It is Manufacturers', Pharmacists' Duty to Inform Drug Side Effects to patients, not Doctors: Delhi HC
New Delhi: The plea seeking directions upon the doctors to specify all the possible risks and side effects associated with a drug or pharmaceutical drugs prescribed to a patient has recently been dismissed by the Delhi High Court.
The HC Division Bench of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora dismissed the plea after observing that as per the Drugs and Cosmetics Act, 1945, the drug manufacturer and his agent are required to provide a package insert disclosing the side effects of the drugs to the consumer.
Further, the Court noted that the registered pharmacist must inform the patient about the possible side effects of a medicine under the Pharmacy Practise Regulations, 2015.
Taking note of these factors, the HC bench opined that since the law has imposed the duty on the manufacturer and the pharmacist, the Court does not have a ground for issuing directions as asked in the PIL because it would amount to judicial legislation.
One Jacob Vadakanchery filed the petition as a Public Interest Litigation (PIL) seeking a direction to the authorities including the Union Government to mandate all professionals practising in the country to specify to a patient, in the form of additional slip in the regional language, along with the prescription, kinds of possible risks and side effects associated with a drug or a pharmaceutical product being prescribed.
The petitioner's counsel argued that the prescription medications come with side effects having the potential to do much harm. He argued that 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.
He stated that by being made aware of the possible side effects of the prescribed medicines, the patient would be able to make an informed choice, whether to consume it or not. Referring to the existing laws, the petitioner's counsel argued that the obligation to communicate the potential risks and side effects on the manufacturers and the pharmacists are not sufficient. He argued that it was 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.
Further, he stated that prescribing a drug without specifying the possible side effects does not amount to obtaining valid consent from the patient. He stated that the emphasis in law to inform the patient must shift from the manufacturer and the pharmacist to the medical practitioner. In this regard, he argued that patients do not tend to take serious note of the insert when it is provided by the manufacturer and/or the pharmacist.
On the other hand, in response to the PIL, the government counsel submitted that the direction sought by the petitioner is unworkable considering how overworked medical practitioners are and would hinder rather than facilitate medical advice to the patients. He submitted 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.
While considering the matter, the HC bench noted that the responsibility of informing about the drug side effects is upon the manufacturers and the pharmacists under Schedule D(II) of the Act of 1945 and Regulation 9.11 of Chapter 4 of the Regulations 2015.
"The Petitioner admits that there exist legislative safeguards with respect to the apprising the patient about the possible side effects of the prescribed drugs. Schedule D(II) of the Act of 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 Regulations 2015 imposes a duty on the registered pharmacist to apprise the patient/carer about the possible side effects, etc." noted the Court.
Therefore, the Court opined,
"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."
"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," it further observed.
The bench observed that since the legislature in its wisdom has elected to impose this duty on the manufacturer and the pharmacist, there is no ground for issuing a direction as prayed for in this PIL as it would amount to judicial legislation.
With this observation, the bench dismissed the PIL and noted, "However, since, in the present PIL it is admitted that there is no vacuum, the directions prayed for cannot be issued. Accordingly, the present PIL along with applications is dismissed."
To view the order, click on the link below:
https://medicaldialogues.in/pdf_upload/delhi-hc-order-238773.pdf
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