FDA RaQa Solutions Pvt Ltd

11/02/2026

16/10/2025

Strengthening Pharmaceutical Safety Standards in India

In light of recent reports of cough syrup–related fatalities, the Central Drugs Standard Control Organisation (CDSCO) has launched a comprehensive, pan-India initiative to ensure the safety and quality of cough syrup manufacturing.

Key steps include:
✅ Nationwide audit, testing, and inspection of all cough syrup manufacturers
✅ Collection of detailed manufacturer lists from all States and Union Territories
✅ Joint inspections by CDSCO and State FDA teams
✅ Verification of packaging, label warnings, dosage instructions, and contents
✅ Rigorous testing of raw materials used in manufacturing

These actions underscore the government’s and regulators’ strong commitment to patient safety, quality assurance, and compliance across India’s pharmaceutical industry.

15/09/2025

🌍 India’s Regulatory Framework for Pharma & Medical Devices is Evolving

The Central Drugs Standard Control Organization (CDSCO) has announced major regulatory updates that will reshape compliance, streamline processes, and support innovation across the pharma & medical device sector.

🔹 Dual Use NOC – New Digital System

Effective 05.08.2025, applications will move to the Sugam Portal.

From 01.09.2025, only approved Dual Use NOC Traders & Manufacturers can apply.

A simplified 1-year NOC for bulk, non-medicinal imports is introduced—reducing compliance burden while ensuring oversight.

🔹 Medical Device Regulatory Pathway (MDR 2017)
A clear end-to-end roadmap has been laid out for medical devices:
1️⃣ Product Development & Prototype
2️⃣ Test License (Form MD-12/16 → MD-13/17)
3️⃣ Clinical Investigation Permission (Form MD-22 → MD-23)
4️⃣ Import/Manufacturing for Clinical Use (Form MD-26 → MD-27)
5️⃣ Commercialization (MD-3 to MD-10, MD-14/15)

💡 Why this matters?
These reforms are more than just procedural changes. They represent:
✔️ Greater regulatory clarity for stakeholders
✔️ Faster market entry pathways for medical devices
✔️ Strengthened patient safety & product quality
✔️ Improved ease of doing business for the healthcare sector

🔗 Full details & applications available at www.cdscoonline.gov.in

📢 Takeaway: With CDSCO’s proactive steps, India is moving towards a future-ready regulatory ecosystem—one that balances innovation, compliance, and public health safety.

15/09/2025

🚀 Regulatory Pathway for Medical Devices in India (MDR 2017)

Bringing a medical device from prototype to commercialization requires a clear understanding of India’s regulatory framework under the Medical Devices Rules, 2017.

Here’s a simplified flow of the process:
🔹 Product Development / Prototype
🔹 Test License (Form MD-12/16 → License MD-13/17)
🔹 Clinical Investigation Permission (Form MD-22 → MD-23)
🔹 Import/Manufacture of Investigational Device (Form MD-26 → MD-27)
🔹 Manufacturing / Import License for Commercialization (Forms MD-3 to MD-10, MD-14/15)

✅ Covers: R&D, Clinical Investigations, Import, Manufacturing & Compliance requirements.
✅ Ensures: Safety, Quality & Efficacy before devices reach patients.

This pathway is crucial for:
📌 Startups developing innovative devices
📌 Regulatory professionals
📌 MedTech entrepreneurs
📌 Quality & compliance experts

📷 (Infographic attached for clarity)

💡 Question for my network:
What do you think are the biggest challenges MedTech innovators face in navigating India’s regulatory pathway?

15/09/2025

15/07/2025

CDSCO extends deadline for mandatory filing of applications for issue of WHO GMP/CoPP till 15th Aug 2025. However, those already registered may file their applications voluntarily.

17/04/2025

Manufacturing and marketing of unapproved FDCs regarding: DCGI

10/04/2025

Provision for system auto-generated Neutral Code by the manufacturer for the export purpose under Medical Devices Rules 2017: DCG(I)
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI2NDE=

10/04/2025

Provision for auto-generated Market Standing Certificate (MSC) and Non-Conviction Certificate(NCC) for licenced medical device: DCG(I)
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI2NDA=

09/04/2025

Circular on Transfer of Drugs (API/Formulations) from Special Economic Zone (SEZ) to Domestic Tariff Area (DTA): DCG(I)
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI2Mzk=

Highlights