As global regulators flag shortages involving semaglutide in injectable and oral versions, there are concerns whether the impact could spill over into India as well.

Novo Nordisk’s oral semaglutide (Rybelsus), touted to be a game-changer in treating Type 2 diabetes, was launched early last year in India. The pill is marketed in three strengths (3, 7 and 14 mg), and is finding takers despite its high price (about Rs 10,000 a month), diabetologists said.

However, patients are finding that Rybelsus is sometimes out of stock in a particular strength, according to some chemists and diabetologists. And while this may still be a small number, it is unclear how the global pressure on supplies could impact India.. 

The two injectable products, Ozempic and Wegovy, have not been launched in India, but their international popularity has put pressure on the supply of the active ingredient, semaglutide.

FDA inspections

Adding to the uncertainty, the Novo Nordisk plant in the US that makes semaglutide had recently faced strict regulatory action from the US Food and Drug Administration (USFDA), foreign media reports said.

“Following the FDA’s inspection in July 2023, we have responded to their observations and the site is running and producing for the market,“ Novo Nordisk told businessline, in response to queries on the impact these developments could have on oral semaglutide supplies in India.

Concerned about continuity of the medication, diabetologist Rajiv Kovil said the 3 mg tablet was available, but patients were facing difficulties in getting the 7 and 14 mg versions. Availability has been impacted for the last two to three months, he said. Patients are started on the 3 mg pill and upgraded to 7 mg, said Dr Kovil, who is with Mumbai’s Zandra Healthcare.

Dr V Mohan, Chairman, Dr Mohan’s Diabetes Specialities Centre, Chennai, explains that semaglutide belongs to the GLP-1 receptor analogue class. Its injectable forms “resulted in quite profound weight loss and, for this reason, became very popular in the US. In fact they are so popular that they are not available to meet the US market needs,” he says. However, the three strengths of the oral drug are available in India, he added. 

Delhi-based Dr Saptarshi Bhattacharya, Senior Consultant (Endocrinology) with Apollo Hospitals, added that the product was largely available, though a couple of patients did report difficulties in getting certain strengths.

Global ‘intermittent’ shortages

In July, the European Medicines Agency had cautioned healthcare professionals in the European Union to expect “intermittent shortages” of oral semaglutide till the end of the year, due to an increase in demand for the drug. In an update last week, Australian regulator, Therapeutic Goods Administration (TGA), said that, regarding Ozempic (semaglutide), the company had advised that “supply throughout the rest of 2023 and 2024 will be limited”.