Dr KK Aggarwal

Padma Shri Awardee

Off-label use of drugs is a common practice all over the world. Off label use means that the particular drug is used for an indication that is not otherwise approved by the regulatory authority, the Drug Controller General of India (DCGI) in our country, and is not included in the package insert. The package insert or label carries instructions about indications, contraindications and dosing and other instructions. This information is approved by the DCGI for every drug sold in India.

In the Anuradha Saha case of medical negligence, the dose of the injection depomedrol prescribed (80 mg twice daily) was much higher than the maximum recommended dose as recommended by the manufacturer. Anything, which is not as recommended by the manufacturers or is outside DCGI’s recommendations is off-label use and can be called a trial.

Informed and documented consent must be taken from the patient and/or relatives before any off-label use of a drug. And, this ‘documented’ consent must be preserved.

The NICE guidelines on the diagnosis and management of constipation in children and young people also emphasize that PEG is not approved for use to treat chronic constipation in children younger than two years. And, before using it in this age group, informed consent should be taken, which must be documented.

Knowledge is our best defense. Forearmed is better prepared…Unfortunately, these important subjects of CDSCO and DCGI are not taught in Pharmacology.

It is time that we begin to read about the DCGI drug approval procedure in the country. Because if we do not, then patients might start challenging us.