Supreme Court rejects PIL for mandatory disclosure of drug side effects by doctors

The Supreme Court on Thursday rejected a PIL seeking a direction to all the medical professionals in the country to specify to their patients all possible risks and side effects associated with a drug or a pharmaceutical product being prescribed.

Kerala-based naturopath Jacob Vadakkanchery wanted that all medical professionals should specify the side effects in an additional slip in the regional language along with the prescription.

The Bench led by Justice BR Gavai said if this practice is followed, then the general practitioners would not be able to attend more than 10-15 patients if this was followed. It was "not practical at all" and for every patient there are different medicines, the apex court said.


“The only thing that can be done is a local language indicator in pharmacy that read the medicine cover properly," the judges said, while rejecting the petition.

Counsel Prashant Bhushan on behalf of Vadakkanchery argued that the World Health Organisation states that a large part of harm is caused to patients because of the adverse effects of medicines.

It should be mandatory for the doctor prescribing the drug to explain the side effects of the prescribed drug and only upon being made aware of the side effects the patient can make an informed choice whether to consume the prescribed medicine or not, Bhushan submitted.

The petitioner also told the SC that the existing regime puts the obligation to communicate the potential risks and side effects on the manufacturer under the Drugs and Cosmetics Act, 1945, and on the pharmacists under the Pharmacy Practice Regulations, 2015. However, these stipulations in the law are not sufficient, Vadakkanchery said, adding that the medical practitioner prescribing the drug should be made responsible for providing the information to the patient, in the regional language, about potential risks.

The Delhi High Court had also rejected the PIL in May. "Since the legislature in its wisdom has elected to impose this duty on the manufacturer and the pharmacist (to state about side effects), we do not find any ground for issuing a direction as prayed for in this PIL as it would amount to judicial legislation," the HC had said in its May 15 order.