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Compassionate drug use: Current status in India.
Yashashri C Shetty1, Smita Brahma2, P S Manjesh1
1Department of Pharmacology and Therapeutics, Seth Gordhandas Sundardas Medical College and King Edward Memorial Hospital, Mumbai, Maharashtra, India.
Perspectives in Clinical Research
|March 11, 2020
Summary
Compassionate use (CU) programs offer life-saving experimental treatments to patients with no other options. India
Area of Science:
- Medical Ethics and Drug Regulation
- Pharmaceutical Policy and Access
Background:
- Compassionate Use (CU) provides access to experimental treatments for patients lacking satisfactory authorized therapies or clinical trial eligibility.
- Global regulatory bodies and pharmaceutical companies have increasingly developed robust CU programs in response to patient needs.
- India lacks a formal "Compassionate Use" designation but has existing provisions within the Drugs and Cosmetics Act 1940 and Rules 1945 for drug importation.
Purpose of the Study:
- To examine the current status and regulatory landscape of compassionate use programs in India.
- To highlight the need for enhanced policies and collaborative efforts to expand access to experimental drugs for critically ill patients in India.
Main Methods:
- Analysis of existing Indian drug regulations (Drugs and Cosmetics Act 1940 and Rules 1945) pertaining to drug importation for medical needs.
- Review of documented cases and drug availability (e.g., bedaquiline, delamanid) for specific conditions like extensively drug-resistant tuberculosis (TB) and multidrug-resistant TB.
- Assessment of the current stage of compassionate use implementation in India.
Main Results:
- Applications for drug importation under existing provisions can be submitted by hospitals, patients, or pharmaceutical companies to the Drug Controller General of India.
- The availability of specific drugs for resistant TB demonstrates the practical application of these provisions.
- Compassionate use is currently in its early stages in India due to a lack of specific governing policies and laws.
Conclusions:
- There is a critical need for the development of formal policies and laws to govern compassionate use in India.
- Collaboration between regulatory bodies and pharmaceutical companies is essential to expand the scope of compassionate use for the benefit of patients.
- Strengthening compassionate use frameworks will improve access to potentially life-saving experimental therapies for underserved patient populations in India.
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