The Central Drugs Standard Control Organisation (CDSCO) has eased export requirements for recombinant DNA (r-DNA) drugs, clarifying that manufacturers will no longer need a separate export no-objection certificate (NOC) for products marketed overseas under different brand names, provided they already hold valid marketing authorisation in India. According to reports from Business Standard, Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi issued a notice to state drug controllers stating that a separate export NOC may not be required if there is no change in the approved composition, specifications, strength, dosage form, presentation, packaging configuration, manufacturing site, process or any other critical particulars. The exemption will apply only to products with valid marketing authorisation and no changes to their approved characteristics.
Eligible manufacturers can now directly submit applications for the necessary product permissions to the concerned State Licensing Authority (SLA) through the online licensing system, without first obtaining a separate export NOC from CDSCO. As reported by Business Standard, this move is expected to reduce export approval timelines for biologics manufacturers by eliminating an additional regulatory clearance for products whose approved specifications and manufacturing processes remain unchanged. The clarification follows queries from pharmaceutical manufacturers on whether a separate export NOC was necessary when an already authorised product was being exported under a different brand name. Applications may be submitted through the ONDLS portal to the concerned State Licensing Authority and processed as per applicable regulatory requirements.
The clarification is significant for manufacturers of recombinant biologics, including monoclonal antibodies, insulin analogues, recombinant hormones and growth factors, which are used in treating conditions such as cancer, diabetes and autoimmune diseases. According to CDSCO data reported by Business Standard, the regulator approved over 100 new r-DNA-origin drugs between 2020 and 2025 for import and domestic manufacture, covering finished formulations as well as bulk drug substances. These include monoclonal antibodies, recombinant hormones, growth factors, insulin analogues and immunotherapies used in cancer treatment.
The latest decision follows earlier efforts by the drug regulator to streamline approval procedures for recombinant biologics. In March this year, CDSCO directed that applications for manufacturing licences for r-DNA products be submitted through the Online National Drugs Licensing System (ONDLS), replacing the earlier manual, paper-based process. As reported by Business Standard, the transition to online submissions was aimed at simplifying regulatory procedures and improving the processing of applications for manufacturers of these products. The move comes amid growing regulatory activity in India's biologics segment, with domestic manufacturers developing and manufacturing complex biological medicines for both Indian and overseas markets.
