The Delhi High Court observed that directing doctors to specify on prescription possible risks and side effects of prescribed drugs would amount to judicial legislation.

The Court stated that the legislature in its wisdom had imposed the duty of informing possible risks and side effects of the drugs on the manufacturer and the pharmacist.

The bench of Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora observed, “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.”

Advocate Prashant Bhushan appeared for the Petitioner.

The present Writ Petition was filed as a Public Interest Litigation seeking a direction to the Union Of India to mandate all medical professionals practising in the country to specify to 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 drug or a pharmaceutical product being prescribed.

The Court noted that Petitioner Jacob Vadakkanachery admitted that there exist legislative safeguards concerning apprising the patient about the possible side effects of the prescribed drugs.

According to the Court Schedule D(II) of the Drugs and Cosmetics Act, 1945 obliges the manufacturer or his agent importing the drug to provide a package insert which shall duly disclose the side effects of the drugs to the consumer. In addition, Regulation 9.11 of Chapter 4 of the Pharmacy Practice Regulations, 2015 imposes a duty on the registered pharmacist to apprise the patient/carer about the possible side effects, etc.

The Court further noted that the Petitioner does not dispute 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.

The Court mentioned the decision of the Supreme Court in Supreme Court in Dr. Ashwani Kumar v. Union of India and Anr. and quoted, “In V.K. Naswa v. Union of India [V.K. Naswa v. Union of India, (2012) 2 SCC 542 : (2012) 1 SCC (Cri) 914] , this Court in clear and categoric terms had observed that we do not issue directions to the legislature directly or indirectly and any such directions if issued would be improper. It is outside the power of judicial review to issue directions to the legislature to enact a law in a particular manner, for the Constitution does not permit the courts to direct and advise the executive in matters of policy. Parliament, as the legislature, exercises this power to enact a law and no outside authority can issue a particular piece of legislation. It is only in exceptional cases where there is a vacuum and non-existing position that the judiciary, in exercise of its constitutional power, steps in and provides a solution till the legislature comes forward to perform its role.”

Accordingly, the Court dismissed the PIL.

Cause Title: Jacob Vadakkanchery v. Union of India (Neutral Citation: 2024:DHC:4066-DB)

Appearance:

Appellant: Adv. Prashant Bhushan Adv. Anurag Tiwary

Respondent: CGSC UOI Ravi Prakash, CGSC, UOI, Adv. Astu Khandelwal, Adv. Taha Yasin, Adv. Yasharth Shukla, Adv. Ali Khan, Adv. Ayushman, Adv. T. Singhdev, Adv. Aabhaas Sukhramani, Adv. Abhijit Chakravarty, Adv. Bhanu Gulati, Adv. Tanishq Srivastava, Adv. Anum Hussain, Adv. Sourabh Kumar and Adv. Ramanpreet Kaur

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Delhi High CourtJustice ManmohanJustice Manmeet Pritam Singh Arora

Tanveer Kaur