| |SEPTEMBER 20259DoP TIGHTENS NORMS ON FREE SAMPLES BY MED DEVICE MAKERSNOVO NORDISK TO END RDNA INSULIN PRODUCT SALES IN INDIAAs part of the uniform code for marketing practices, manufacturers of medical devices are allowed to give doctors free evaluation samples so they can get firsthand experience using the product.However, the samples must be valued per unit and their value must match the price charged to the stockist or immediate customer per unit for the same make, brand, product variant, and value of the medical device.The monetary value of free evaluation samples should be calculated using the purchase price if the company bought the samples from another source.The average price paid for the purchase of a medical equipment of the same make, brand, product variant, and value on an annual basis, or the average price charged to the stockist or immediate client, should be used to record the cost of such free samples.A year after notifying the medical device for healthcare industry that the Uniform Marketing Code will be adopted, the Department of Pharmaceuticals (DoP) streamlined the reporting process to determine the value of free assessment samples sent to medical practitioners.Additionally, the DoP has mandated that the CEO of the organization be in charge of upholding the code. According to the circular, "the executive head of the firm must submit the disclosure of marketing spending within two months after the end of each fiscal year or upload it to the website of the Association of which the company is a member". PONovo 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.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. PO
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