Novo Nordisk to Discontinue Multiple rDNA Insulin Products in India
The CDSCO's expert panel consented for firm's proposal for discontinuation of products noting that alternative therapies are available in Indian market.
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has given its consent to Novo Nordisk (India) Private Limited for the discontinuation of multiple Insulin (recombinant DNA origin) drug products from the Indian market.
The discontinuation, as noted, is a business decision and does not affect the safety or efficacy of insulin therapies currently available in India, as the committee has confirmed the availability of alternative therapies.
The matter was discussed at the SEC meeting held on August 20, 2025, at CDSCO headquarters in New Delhi. Novo Nordisk presented its proposal to discontinue several of its Insulin drug products manufactured using recombinant DNA technology.
The committee noted that, "the firm has proposed for the discontinuation of products based on a business decision and not due to any safety or efficacy concerns and further noted that alternative therapies are available in Indian market.”
After detailed deliberation, the committee consented for firm’s proposal for discontinuation of their multiple Insulin drug products (rDNA origin) from Indian market.
Insulin is a vital hormone used to manage blood sugar in patients with type 1 diabetes and in many with advanced type 2 diabetes. Recombinant DNA (rDNA) technology allows large-scale production of human insulin and insulin analogues with high purity.
Novo Nordisk, a Denmark-based pharmaceutical major, has been a pioneer in developing and supplying insulin worldwide, including various human insulin, basal, rapid-acting, and premixed insulin products. Novo Nordisk has been one of the key suppliers of insulin in India, providing various formulations for diabetes care.
