CDSCO India Regulatory Software | SUGAM Portal, Revised Schedule M & Form 28 RIM
Novaqis RIM provides end-to-end regulatory compliance and license lifecycle management for Indian pharmaceutical manufacturers, loan-license brand marketers, and merchant exporters interacting with the Central Drugs Standard Control Organisation (CDSCO) and State Licensing Authorities (SLAs). The platform tracks SUGAM portal filings, monitors Form 25/28 manufacturing and loan-license renewal cycles, manages Certificate of Pharmaceutical Product (COPP) renewals, and enforces CDSCO Revised Schedule M computerized data integrity controls out-of-the-box.
CDSCO (India)
CDSCO Compliance Mandate & Novaqis Solution
How Novaqis Regulatory Information Management (RIM) automates statutory compliance, dossier compilation, and packaging serialization for Central Drugs Standard Control Organisation.
| Compliance Dimension | CDSCO Statutory Mandate | Novaqis Automated Solution |
|---|---|---|
| Manufacturing & Loan-License Lifecycles | Form 25 (non-biologicals) and Form 28 (biologicals/large volume parenterals) manufacturing and loan-licenses require strict 5-year renewal tracking and product endorsement management. | Granular product endorsement repository linking each approved brand and generic formulation to its specific manufacturing block, license number, and SLA approval letter. |
| COPP & Export Clearance Governance | Certificates of Pharmaceutical Product (COPP) issued under WHO-GMP certification expire every 3 years and must be renewed to maintain overseas merchant export clearances. | Automated COPP expiration countdown with document packs compiling stability summaries, validation evidence, and batch records for joint CDSCO-SLA inspections. |
| Revised Schedule M Computerized Validation | Revised Schedule M mandates computerized systems validation, automated audit trails (ALCOA+), and strict change control enforcement across manufacturing and testing records. | Native database-level 21 CFR Part 11 and Revised Schedule M compliance with immutable ALCOA+ audit trails, cryptographic e-signatures, and zero per-user seat penalties. |
| Top 300 Brands QR Code Mandate | Domestic finished formulations listed among the top 300 brands must print an authenticated 2D QR code containing unique product identifier, brand name, batch, manufacturing, and expiry date. | Packaging proofing tool validating QR code presence, resolution, quiet zones, and text legibility on printed cartons and blister foils. |
Manufacturing & Loan-License Lifecycles
Form 25 (non-biologicals) and Form 28 (biologicals/large volume parenterals) manufacturing and loan-licenses require strict 5-year renewal tracking and product endorsement management.
Granular product endorsement repository linking each approved brand and generic formulation to its specific manufacturing block, license number, and SLA approval letter.
COPP & Export Clearance Governance
Certificates of Pharmaceutical Product (COPP) issued under WHO-GMP certification expire every 3 years and must be renewed to maintain overseas merchant export clearances.
Automated COPP expiration countdown with document packs compiling stability summaries, validation evidence, and batch records for joint CDSCO-SLA inspections.
Revised Schedule M Computerized Validation
Revised Schedule M mandates computerized systems validation, automated audit trails (ALCOA+), and strict change control enforcement across manufacturing and testing records.
Native database-level 21 CFR Part 11 and Revised Schedule M compliance with immutable ALCOA+ audit trails, cryptographic e-signatures, and zero per-user seat penalties.
Top 300 Brands QR Code Mandate
Domestic finished formulations listed among the top 300 brands must print an authenticated 2D QR code containing unique product identifier, brand name, batch, manufacturing, and expiry date.
Packaging proofing tool validating QR code presence, resolution, quiet zones, and text legibility on printed cartons and blister foils.
How Novaqis Empowers Indian Pharma Exporters & Virtual Marketers
Whether operating dedicated manufacturing facilities or marketing products via loan-license CDMO partners, Indian pharma leaders rely on Novaqis to bridge regulatory approvals with shop-floor batch release.
SUGAM & SLA Application Milestone Tracker
Track technical queries, clinical trials submissions (CT-20/23), and new drug approvals from submission to technical committee review.
Multi-CDMO Loan-License Collaboration
Provide third-party contract manufacturing sites with zero-fee external portals to upload batch testing records, COPP applications, and shade card sign-offs.
Revised Schedule M Audit Readiness
Produce comprehensive, tamper-evident audit trail manifests for joint CDSCO and State Drug Control inspections in seconds.
CDSCO Submission & Compliance Inquiries
Technical guidance on local submissions, dossier structuring, and packaging inspections.
How does Novaqis support virtual pharma and loan-license operators in India?↓
Does Novaqis comply with India's CDSCO Revised Schedule M guidelines?↓
Explore Neighboring Export Jurisdictions
Saudi Food and Drug Authority
Novaqis RIM provides end-to-end regulatory lifecycle management for pharmaceutical manufacturers and merchant exporters submitting to the Saudi Food and Drug Authority (SFDA). The platform automates Saudi eCTD Module 1 administrative workflows, monitors 5-year Marketing Authorization renewal deadlines with automated 180/90/30-day alerts, and bridges approved bilingual Arabic/English Package Inserts directly with RSD Tatmeen GS1 DataMatrix packaging serialization.
GCC & MENA Health Authorities
Novaqis RIM centralizes regulatory lifecycle operations across GCC and MENA health authorities, including UAE MOHAP, Egypt EDA, Jordan JFDA, and Oman MOH. The platform manages multi-country Marketing Authorizations, coordinates Gulf Health Council (GHC) centralized tenders, automates bilingual Arabic/English packaging variations, and tracks regulatory submissions across transitioning eCTD and NeeS formats.
ASEAN Health Authorities
Novaqis RIM streamlines pharmaceutical market authorizations across Southeast Asia by natively structuring ASEAN Common Technical Dossiers (ACTD Parts I–IV) for NPRA Malaysia, BPOM Indonesia, FDA Philippines, and TFDA Thailand. The system manages Zone IVb stability testing protocols, tracks localized labeling variations (Bahasa Melayu, Bahasa Indonesia, English, Thai), and provides automated 180/90/30-day renewal warnings for all ASEAN export licenses.
Ready to Automate Your CDSCO Submissions?
Eliminate missed 5-year renewal deadlines, avoid packaging customs rejections, and coordinate external CDMOs under complete 21 CFR Part 11 audit trails.