Investigational and off-label uses of drugs: Remedy at hand
Any prescription of a medicinal product outside approved indications and not respecting its contraindications, warnings, cautions and precautions is considered as its off-label application. However, a manufacturer has no liability on account of any serious or adverse effects, in case of the off-label usage of the drugs, and the cost of treatment may not be reimbursed. Many a times even doctors prescribe off-label uses of drugs due to a variety of reasons. These may include the non-availability of a particular drug for a disease or a condition that compels one to intake an off-labelled medicine such as application of an injectable anti-bacterial to a wound or surgical-site or taking a pill for headache in case of body pain. To know more, read on…
About the Author:
Dr A K Batham is executive director, ACEAS Clinical Research, Ahmedabad. He has worked as a medical director for large Indian pharmaceutical companies and possesses an extensive experience of more than 27 years in clinical research, regulatory affairs, and medico-marketing in the pharmaceuticals industry. He is also engaged in providing training and consultancy services in clinical research and medico-marketing to pharmaceutical companies and CROs. Dr Batham can be contacted on email: aceas@rediffmail.com
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