Delhi High Court Orders DCGI Intervention On Plea Concerning Approval Of Weight Loss Drugs, Directs Stakeholders Consultation

The Delhi High Court on Wednesday ordered intervention of the Drug Controller General of India (DCGI) on a plea filed concerning the issue of approval of drug combinations sold in the market for weight loss treatment.

A division bench comprising Chief Justice DK Upadhyaya and Justice Tushar Rao Gedela directed the DCGI to consult experts and stakeholders, including the manufacturers of the drugs, on the issue.

The Court disposed of a public interest litigation filed by one Jitendra Chouksey, who contended that the licenses for use and sale of the drugs in question have been issued which are not based on adequate data.

It was his case that the same have been issued without conducting any specific trials and studies and without noting the serious adverse health effects of the drugs.

Chouksey's counsel submitted that under the Drugs and Cosmetics Act, it is the DCGI which is the competent and statutory authority entrusted with taking appropriate measures to be taken for ensuring safe use of drugs.

It was submitted that representations were made on April 18 to the Union of India as well as DCGI on the issue.

The Bench noted that the concerns raised in the plea have to be first looked into and addressed by the DCGI and permitted Chouksey to approach the said authority by way of making an additional representation, bringing to his notice the material and documents submitted before the Court.

The Court directed that the additional representation shall be in addition to the representation already submitted on April 18 and the same shall be submitted within a fortnight.

“In case such an additional representation is preferred enclosing all the documents and material necessary for addressing the issue raised in the writ petition, the same shall be attended to and considered appropriately and as per law by the authority concerned,” the Court said.

It directed the DCGI to take appropriate decision in the matter and to address the concerns raised by Choukset. The decision shall be taken by DCGI within three months, it added.

“We further direct that while considering the issue raised by the petitioner, the DCGI shall consult experts as also other stakeholders such as manufacturers of the drugs in question. The writ petition is disposed of in the aforesaid terms,” the Court said.

Title: Jitendra Chouksey v. Union of India & Anr