In the plea, the petitioner stated that upon being made aware of the side effects of the drug being prescribed by the doctor, the patient will be able to make an informed choice about whether to consume it or not.
New Delhi: The Delhi High Court on Monday dismissed a Public Interest Litigation (PIL) seeking direction from the Centre 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 petitioner stated that upon being made aware of the side effects of the drug being prescribed by the doctor, the patient will be able to make an informed choice about whether to consume it or not.
The petitioner, Jacob Vadakkanchery, through Advocates Prashant Bhushan and Anurag Tiwary, stated that prescription medications come with side effects that have the potential to do much harm. The patient has a right to make an informed choice and therefore, it should be mandatory for the doctor prescribing the drug to explain the side effects attached to consuming such a drug to the patient. The plea stated that in the existing regime, the obligation to communicate the potential risks and side effects exists 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’).
It also stated that, however, these stipulations in the law are not sufficient. It is the medical practitioner prescribing the drug who should be made responsible for handing out information about the potential risk to the patient in the regional language. Advocate Prashant Bhushan for the petitioner stated that prescribing a drug without specifying the possible side effects does not amount to obtaining valid consent of the patient. He stated that the emphasis in law on informing the patient must shift from the manufacturer and pharmacist to the medical practitioner.
The medical practitioner should be the individual handing out the insert provided by manufacturers to the patient while prescribing the drug, as it would highlight the significance of the declarations made in the insert to the patient. He stated that patients do not tend to take serious note of the insert when it is provided by the manufacturer and/or the pharmacist. The bench of Justice Manmohan and Justice Manmeet Pritam Singh Arora passed an order on May 15, and 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.
Court further said that the Petitioner does not dispute with respect to 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 Petitioner however, contends that if the same insert is provided by the doctor along with the prescription, it can be presumed that the patient/career would be able to make an informed choice with valid consent.
Appearing for Centre, counsel stated that the petition acknowledges that there exists sufficient legislation to ensure that the patient is aware of the potential risks and possible side effects of the drugs. He stated that the existing provisions in the Act of 1945 and the Regulations of 2015 ensure that the risk is duly communicated to the patient. He stated that the direction sought by the writ Petitioner is unworkable considering how overworked medical practitioners are and would hinder rather than facilitate medical advice to the patients.
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