1. Business Registration and Premises Setup
Register your business entity (company, LLP, or proprietorship) and secure your manufacturing premises in Delhi NCR. The premises must be in a sanitary location — not connected to residential areas. Have your site plan drawn to scale per Schedule M-II requirements before proceeding. Simultaneously, obtain GST registration and keep all business documents current.
2. GMP Compliance Gap Analysis
Assess your facility against Schedule M-II GMP requirements — before submitting any application. Identify gaps in manufacturing areas, QC setup, storage segregation, hygiene facilities, and documentation systems. Close all gaps proactively. The Delhi Drug Control Department inspects your premises — what inspectors find must match your COS-7 self-declaration exactly. Gaps discovered during inspection can result in licence refusal or suspension.
3. Appoint Qualified Technical Staff
Appoint at least one full-time qualified technical person holding the required educational credentials. Prepare appointment letters, qualification certificates, experience documentation, and Pharmacy Council registration proof (for D.Pharm holders). The Delhi Drug Control Department verifies that qualified technical staff are actually employed — not just listed on paper. This is a common inspection check point.
4. Prepare Complete Document Dossier
Compile all documents — business registration, site plan, product list (categorized per Schedule M-II), equipment list, Site Master File, SOPs, COS-7 self-declaration, technical staff credentials, and label artwork. Every document must be current, accurate, and cross-consistent. Inconsistencies between documents trigger queries and delay your application significantly.
5. Submit COS-5 Application to Delhi Drug Control Department
Submit Form COS-5 along with Form COS-7 self-declaration, all supporting documents, and applicable fee payment to the Delhi Drug Control Department. The State Licensing Authority is mandated to grant a Manufacturing Licence within forty-five days from the date of application after scrutinizing the submitted application and documents. Keep your application acknowledgement number for all follow-up communications.
6. Application Scrutiny and Query Response
The Delhi Drug Control Department scrutinizes your submitted application and documents. If deficiencies are found, a query is raised. Respond completely with corrective documentation — partial responses lead to repeat queries and extended timelines. Your response must address every point raised with documentary evidence, not just written explanations.
7. Site Inspection by Delhi Drug Control Department
Within 30 days of licence issuance, the SLA may inspect the manufacturing premises to verify the information in the submitted GMP self-certificate (Form COS-7). If the self-certificate contains false information, the licence may be cancelled. If correctable deficiencies are identified, the SLA will direct the licensee to stop manufacturing until the issues are resolved. If the SLA does not conduct the inspection within 30 days, the licence is considered valid for all purposes.
8. COS-8 Issued — Upload to CDSCO and Begin Manufacturing
After obtaining the licence, upload it to the CDSCO website for transparency. Your COS-8 licence number must appear on every product label as “Mfg. Lic. No. …”. Your licence is valid for lifetime — provided the retention fee is paid every 5 years. You may now legally begin manufacturing the products listed in your approved COS-5 application.