In a bid to ease regulatory compliance and enhance the ease of doing business, the Central Drugs Standard Control Organisation (CDSCO) will launch a new online system for issuing No Objection Certificates (NOCs) for bulk drug imports intended for non-medicinal use. The digital system, to go live on the Sugam Portal from August 31, 2025, aims to simplify the dual-use NOC process by making it entirely online and reducing manual intervention. NOCs will be valid for one year, subject to prescribed conditions. The CDSCO has also issued a detailed guidance document outlining the updated procedure and documentation requirements under Rule 43 of the Drugs and Cosmetics Rules, 1945.

According to a circular issued by the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, applicants will need to complete a fresh registration process on the Sugam Portal and submit a checklist of required documents, including address proof, identity proof of the authorised person, and an undertaking. Only users registered and approved by the CDSCO as dual-use NOC traders or actual manufacturers will be allowed to apply from September 2025.

The dual-use NOC process involves two steps. First, the applicant must register and apply for the NOC at the concerned zonal or sub-zonal CDSCO office. Second, once the NOC is obtained, the applicant must submit final import documentation online and at the port office, including the Certificate of Analysis, bill of entry, original product label, and purchase invoice. The clearance must be applied for at least two months before import to avoid delays. Additional requirements include a Master Formula Record attested by the Licensing Authority. However, imports meant for sterilization or purification are not eligible under the dual-use provision.

The guidance document clarifies the eligibility criteria, documentation, and regulatory procedures for importers using drugs in non-medicinal applications such as pharmaceuticals, food processing, and animal feed. Each application will undergo a technical review by the Deputy Drugs Controller (India) of the respective CDSCO zone. This initiative is expected to streamline bulk drug imports for non-medicinal use and reduce compliance-related delays for industries.