The Delhi High Court has dismissed a petition seeking that medical professionals be mandated to specify to a patient all kinds of possible risks and side effects associated with a drug being prescribed.
The high court noted that legislative safeguards are already there to apprise patients about the possible side effects of the prescribed drugs.
A bench of Acting Chief Justice Manmohan and Justice Manmeet PS Arora said since it is admitted in the public interest litigation (PIL) that there is no vacuum, the directions prayed for cannot be issued and the petition is dismissed.
The high court was hearing a PIL by Jacob Vadakanchery seeking a direction to the Centre and National Medical Commission (NMC) 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 high court noted that the petitioner has admitted there exist legislative safeguards with respect to apprising the patient about the possible side effects of the prescribed drugs.
Schedule D(II) of the Drugs and Cosmetics Act 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 Regulations 2015 imposes a duty on the registered pharmacist to apprise the patient about the possible side effects.
"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/ carer would be able to make an informed choice with valid consent," the court order said.
The bench said, "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, appearing for the petitioner, submitted that prescription medications come with side effects, which have the potential to do much harm. He said the patient has a right to make an informed choice and therefore, it should be mandatory for the doctor to explain the side effects attached to consuming such a drug to the patient.
He said on being made aware of the side effects of the drug prescribed by the doctor, the patient will be able to make an informed choice, whether to consume it or not.
Advocate T Singhdev, representing the NMC, said the direction sought by the petitioner that the information be handed over in regional languages is unworkable.
He said doctors work on an all-India basis and are posted in different states and they may not be conversant with the regional language and therefore, unable to comply with the directions sought.
He contended 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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