The Central Drugs Standard Control Organisation (CDSCO) issued a sweeping enforcement action on January 16, 2026, threatening to reject thousands of pending regulatory applications — some dating back 8-10 years. This unprecedented move, combined with new IVD import guidance and aggressive cosmetic enforcement, signals a fundamental shift in CDSCO’s regulatory approach for 2026.
CDSCO’s Application Rejection Ultimatum: February 14 Deadline
Citing a massive backlog of unanswered applications on the SUGAM Portal, CDSCO issued a final warning on January 16, 2026. Applications pending for more than two years that have received three reminders must respond by February 14, 2026, or face automatic rejection.
New 90-Day Response Rule Takes Effect
Moving forward, CDSCO will enforce a strict timeline:
- First reminder issued for unanswered regulatory queries
- Second and third reminders follow at 30-day intervals
- Applications rejected if no response within 90 days of first reminder
This affects all product categories — drugs, medical devices, and IVDs. Companies with pending applications should immediately check their SUGAM Portal status and respond to outstanding queries.
New IVD Import Guidance Document Released
In January 2026, CDSCO released a draft guidance document titled “Guidance for Import of In-Vitro Diagnostic Medical Device” (No. CDSCO/IVD/GD/DRAFT/IMP/01/2026) to clarify import requirements for IVD manufacturers.
Key Changes in IVD Import Process
The new guidance addresses critical gaps in the regulatory framework:
- Detailed procedural direction for different license types
- Submission expectations through CDSCO online system and National Single Window System (NSWS)
- Specific checklist items for import applications
- Stakeholder feedback period: 15 days from publication
This development comes as IVD manufacturers have struggled with unclear import pathways. The guidance aims to streamline submissions while maintaining compliance standards.
Cosmetic Import Crackdown Intensifies
March 2026 brought significant enforcement actions against cosmetic importers, with courts and CDSCO taking increasingly strict positions.
Bombay High Court Blocks Re-Export of Seized Cosmetics
On March 9, 2026, the Bombay High Court ruled that cosmetics imported without mandatory CDSCO registration qualify as “prohibited goods” under the Customs Act, 1962. The court refused to permit re-export of seized consignments, even for goods intended for warehousing and re-export.
Beauty Garage License Cancelled for Formaldehyde Violation
CDSCO cancelled Registration Certificate no. RC/COS-005358, Endorsement No. 3 on March 16, 2026, after finding high formaldehyde concentrations in Beauty Garage India Private Limited’s products. The certificate, issued April 25, 2025, was valid until August 26, 2029.
The Directorate of Revenue Intelligence (DRI) also alleged gross undervaluation in another case — while the importer declared goods worth ₹1.64 crore, government valuers assessed them at over ₹10 crore.
Updated Processing Timelines for 2026
CDSCO has clarified processing timelines for medical device licenses:
- MD-5 License (Class A and B Devices): 3-6 months
- MD-9 License (Class C and D Devices): 9-12 months
- MD-15 Import License: 6-9 months
Remember: As of October 1, 2023, all medical devices (Class A Measuring and Sterile, B, C, and D) require an MD-14/15 Import License for importation into India.
Immediate Action Items for Businesses
For Pending Applications
- Check SUGAM Portal immediately for outstanding queries
- Respond to all pending inquiries before February 14, 2026
- Prepare comprehensive responses to avoid future 90-day rejection cycles
For IVD Manufacturers
- Review the new draft guidance document (CDSCO/IVD/GD/DRAFT/IMP/01/2026)
- Submit feedback within the 15-day comment period
- Align import strategies with updated submission requirements
For Cosmetic Importers
- Ensure all products have valid CDSCO registration before import
- Verify ingredient compliance, particularly formaldehyde content
- Review valuation declarations for accuracy
Compliance Consequences
The enforcement actions demonstrate CDSCO’s zero-tolerance approach. Companies face:
- Product confiscation and import bans
- Criminal charges for non-compliance
- Mandatory public recalls
- License cancellations without refund
The BIS Scheme X Certification extension to September 1, 2026, under the omnibus technical regulation order 2024, provides some relief, but companies should prepare for stricter enforcement across all regulatory frameworks.
Strategic Recommendations
The January-March 2026 developments signal CDSCO’s commitment to clearing backlogs while maintaining strict compliance standards. Companies should:
- Establish proactive SUGAM Portal monitoring systems
- Engage with CDSCO early in product development cycles
- Invest in comprehensive regulatory compliance programs
- Prepare for longer processing times and stricter documentation requirements
ACPL’s regulatory experts can help you navigate these complex CDSCO requirements and ensure compliance with the latest enforcement actions. Contact us at info@acplgroupindia.co.in or call +91-9266665201 for a consultation.