Indian clinical research: A call to self regulate

Hemant Rehani

The clinical research ecosystem in India is changing at a fast pace. In its 15 year history, clinical research in the country has evolved from being a totally naive industry to a maturing one that is moving from just doing drug development to also contributing to drug discovery. Increasingly, global pharmaceutical companies are looking at leveraging the talent and resources in India to focus on innovation rather than myopically viewing India as just another low-cost destination.

The regulatory environment in India has been very active in 2012 and focused on strengthening regulation, increasing controls and governance and setting policies for the future stability of innovative clinical research in the country. We have welcomed the consultative approach taken by the Ministry of Health and Family Welfare on several issues impacting the industry and are hopeful that whatever is developed will be in the best interests of all stakeholders, most importantly patients. By no means is the job of the Government in improving regulation an easy task given mounting media pressure and allegations, public interest litigations and so on.

Allegations have also been levelled that the sea of regulatory changes being planned by the DCGI has been more of a knee jerk reaction to external pressures than part of a long-term strategic plan to develop the industry while protecting the interest of patients and meeting our country’s health objectives. While this is true in some instances, it is also true that much time has been spent by the government in explaining its rationale and decisions to various stakeholders which has hindered quick implementation and progress.

Irrespective of intent and direction of regulation, we cannot ignore the fact that our country is moving towards an exciting era of innovation in drug discovery and development where various stakeholders, be they pharma companies, CROs, investigators or ethics committees, all have a significant and critical role to play. The call to action is self regulation.

In psychological terms, self-regulation refers to the self-altering of one’s own responses or inner states. For example, when otherwise quite different people go to the movie theatre, they tend to behave in similar ways. Most self-regulate themselves.

There are many examples of how self-regulation has helped businesses in changing public perceptions and creating confidence amongst stakeholders. The most prominent example is the advertising industry which has done an excellent job of self-regulation, both in India and overseas. The Advertising Standards Council of India (ASCI) has adopted a Code for Self-Regulation in Advertising. It is a commitment to honest advertising and to fair competition in the market-place. It stands for the protection of the legitimate interests of consumers and all concerned with advertising with an overarching goal of maintaining and enhancing the public’s confidence in advertising. Perhaps the clinical research industry in India would do well to adopt a similar approach even as regulators strengthen policies. Self regulation applies to all stakeholders within the industry, including Ethics Committees (ECs) and investigators. In 2012, we witnessed a lot of discussion over the role of ECs with a call for them to take a more active role in policing investigators. However, the big question remains whether all ECs in India have the resources, both in terms of manpower and time, to do this sort of policing. Investigators have also been at the centre of much controversy and debate in 2012. The investigators-patient relationship is where rubber meets the road in clinical research which is why self-regulation by investigators will be extremely beneficial in curbing incidences that malign the industry and lead to negative reportage.

Self-regulation does not and should not replace government regulation. Rather, it complements an existing framework of law and provides a double layer of protection to consumers. To work well and to win the confidence and assurance of the public, it needs to include stringent sanctions for participant stakeholders who are in breach of code of conduct. Such self regulation would work well for all stakeholders concerned. It would free up time for regulators to work on and develop a more strategic framework for the development of the industry, it would help the industry in some ways to determine and shape its own destiny, it would ensure consensus building and collaboration and finally through transparency and openness, ensure goodwill and buy in from the public at large. While biopharma companies and CROs in India will continue to innovate and reinvent their ways of working to bring safer and more affordable products to the Indian population, there is also a big need in this part of the world for better equipped clinicians willing to change gears to be more active researchers/ investigators and equal partners in the drug discovery and drug development process. India has a strong base of quality researchers. However, that number needs to increase to meet the growing need to bring products to market faster. Given India’s growing economy and increasing healthcare spend (both public and private), the standard of care will continue to improve in 2013. We will also see increasing spends on insurance-based medical care. However, the rising demand for quality healthcare cannot be fulfilled by health insurance alone. There is a need for affordable products that are safe and efficacious. Biosimilars are a solution to meet these realities of our market. The guidelines on similar biologics released by the Government of India have provided the much required fillip to boost the growth of the industry and encourage local biopharma companies who have both, local and global aspirations. In 2012, we saw several companies in Asia announce their forays into biosimilars. In 2013, I believe we will see more R&D in biosimilars, specifically targeted at the Indian market, gaining momentum. As this segment evolves, CROs will develop more mature models to help Indian biopharma companies navigate the complexities of biosimilars development and take their products to market faster. We will see the emergence of models that are customised, competitively priced, globally aligned and more consultative in approach. The biopharma industry needs a robust regulatory environment to foster a culture of innovation and R&D industry in the country. If 2012 was a year of regulatory discussion and debate, 2013 will see the implementation and roll out of several initiatives which will augur well for the industry. The proposed regulatory recommendations will introduce a whole new dynamic to the already complex clinical research scenario in India. We will see the emergence of companies whose focus is on the place where all the real action is that is clinical trial sites. These services could include provision of trained study coordinators, providing technologies that help automate and manage site processes, providing video/audio equipment for informed consent administration, providing site accreditation services and many other sites related services that will help contribute to auditable, systematic, high-quality research at sites. Another emerging opportunity for countries like India to extend their capabilities in clinical research is tapping into neighbouring countries like Sri Lanka and Bangladesh. These countries have similar disease burdens with improving health care delivery systems. Sri Lanka has taken great strides forward in defining a regulatory framework and creating an approved EC network at a national level. Pharma, CROs and investigators from India can play a positive role in helping define and shape the clinical research environment in these countries.

I believe that the dynamics of increased regulation with the growth that we envisage in the domestic sector and biosimilars and opportunities in neighbouring countries will make 2013 an interesting and exciting one for the industry.