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Informist, Tuesday, Jun. 2, 2026

 

NEW DELHI – The Delhi High Court has asked the Central Drugs Standard Control Organization to decide on a petition that raised apprehension on the regulator giving approval to Zydus Lifesciences Ltd. for manufacturing and marketing semaglutide injection. The court was hearing a plea by Jyoti Shrivastava, a diabetes patient, who said that Zydus departed from established global practice of using pre-filled, pre-calibrated pen devices with fixed dose increments, opting instead for a uniform formulation lacking calibrated delivery safeguards. Zydus had marketed its semaglutide injection under the brand names "Semaglyn", "Alterme" and "Mashema".

 

Looking at the nature of the controversy involved herein, the court deems it appropriate to allow Shrivastava to file a detailed representation before the Central Drugs Standard Control Organization pointing out the difficulties which the petitioner has suffered and that similar other patients are likely to experience, said Justice Purushaindra Kumar Kaurav. After receiving the petitioner's representation, Central Drugs Standard Control Organization shall consider it and decide by way of a speaking order within a period of two months.

 

Shrivastava said that she had faced serious confusion regarding extraction and administration of the prescribed dose from the uniform high strength cartridge. The product design, common prescribing information, and absence of indication-specific dose safeguards created genuine apprehension regarding safe administration of the drug, thereby exposing the patient to significant health risks, said Shrivastava.

 

Semaglutide is a medicine used for treatment of two health issues namely Type 2 Diabetes and weight loss. This medicine is considered sensitive and must be started in a very small dose and gradually increase over several weeks in order to minimise severe adverse effects and ensure patient safety, the petition stated. This gradual increase is called "dose titration", it said. Globally, such medicines are sold in specially designed pens that automatically give fixed and safe doses to patients, it said.

 

Zydus has launched the medicine in a single high strength formulation, where patients themselves have to manually calculate and select the required dose using a reusable pen and extract the dosage from a cartridge, said the petitioner. This creates risk of overdose, underdose, wrong administration, confusion between diabetes and weight loss use, and severe health complications, said the petitioner. 

 

Type 2 Diabetes Mellitus and chronic weight management are distinct therapeutic indications requiring separate titration schedules, dosing pathways, maintenance doses, and clinical evaluation, said the petitioner. However, Zydus has commercialised a common formulation and delivery system across both indications, despite approval recommendations being based upon separate clinical studies and indication-specific data, it said.

 

The approval by Central Drugs Standard Control Organization to Zydus is arbitrary, unsafe, and violative of Articles 14 and 21 of the Constitution of India, said Shrivastava. Central Drugs Standard Control Organization had failed to adequately examine whether the approved formulation aligns with the clinically validated titration-based framework forming the basis of Semaglutide's safety and efficacy, said Shrivastava. Accordingly, the petitioner sought quashing of the approval granted to Zydus for manufacture and marketing of semaglutide injection, disclosure of the complete approval records and evaluation materials, and restraint against further manufacture and sale of the products in their present form and manner.

 

At 1124 IST, shares of Zydus Lifesciences Ltd. were down 1.7% at INR 1,072.90 on the National Stock Exchange.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Reported by Surya Tripathi

Edited by Deepshikha Bhardwaj

 

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