The Delhi High Court has dismissed a public interest litigation (PIL) that aimed to require all medical professionals in the country to inform patients about all potential risks and side effects associated with any prescribed drug or pharmaceutical product.

A division bench consisting of Acting Chief Justice Manmohan and Justice Manmeet PS Arora has dismissed the plea filed by Jacob Vadakkanchery.

The petitioner argued that prescription medications carry significant side effects that can cause considerable harm. It was contended that patients have the right to make informed decisions, thus it should be obligatory for prescribing doctors to elucidate the potential side effects of the prescribed drugs to patients.

Additionally, it was argued that by informing patients about the potential side effects of prescribed drugs, they would be empowered to make informed decisions regarding their consumption. The court observed that the petitioner acknowledged the presence of legislative safeguards regarding informing patients about possible side effects of 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 also highlighted that the petitioner did not contest the adequacy of the information provided by the manufacturer through the insert accompanying the drug at the time of sale by the registered pharmacist. The court emphasized that since the legislature has chosen to assign the responsibility to the manufacturer and pharmacist, there is no basis for issuing the direction requested in the PIL. Doing so, the court remarked, would essentially constitute judicial overreach.

“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

Title: JACOB VADAKKANCHERY v. UNION OF INDIA AND ANR.