observations. The committee made recommendations that clinical trials should be equally open to all with patient consent while maintaining privacy concerns. Clinical trials data should be disclosed to public at regular intervals on website, newspapers, radio and television under public demand. The Drug Controller General of India had taken a view that clinical trial data should not be made public as it would compromise patient privacy. The court due to lack of transparency from DCGI ordered the government to take action in this regard.

Government and private hospitals conduct many clinical trials for new drugs, medical devices and diagnostic procedures. There are over 10,000 clinical research trials have been registered by the Indian Council for Medical Research (ICMR), Food and Drug Administration (FDA), National Institute of Health (NIH), National Clinical Trials Centre (NCTC) etc. Every year there are around 25,000; for a variety of reasons, not all of them are listed publically.

In India around 300 clinical trials are conducted every year by more than 100 research organisations. About 80-90% of the trials conducted in India are in routine clinical practice and only a few involve life-threatening conditions such as HIV, cancer and tuberculosis. A research report has been submitted to the Supreme Court, which is likely to be heard early next year. The Supreme Court has ordered that clinical trial data be made public after it was found that clinicians were conducting trials with little or no knowledge of ethical guidelines or applicable laws.

After this came to light, the Government of India (GOI) set up an expert committee to look into the matter and recommend the appropriate action. The committee submitted its report on 20 December 2014 and found that several clinical trials conducted at AIIMS were illegal and unethical.

In 2002, Indian government had enacted Legislative & Statutory changes for Clinical Trials in India. These were two separate pieces of legislation that resulted from a Parliamentary Standing Committee Report in 1999.

Conclusion

The regulation of Clinical Trials in India is highly complex and the data published by WHO on clinical trials is far from adequate. The industry is itself a fraction of the total number of trials that have taken place in India, and the small proportion of trials for which data are listed (39%) may not be representative of all clinical trials conducted.

Research has shown that Clinical Trials in general result in significantly lower incidence rates for adverse events than those seen in routine practice. In addition, both positive and negative results are published providing patients with more comprehensive information about potential side effects as well as potential benefits from clinical research participation.