India at a crossroads

Prashob K P | 10-January-2013

Apurva Shah is the Chairman of the Association of Contract Research Organisations (ACRO). His challenge is to position Contract Research Organisations (CROs) as a top level provider of comprehensive clinical solutions to the bio-pharmaceutical industry. He is helping ACRO promote quality research, uphold ethics, share best practices, promote synergies among members, to deliberate and act upon common concerns, especially with regard to Indian regulations and the industry environment. Founder and Managing Director of Veeda Clinical Research Pvt Ltd, he set up a medical college and two 500-bed hospitals in Central India as a trustee of the Ujjain Charitable Trust Hospital & Research Centre. In an exclusive interview with Future Medicine, Shah explains what CROs are all about

By Prashob K P

First of all, how do contract research organisations (CROs) help the healthcare sector? Is India new to this concept?

CROs help the healthcare sector indirectly in several ways:

* By helping pharmaceutical companies develop new drugs, CROs play a role in bringing new drugs to the market, and by developing generic drugs, they help in reducing the costs of healthcare.

* When we conduct drug trials, we introduce a lot of SOPs (standard operating procedures) and best practices in hospitals and clinics. This helps in raising awareness and improving healthcare delivery in some cases.

* We get sponsors to invest in medical equipment that some of the hospitals might not have, thereby improving the infrastructure in those healthcare institutions.

* By doing screening camps, we help in early diagnosis of diseases.

* CROs provide new drugs to some patients, especially terminally ill patients of cancer, which could help extend or improve their lives. These drugs would otherwise not be available in the market or the patients would not be able to afford them.

What made you shift to clinical research and what are the opportunities in this field?

We got interested in this business because it was a sunrise industry. It offered us an opportunity to make a difference in this industry in India. Being a people- and knowledge-oriented business, we could really take advantage of the bright Indian minds, and by offering them the opportunity to learn new drug research, we intended to differentiate ourselves. At Veeda, we wanted to be the bridge between the East and the West.

This industry offers a very long-term growth opportunity due to the requirement for new drugs for chronic and life-threatening illnesses. India, being an upcoming market for research and medicines, would offer us the opportunity for long-term sustained growth.

What kind of a clinical research environment does India provide, both in terms of policies and technological prowess?

Currently, India is at a crossroads. It can take advantage of the big socio-economic opportunity where it already has made substantial inroads or let this opportunity pass away to other upcoming regions in Asia and elsewhere by not reforming the laws and processes in time.

We have suffered a great bit in the past few years due to the inability of the government to regulate the industry, update the laws, or enforce them strictly. The result is that the good players are being penalised for the wrongdoings of a selected few who use this opportunity to exploit the people/patients and make a quick buck. That’s precisely how the benefits this industry can bring to the country and its people are being stolen.

What are the implications of clinical trials in India and what is the role of ACRO in this field?

ACRO works to raise the awareness of the benefits of this industry to India and also works with the regulators to update the laws so that we can develop India as a global centre for R&D, where ethical and quality research is conducted.

Tell us about the safety and ethical standards one has to follow for clinical research in India.

It’s all about patient safety. That’s the most fundamental part of GCP (good clinical practices) that we all follow globally. It is very critical that we understand the Indian environment and draft laws that can suit our requirements, protect our people, and help us do high quality research. Both the aspects cannot be compromised at all.

Which country has the largest clinical research industry? What keeps them ahead in the game?

The US has the largest market share, but Asia and other new areas are growing very fast. The factors that affect growth are the local drug market, the availability of the trained and educated manpower, and the conducive regulatory environment that allows quality research suitable to the industry requirements.

There are a lot of developed and developing countries who are aggressively pushing for promotion of research. Unlike India, they are doing so because they see the benefits and are ready to create a conducive environment for growth of research in their country.

Give us an idea of the regulations and guidelines being practiced by CROs in India.

The Indian regulators are trying to bring in reforms by introducing the guidelines for compensation, compulsory registration of ethics committees etc. All this is very good. But the process needs to be speeded up, or else, it will be too little, too late!

The government needs to first understand the socio-economic advantages of this industry for us and then create the right environment by drafting the right laws and enforcing them. They need to walk their talk, then only we can develop this industry in India and one day in the not so far future, we can develop medicines for our local illnesses at locally acceptable prices.

What are the key challenges faced by the clinical research industry?

The biggest challenge today is that of the bad image created by the lack of a stable regulatory system. The other issue is the bad image that has been created by the media due to the wrongdoings by some select few players. Because of them, the whole industry is seen in bad light. The fact is that a lot of good quality and ethical research is being done in India. Though it has been going on for a long time, it has never been highlighted. We hope that the government realises that we are losing a big opportunity.

Can you cite a few examples of healthcare solutions that have made it to the mainstream from the clinical research labs?

All the new drugs that we consume have gone through clinical research and so have all the new devices that are used to treat illnesses. Without a thorough clinical research process, we cannot be sure of taking medicines. Thousands of lives are saved or are given a better quality of life due to their participation in trials. We all owe our lives to the tens of thousands who have helped us by participating as subjects in trials in the past.

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