India Pharma Outlook Team | Friday, 05 September 2025
Novo Nordisk India’s proposal to discontinue several recombinant DNA (rDNA) origin insulin products from the Indian market has been approved by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO).
The company also declared that it was simply a business decision and nothing else. The SEC states that the supply of alternative insulin treatments is very feasible in India and therefore no problem of caring continuity would be faced by patients who depend on insulin. The issue was discussed at the SEC meeting held on August 20, 2025, at CDSCO headquarters, New Delhi, where Novo Nordisk shared its plan for withdrawing multiple rDNA insulin formulations.
The committee heard that the possible discontinuation does not affect safety as there are already substitutes for this purpose in the local market. Insulin therapy is still the mainstay in type 1 diabetes and late-stage type 2 diabetes. Recombinant DNA technology has allowed mass production of human insulin and insulin analogues of very high purity, which has essentially changed diabetes treatment all over the world.
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Novo Nordisk, Denmark-based, has brought in a turn-around situation in the insulin market, being the supplier of human insulin, basal, rapid-acting, and premixed insulin products. In India, the company has been a major player, supporting millions of diabetic patients with easy-to-use and safe-access formulations. The withdrawal will result in the loss of some products from the company’s portfolio, but the experts say it will not severely affect patients as the availability of alternative insulin options will continue.