The Delhi High Court recently dismissed a public interest litigation (PIL) petition seeking to mandate medical professionals to provide written explanations of all possible risks and side effects associated with prescribed drugs. The petition, filed by Jacob Vadakkanchery, a Kerala-based social worker and naturopath, argued that patients have the right to an informed choice regarding their treatment and should be informed about the side effects of any prescribed medication.
A division bench consisting of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora reviewed the petition. The bench highlighted that the existing legal framework already addresses this issue. Under the Drugs and Cosmetics Act of 1945, drug manufacturers or their agents must include package inserts that disclose the side effects of drugs. Additionally, the Pharmacy Practice Regulations of 2015 require registered pharmacists to inform patients about the possible side effects of medications.
The court stated that since the legislature has placed the duty of informing patients about drug side effects on manufacturers and pharmacists, there was no need for the court to issue further directions. The bench emphasized that issuing such directions would amount to judicial legislation, which is beyond the court’s jurisdiction. The judges observed that the petitioner did not contest the accuracy of the data supplied by pharmacists and manufacturers via package inserts.
Vadakkanchery, represented by advocate Prashant Bhushan, contended that prescribing a drug without specifying the possible side effects compromised the validity of the patient’s consent. Bhushan argued that it should be mandatory for doctors to explain the side effects attached to consuming such drugs, as this would enable patients to make informed choices.
In response, the Center, represented by advocate Ali Khan and standing counsel Ravi Prakash, argued that the plea recognized the existence of adequate legislation that requires medical professionals to warn patients of potential negative effects. They claimed that it would be impossible to assign this duty to physicians since it would increase their already excessive workload and compromise the standard of care that they provide.
The National Medical Commission, represented by advocate T. Singhdev, supported this stance, adding that the request for doctors to provide information in regional languages was impractical. Doctors who work across different states in India may not be familiar with all regional languages, making such an obligation impossible.
The court concluded that there was no legislative gap justifying the issuance of the requested directions. The bench stated, “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.” Consequently, the PIL and accompanying applications were dismissed.
(Input from various sources)
(Rehash/ Susmita Bhandary/MSM)