A PIL sought a direction mandating doctors to hand patients a regional-language slip detailing drug side effects with each prescription. The Court held the legislature has already imposed disclosure duties on manufacturers and pharmacists, and issuing further directions would amount to judicial legislation. The petition was dismissed.
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JACOB VADAKKANCHERY ..... Petitioner Through: Mr. Prashant Bhushan and Mr. Anurag Tiwary, Advocates
versus
UNION OF INDIA AND ANR. ..... Respondent Through: Mr. Ravi Prakash, CGSC, UOI with Ms. Astu Khandelwal, Mr. Taha Yasin, Mr. Yasharth Shukla, Mr. Ali Khan and Mr. Ayushman, Advocates Mr. Uzair Ullah Khan, GP, UOI Mr. T. Singhdev, Mr. Aabhaas Sukhramani, Mr. Abhijit Chakravarty, Mr. Bhanu Gulati, Mr. Tanishq Srivastava, Mr. Anum Hussain, Mr. Sourabh Kumar and Ms. Ramanpreet Kaur, Advocates for R-2/NMC % Date of Decision: 15th May, 2024
CORAM:
HON'BLE THE ACTING CHIEF JUSTICE HON'BLE MS. JUSTICE MANMEET PRITAM SINGH ARORA
JUDGMENT
MANMOHAN, ACJ: (ORAL)
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W.P.(C) 5120/2024
kinds of possible risks and side effects associated with a drug or a pharmaceutical product being prescribed.
2.1. He states that in the existing regime, the obligation to communicate the potential risks and side effects exist on the manufacturer under Clause 6.2 of Schedule D(II) of the Drugs and Cosmetics Act, 1945 (‘Act of 1945’) and on the pharmacists under Regulation 9.11 of Chapter 4 of the Pharmacy Practice Regulations, 2015 (‘Regulations of 2015’). He states that however, these stipulations in the law are not sufficient. He states that it is the medical practitioner prescribing the drug, who should be made responsible for handing out the information about the potential risk to the patient in the regional language.
2.2. He states that prescribing a drug without specifying the possible side effects does not amount to obtaining valid consent of the patient. He states that the emphasis in law to inform the patient must shift from the manufacturer and pharmacist to the medical practitioner.
2.3. He concludes by stating that the medical practitioner should be the individual handing out the insert provided by manufacturers to the patient
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while prescribing the drug as it would highlight the significance of the declarations made in the insert to the patient. He states that patients do not tend to take serious note of the insert when it is provided by the manufacturer and/or the pharmacist.
1 (2005) 6 SCC 1 (paras 24 and 25)
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prescribed and sometimes the anticipated side effects become known and evident in future after the data accumulates. He states that if the obligation to apprise the patient of the possible side effects is transferred to the medical practitioner, it will expose the doctor to allegations of negligence in future even though the factum of the side effect becoming a possibility was uncertain at the time of prescription.
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legislation. In this regard, it would be apposite to refer to the observations of the Supreme Court in Dr. Ashwani Kumar v. Union of India and Anr.2 , which reads as under:
“31. 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.”
ACTING CHIEF JUSTICE
MANMEET PRITAM SINGH ARORA, J
MAY 15, 2024/ hp/aa
2 (2020) 13 SCC 585
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1 issue framed by the court
Whether courts can direct that medical practitioners must disclose drug side effects to patients in regional language along with prescriptions.
Colour shows how this judgement treated each authority
Dr. Ashwani Kumar v. Union of India and Anr.Relied on¶8
(2020) 13 SCC 585 · Who else cites this
2 provisions across 2 enactments
Jacob Vadakkanchery
Union of India
National Medical Commission
Manmohan
Manmeet Pritam Singh Arora
As recorded by the court registry
A petition under Article 226 of the Constitution asking a High Court to issue a writ against the State or a public authority in a civil matter.
Judgements on the same questions, provisions and authorities, from every court
