Accessing the massive Indian market with consumables or medical products requires strict approval from the Central Drugs Standard Control Organization (CDSCO) and the Food Safety and Standards Authority of India (FSSAI). The Ministry of Health and Family Welfare enforces rigorous safety standards to protect the public. No regulated product can enter India or be manufactured locally without proceeding through these centralized statutory portals.
Role of CDSCO & FSSAI
CDSCO is India's national regulatory body for pharmaceuticals, medical devices, and cosmetics. FSSAI operates under the Ministry of Health to lay down science-based standards for articles of food and to regulate their manufacture, storage, distribution, sale, and import.
SUGAM & FoSCoS Portals: CDSCO utilizes the SUGAM portal for e-Governance of drug and device licensing, while FSSAI heavily uses the FoSCoS (Food Safety Compliance System) ecosystem for Pan-India food business lifecycle management.
Core Registration Services
We manage the highly technical end-to-end registration processes on the Indian government portals.
- 🩺Medical Devices (CDSCO) Obtaining Import Licenses (Form MD-15) or Manufacturing Licenses under the Medical Device Rules, 2017.
- 💄Cosmetics Import Registering cosmetic products on the SUGAM portal to obtain the vital Form 43 Import Registration Certificate.
- 🏭FSSAI Central License Securing the 14-digit FSSAI Central License mapping for importers, large manufacturers, and export units.
- 🍎FSSAI Product Approval Navigating the Non-Specified Food (NSF) approval process for novel foods or unclassified health supplements.
Registration Architecture
Establishing an Indian health or food product requires strict, sequential scientific adherence:
Regulated Sectors
- Pharmaceuticals & API Imports
- Medical Devices, IVDs & Equipment
- Food Supplements & Nutraceuticals
- Cosmetics & Personal Care
- Food Importers & Cloud Kitchens
- Novel & Proprietary Foods
Key Compliance Bottlenecks
Indian health authorities have zero tolerance for deviations on critical compliance elements:
A mandatory requisite for foreign pharma/device brands to ensure strict local accountability and pharmacovigilance.
High-risk devices (Class C/D) or unapproved new drugs definitively require local clinical trials in India before approval.
Imported food packaging strictly must display the FSSAI logo, license number, veg/non-veg mark, and precise nutrition facts.
Market Advantages
- Government Tenders Only fully CDSCO-approved medical devices can be supplied to massive government hospital networks and Ayushman Bharat.
- ICEGATE Customs Speed Both SUGAM and FoSCoS are digitally linked with Indian Customs (ICEGATE) for rapid, automated port clearance validation.
- Consumer Trust Displaying an FSSAI or CDSCO license is the ultimate, legally binding seal of safety for the Indian demographic.