Delhi HC rejects plea mandating doctors to explain risks of prescribed drugs

Countering the claims, the Centre stated that the plea acknowledged the existence of sufficient legislation to make the patients aware of the potential side effects

The Delhi high court has dismissed a plea seeking to mandate doctors to explain all the possible risks and side effects of a prescribed drug to a patient saying that the legislature has elected to impose this duty on the manufacturer and the pharmacist.

The court said the directions could not be issued as the plea acknowledged the existence of legislation. (Representative file photo)

“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,” a bench of acting chief justice Manmohan and justice Manmeet PS Arora said in the May 15 order, released on Saturday.

The court was addressing a plea filed by one Jacob Vadakanchery, claiming to be a naturopath and social worker, which stated that prescribing a drug without specifying the possible side effects did not amount to obtaining valid consent of the patient.

The plea filed through advocate Prashant Bhushan claimed that though the Drugs and Cosmetic Act obligated manufacturers to communicate the potential risks and side effects to the consumers, there was a need to shift the obligation from the manufacturer and pharmacist to doctors.

Countering the claims, the Centre represented by standing counsel Ravi Prakash and advocate Ali Khan stated that the plea acknowledged the existence of sufficient legislation to make the patients aware of the potential side effects.

The counsels further asserted that the relief sought was “unworkable” as the doctors were already overburdened and further obligating them to communicate the risks would hinder rather than facilitate medical advice to the patients.

While, the National Medical Commission, represented by advocate T Singhdev submitted that the prayer for directing the doctors to hand over the information in all regional languages was unworkable as doctors work on all India basis and there was a possibility of them not being conversant with all the languages.

The counsel further added that imposing such an obligation on the doctors would expose the doctors to allegations of negligence in future.

Consequently, the court rejected the petition observing that the directions could not be issued as the plea acknowledged the existence of legislation.

“However, since in the present PIL it is admitted that there is no vacuum, the directions prayed for cannot be issued,” the court noted.