Delhi High Court rejects PIL to make doctors explain side-effects of medicines to patients

The Delhi High Court recently dismissed a public interest litigation (PIL) petition seeking directions to to medical professionals to specify in writing all possible risks and side effects associated with a drug or pharmaceutical drugs prescribed to a patient [Jacob Vadakkanchery v Union of India and Anr]..A Division Bench of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora observed that the Drugs and Cosmetics Act, 1945 obliges the manufacturer of the drugs or his agent to provide a package insert disclosing the side effects of the drugs to the consumer and the Pharmacy Practise Regulations, 2015 also imposes a duty on the registered pharmacist to apprise the patient about the possible side effects of a medicine.The Bench said that once the legislature has decided to impose the duty on the manufacturer and the pharmacist, there is no ground for the Court to issue directions as asked for in the PIL because it would amount to judicial legislation.“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,” the Court observed. It, therefore, dismissed the petition."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,” the order said. .The PIL had been filed by one Jacob Vadakkanchery arguing that the medications come with side effects, which have the potential to do much harm and the patient has the right to make an informed choice. Therefore, it should be mandatory for the doctor prescribing the drug to explain to the patient the side effects attached to consuming such a drug.Vadakkanchery stated that prescribing a drug without specifying the possible side effects would not amount to obtaining valid consent of the patient and the emphasis in law to inform the patient must shift from the manufacturer and pharmacist to the medical practitioner..The Bench considered the case and rejected the plea..Advocates Prashant Bhushan and Anurag Tiwary appeared for the petitioner.Union of India was represented by Central Government Standing Counsel Ravi Prakash as well as advocates Astu Khandelwal, Taha Yasin, Yasharth Shukla, Ali Khan, Ayushman, and Uzair Ullah Khan.Advocates T Singhdev, Aabhaas Sukhramani, Abhijit Chakravarty, Bhanu Gulati, Tanishq Srivastava, Anum Hussain, Sourabh Kumar and Ramanpreet Kaur appeared for the National Medical Commission. .[Read Order]