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Informist, Thursday, Nov. 14, 2024

 

NEW DELHI – The Supreme Court on Thursday rejected a public interest litigation seeking a mandate from the government for all medical professionals to specify to the patient all possible risks and side effects associated with a drug or a pharmaceutical product being prescribed. The petition filed by Jacob Vadakkanchery, a naturopath and social worker based in Kerala, said that medical professionals should specify the side effects in an additional slip in the regional language along with the prescription. 

 

The Bench of Justice B.R. Gavai and Justice K.V. Viswanathan said general practitioners would not be able to attend more than 10-15 patients if this was followed. The Bench said it was "not practical at all" and for every patient there are different medicines. 

 

Advocate Prashant Bhushan, appearing for the petitioner, said that the World Health Organisation states that a large part of harm is caused to patients because of the adverse effects of medicines. "The only thing that can be done is a local language indicator in pharmacy that read the medicine cover properly," said the court, dismissing the petition. 

 

The petitioner had moved the apex court after the Delhi High Court had dismissed its petition 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 Delhi High Court Bench of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora had said.

 

The petitioner had said it should be mandatory for the doctor prescribing the drug to explain the side effects of the prescribed drug. Only upon being made aware of the side effects can the patient make an informed choice whether to consume the prescribed medicine or not, he added.

 

The petitioner had said 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.  End

 

Reported by Surya Tripathi

Edited by Deepshikha Bhardwaj

 

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