Can the drugs that are in the final stages of clinical trial in India, and available with chemists, be administered? Is patient’s consent is required before administering such drugs? Moreover, does international guidelines on prescribing such drugs hold any weight in India? An important clarification made in this case…
Irrefutable Facts
A 72-year-old patient, reeling from several health ailments, suffered a paralytic stroke and was admitted to the hospital in an emergency. She was managed conservatively.
During treatment, the patient suffered sudden left hemiparesis, possibly due to Transient Ischemic Attack (TIA). She was administered a low dosage of IV Ozagrel, considering her age, and was put on a ventilator.
After 5 days, the patient showed considerable improvement and was weaned off the ventilator. The attendants sought DAMA and shifted her to another hospital where she died.
Her family sued the hospital. It was alleged that the treating doctors were aware about patient’s old age and comorbidities; yet she was administered drugs which were under clinical trial and were continued even when she was put on a ventilator.
It was further alleged that the said drugs were administered without prior approval of the licensing authority and without obtaining an informed consent.
Hospital’s Plea
It was stated that the patient was suffering from several health ailments like hypertension, Diabetes Mellitus, and severe obesity. Therefore, she was prone to cerebral stroke and MI.
It was pointed out that the drugs administered were not trial drugs at that point in time. They were available with any chemist and thus, had already completed fourth phase of the trial.
Court’s Observations
The court found that the said drugs were already available in the market with the chemist, and their trial was in the fourth phase. The court, therefore, held that patient’s consent was not required, as alleged. The court observed that Ozagrel is an extensively used drug for ischemic stroke approved by DGCI, and hence there was no malpractice or violation of rules by the treating doctors as alleged.
The court perused US guidelines produced by the patient’s son and observed that “these stroke guidelines are approved in the USA, therefore, can not necessarily be directly adopted into clinical practice in India.” Hence, the case against hospital was dismissed.
Prevention Is Better Than Cure
- Drugs / medicines readily available over the counter with the pharmacist / chemist can be prescribed without any restrictions that are imposed on trial drugs. Patient’s informed consent is not required before administering such medications.
- Guidelines / protocols of one country may or may not be applicable in other countries. But as the subject is modern medicine and evidence-based, these guidelines certainly have a persuasive value and can be referred to in suitable cases. Similarly, only a few international guidelines are universally acceptable. But they have more weightage compared to the national guidelines of other countries, especially the ones of credible organizations. Doctors must be aware and updated and must follow them.
Source : Deepak Sahay & Ors. v/s Abdur Razzaque Ansari Memorial Weavers Hospital (Apollo Hospitals Group) & O
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