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The clinical development process of a new drug is like running a marathon — long and demanding. If the start is delayed, you cannot catch up.
In recent years, the country’s health profile has changed significantly. We now have a mix of age-old diseases — communicable diseases — and old-age conditions — non-communicable diseases (NCD). The complexities of health issues are substantial with an equal presence of communicable and non-communicable diseases.
The available therapies are not adequate to manage this burden. We do not have effective therapies to prevent or delay complications of common conditions such as hypertension and diabetes, or reduce mortality of heart diseases and cancers, or manage new infections such as resistant TB and dengue. Hence, there is a compelling need to invest resources in developing new drugs.
Scientific method
Clinical trials form the backbone of new drug development as they are the only scientific method to evaluate and ensure efficacy and safety, and to estimate the benefits and risks of new therapies for patients. Of course, clinical trials must be conducted in compliance with regulations.
Since early 2013, the Ministry of Health has made significant regulatory changes to ensure a stricter conduct of clinical trials. All clinical trials of new drugs are reviewed by the office of the Drugs Controller General of India, New Drug Advisory Committees, the Technical Committee and the Apex Committee before approval. Approval is subject to a sponsor giving an undertaking that it will market the drug in India. Moreover, clinical trials can only be carried out at institutions with registered ethics committees.
Compensation rules provide important safeguards for protection of the rights, safety and well-being of clinical trial participants. The DCGI’s office has inspected several clinical trial sites to monitor compliance to regulations. Current Indian regulations are therefore more stringent compared to US regulations. Despite this, there is a clamour for halting clinical trials of new drugs. Such a retrograde step would have far-reaching consequences on India’s potential for developing new drugs and impact patients.
Crucial development
New drugs are developed, not just by multinational companies, but also by India’s leading research-based pharma companies, government research institutes, academia and universities. It takes over 10-12 years to develop a new drug before it can be marketed.
Clinical development — the most critical process in new drug development — takes around 5-6 years. If trials of new drugs are stopped, how will our country manage its rising disease burden? Should patients be denied the right to better and more effective treatment?
If clinical trials of new drugs are stopped, there will be stagnation in the nascent growing discipline of clinical research.
Let’s hope sane counsel prevails and clinical trials survive the current trials and tribulations.
(The author is council member, Indian Society for Clinical Research.)
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