The Supreme Court on Thursday dismissed a Public Interest Litigation (PIL) seeking a directive to medical professionals across India to inform patients about all possible risks and side effects associated with prescribed drugs.
The PIL, filed by Kerala-based naturopath Jacob Vadakkanchery, called for doctors to provide an additional slip, written in the regional language, alongside prescriptions to detail the potential side effects of medications. Vadakkanchery argued that this would help patients make informed decisions about their treatment options.
However, the Bench led by Justice BR Gavai rejected the petition, calling the proposal “not practical.” The Court noted that if doctors were required to provide such detailed information for every prescription, they would be unable to attend to more than 10-15 patients a day. The judges further suggested that a simpler solution could be for pharmacies to provide a local language warning on the medicine’s packaging, advising patients to read the label carefully.
Prashant Bhushan, representing Vadakkanchery, argued that adverse drug reactions contribute significantly to patient harm, citing the World Health Organization’s stance on the issue. Bhushan insisted that doctors should be required to explain the potential side effects of prescribed drugs to enable patients to make informed choices about their medication.
Vadakkanchery also pointed out that under existing laws, the responsibility for disclosing side effects falls on the manufacturer under the Drugs and Cosmetics Act, 1945, and on pharmacists under the Pharmacy Practice Regulations, 2015. However, he contended that these provisions were inadequate and called for medical practitioners to bear the responsibility for informing patients about risks in a language they understand.
This was not the first time the PIL was rejected. In May, the Delhi High Court had also dismissed the petition, noting that the law already assigns the duty of disclosure to manufacturers and pharmacists, and any further intervention would amount to judicial overreach.
With the Supreme Court’s dismissal, the issue of mandatory disclosure of drug side effects by doctors remains unresolved at the national level.
