Delhi High Court: In a matter where a writ petition was filed as a Public Interest Litigation (PIL) seeking a direction to the Union of India to mandate all medical professionals practicing in the country to specify all possible risks and side effects associated with a drug, a Division Bench comprising of Manmohan, ACJ* and Manmeet Pritam Singh Arora, J. rejected the same while stating that any directions issued to the legislature would amount to judicial legislation.
Background
The petition was filed by the petitioner to make it mandatory for all medical professionals practicing in the country to specify, to the patient, all kinds of possible risks as well as side effects associated with a drug or a pharmaceutical product that has been prescribed in the form of an additional slip in the regional language.
The petitioner contended that the prescription medications come with side effects and have the potential to do enough harm to the patient. He also submitted that the patient has a right to make an informed choice which is why it should be mandatory for the doctor who prescribes the drug to explain the side effects attached to the consumption of that drug to a patient.
It was also contended by the petitioner that prescribing a drug without specifying the possible side effects of the drug does not amount to valid consent of the patient and hence, the burden to inform the patient must shift from the manufacturer and pharmacist to the medical practitioner since consumers do not give much importance to the insert provided along with the medicine.
The respondent contended that the direction sought by the petitioner was unworkable since medical practitioners were already overworked, and this would hinder rather than facilitate the medical advice given to the patients.
The respondent further submitted that sometimes anticipated side effects associated with Schedule D drugs becomes known and evident in the future after the data accumulates, and if the obligation to inform the patient of the possible side effects is transferred to the medical practitioners, it would expose them to allegations of negligence even though the factum of the side effect becoming a possibility was uncertain at the time of prescription.
Analysis and Decision
The petitioner admitted that there existed legislative safeguards with respect to informing the patient about the possible side effects of the prescribed drugs.
Further, the Court noted that Schedule D(II) of the Drugs and Cosmetics Act, 1945 puts an obligation on the manufacturer or his agent to provide a package insert which shall duly disclose the side effects of the drugs to the consumer. Whereas, Regulation 9.11 of Chapter IV of the Pharmacy Practice Regulations, 2015 imposed a duty upon the registered pharmacist to apprise the patient or his carer about the possible side effects.
The Court also noted that the petitioner does not dispute the sufficiency of the information supplied by the manufacturer through the insert. However, the petitioner contends that if the insert is provided by the doctor along with the prescription, it would be presumed that the patient would be able to make an informed choice with valid consent.
The Court reiterated the observations made in Ashwani Kumar v. Union of India (2020) 13 SCC 585 to state that it is outside the power of judicial review to issue directions to the legislature to enact a law in a particular manner. The Court, while dismissing the PIL, stated that since the legislature had elected to impose this duty on the manufacturer and pharmacist, no ground was found for issuing any direction since it would amount to judicial legislation.
[Jacob Vadakkanchery v. Union of India, 2024 SCC OnLine Del 3686, Decided on 15-05-2024]
Advocates who appeared in this case:
For Petitioner — Advocate Prashant Bhushan, Advocate Anurag Tiwary
For Respondent — CGSC Ravi Prakash, Advocate Astu Khandelwal, Advocate Taha Yasin, Advocate Yasharth Shukla, Advocate Ali Khan, Advocate Ayushman, GP Uzair Ullah Khan, Advocate T. Singhdev, Advocate Aabhaas Sukhramani, Advocate Abhijit Chakravarty, Advocate Bhanu Gulati, Advocate Tanishq Srivastava, Advocate Anum Hussain, Advocate Sourabh Kumar, Advocate Ramanpreet Kaur
