Not Practical! SC Junks Plea Seeking mandate for doctors to Specify Side Effects of prescribed drugs
New Delhi: The Apex Court has dismissed a plea that sought directions to medical professionals to specify to patients all kinds of possible risks and side effects associated with a prescribed drug.
While considering a plea challenging the Delhi High Court's May 15 order rejecting the petition in this regard, the Supreme Court bench comprising Justices BR Gavai and KV Viswanathan observed "It is not practical", PTI has reported.
Accordingly, dismissing the plea, the bench ordered, "We are not inclined to interfere with the impugned judgment and order passed by the High Court. The special leave petition is, accordingly, dismissed."
The plea in the high court had sought directions to the Centre and the National Medical Commission 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.
In the plea, the petitioner had stated that patients have a right to make an informed choice and it should be mandatory for the doctors prescribing the drugs to explain the side effects attached to consuming such medicines to the patient.
The petitioner had told the high court that upon being made aware of the side effects of the drug being prescribed by the doctor, 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 had 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.
Medical Dialogues had earlier reported that back then, the Delhi High Court Division Bench of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora had observed 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.
The HC bench had observed, "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."
"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," the high court had said.
Accordingly, dismissing the plea, the court had said since it was admitted in the public interest litigation (PIL) that there was no vacuum, the directions prayed for could not be issued.
Challenging the order of the High Court, the petitioner approached the Supreme Court bench and Advocate Prashant Bhushan, appearing for petitioner Jacob Vadakkanchery, said the plea raises an important issue as to whether the doctors should be obliged to inform their patients about the possible side effects of medicines they are prescribing.
Supreme Court's observations:
The bench observed a general practitioner may not be able to cater to more than 10 to 15 patients if this is followed and then there may be cases under the Consumer Protection Act.
"It will help in avoiding consumer protection cases of medical negligence," said Bhushan, adding it will be easy for the doctors to have a printed proforma about the possible side effects of the drugs being prescribed.
The bench observed a doctor may be prescribing different medicines to different patients. Bhushan contended that the World Health Organization (WHO) has said about harm to patients due to incorrect medicines being prescribed.
The bench observed that doctors are unhappy with the apex court verdict which brought the medical profession within the ambit of the Consumer Protection Act. "Sorry," the bench said while dismissing the plea.
To view the order, click on the link below:
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