The Indian drug regulator has approved the highest number of new drugs based on r-DNA origin, both for imports and manufacturing in the country during the year 2025, compared to the previous five years.
According to the data from the Central Drugs Standard Control Organisation (CDSCO), a total of 28 new drugs (r-DNA origin) were approved for manufacture and marketing in India during 2025, as compared to 20 approved in the previous year.
During the year 2023, a total of 17 r-DNA origin new drugs were approved for manufacturing and marketing, compared to 12 in 2022, 22 in 2021, and eight in 2020.
The drugs approved for manufacturing and marketing in 2025 include 11 formulations from Eris Lifesciences, with 10 insulin products to treat diabetes mellitus, such as, isophane insulin injection, insulin injection soluble insulin neutral (regular), biphasic isophane insulin injection, insulin glargine injection, insulin injection soluble insulin (neutral), and a formulation nimotuzumab injection (humanized anti-EGFR monoclonal antibody), to treat head and neck cancer.
The other formulations approved during the year include Aflibercept 40 mg/mL (2mg/0.05mL) (r-DNA origin), rituximab 100 mg/10 mL and 500mg/50mL (10mg/mL) (r-DNA origin), and bevacizumab (approval for additional strength) from Zydus Lifesciences, pertuzumab, drug substance and drug product from Intas Pharmaceuticals, denosumab formulated drug substance (r-DNA origin) 70mg/mL from Hetero Biopharma Ltd, rituximab injection 500mg/50mL and 100 mg/10mL (r-DNA origin) from Virchow Biotech, two strengths of trastuzumab lyophilised powder for injection (150 mg and 440 mg) from Biocon Biologics Ltd, among others.
According to the data from the central drug regulator, a total of 44 new drugs (r-DNA origin) were approved for import and marketing in India during 2025, as compared to 26 approved in the previous year.
During the year 2023, a total of 31 r-DNA origin new drugs were approved for import and marketing, compared to 17 in 2022, 23 in 2021, and 14 in 2020.
The drugs approved for import and marketing in 2025 include eculizumab, datopotamab deruxtecan, and approval of additional indication for durvalumab, trastuzumab deruxtecan, and benralizumab for AstraZeneca Pharma, Insulin Icodec, concizumab, semaglutide injection, and approval for additional indication for semaglutide injection for Novo Nordisk, antihemophilic factor (recombinant factor VIII) I.P. 250 IU, 500 IU, 1000 IU, 2000 IU, 3000 IU vial for Bayer Pharmaceuticals, FDC of nivolumab and relatlimab, and approval of additional indication for luspatercept, nivolumab, Ipilimumab for Bristol-Meyer Squibb India.
Import approval was also issued for tislelizumab to Glenmark Pharmaceuticals, serplulimab to Intas Pharmaceuticals, tildrakizumab injection (r-DNA origin) to Sun Pharmaceuticals, and Aflibercept to Biocon Biologicals, among others.
Approval for new drugs of r-DNA origin for manufacture and marketing in the country is issued against application of the company in Form CT-21, requesting grant of permission to manufacture new drug formulation for sale or for distribution.
Approval for new drugs of r-DNA origin for import and marketing in the country is issued against application of the company in Form CT-18, requesting grant of permission to import new drug for sale or for distribution.
