“The only thing that can be done is a local language indicator in the pharmacy that reads the medicine cover properly."
-Supreme Court
In a landmark decision, the Supreme Court denied an application that sought to require physicians to list every potential adverse effect of the medications they recommend to their patients.
The plea, filed by petitioner Jacob Vadakkanchery, argued that patients have the right to be fully informed about the risks associated with their medications to make informed choices.
Background of Case-
The plea filed by petitioner Kerala-based naturopath Jacob Vadakkanchery challenged a previous decision by the Delhi High Court, which had rejected the petition on May 15, 2024. The plea in the high court had sought directions to the Centre and the National Medical Commission to mandate all physicians practicing in the country to inform a patient in the form of an additional slip in the regional language along with the prescription, all kinds of possible risks and side effects associated with a pharmaceutical product being prescribed.
Advocate Prashant Bhushan, appearing for petitioner Jacob Vadakkanchery, said the plea raises an important issue as to whether the doctors should be compelled to inform their patients about the possible side effects of medicines they are prescribing.
| “It will help in avoiding consumer protection cases of medical negligence. It will be easy for the doctors to have a printed proforma about the possible side effects of the drugs being prescribed.” – Advocate Prashant Bhushan |
| “Patients have a right to make an informed choice and it should be mandatory for the doctors prescribing the drugs to explain the side effects attached to consuming such medicines to the patient.” -Petitioner |
| “Upon being made aware of the side effect of the drug being prescribed by the doctor, the patient will be able to make an informed choice whether to consume it or not.” –Petitioner (in High Court) |
High Court Statements –
The Delhi High Court had also rejected the PIL in May.
| “The petitioner does not dispute with respect to the sufficiency of the information supplied by the manufacturer through the insert provided with the drug at the time of sale by the registered pharmacist.” “Since the legislature in its wisdom has elected to impose this duty on the manufacturer and the pharmacist, we do not find any ground for issuing a direction as prayed for in this PIL as it would amount to judicial legislation.” –The High Court |
Supreme Court Statements–
A bench comprising Justices B.R. Gavai and K.V. Viswanathan heard the case. The said that it is impractical.
| “The general practitioners would not be able to attend more than 10-15 patients if this was followed.” -B.R. Gavai |
Conclusion
The responsibility of informing patients about drug side effects primarily lies with pharmaceutical companies, which already include this information in the packaging. The ruling enhance the balance between patient rights and practical considerations in medical set-ups.
The Medical Bulletin
Leave a Reply