The Delhi High Court has rejected a public interest litigation (PIL) seeking to mandate all medical professionals practicing in the country to specify to a patient, along with the prescription, all kinds of possible risks and side effects associated with a drug or a pharmaceutical product being prescribed. A division bench comprising Acting Chief Justice Manmohan and Justice Manmeet PS Arora dismissed the plea filed by one Jacob Vadakkanchery. It was the petitioner's case that prescription medications come with side effects, which have potential to do much harm. It was submitted 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. It was also contended that upon being made aware of the side effect of the drug being prescribed by the doctor, the patient will be able to make an informed choice, whether to consume it or not. The court noted that the Petitioner admitted that there exists legislative safeguards with respect to 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,” the court noted. The bench further noted that the petitioner did 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 court said that since the legislature in its wisdom has elected to impose the duty on the manufacturer and the pharmacist, there was no ground for issuing a direction as prayed for in the PIL, as it would amount to judicial legislation. “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,” the court said.

Counsel for Petitioner: Mr. Prashant Bhushan and Mr. Anurag Tiwary, Advocates

Counsel for Respondents: Mr. Ravi Prakash, CGSC, UOI with Ms. Astu Khandelwal, Mr. Taha Yasin, Mr. Yasharth Shukla, Mr. Ali Khan and Mr. Ayushman, Advocates; Mr. Uzair Ullah Khan, GP, UOI; Mr. T. Singhdev, Mr. Aabhaas Sukhramani, Mr. Abhijit Chakravarty, Mr. Bhanu Gulati, Mr. Tanishq Srivastava, Mr. Anum Hussain, Mr. Sourabh Kumar and Ms. Ramanpreet Kaur, Advocates for R-2/NMC