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Importance:
The Central Drugs Standard Control Organization (CDSCO) regulates drugs, cosmetics, and medical devices in India to ensure safety, efficacy, and quality. Any company dealing in these products must obtain CDSCO approval before marketing in India.
Benefits
- Legal right to manufacture, import, and sell in India
- Builds consumer and healthcare provider trust
- Reduces regulatory risks, seizures, or bans
- Strengthens global credibility for exports
- Ensures alignment with Good Manufacturing Practices (GMP)
Categories of CDSCO Registration
1. Drugs & Pharmaceuticals
Manufacturers or importers of drugs must obtain approval for new drugs, formulations, or bulk drugs. CDSCO regulates:
- New Drug Approval (NDA)
- Clinical trial approvals
- Import and manufacturing licenses
2. Medical Devices
- India has classified medical devices into four categories (A, B, C, D) based on risk. CDSCO registration is mandatory for both domestic and foreign manufacturers.
3. Cosmetics
- Cosmetic importers and manufacturers require registration under CDSCO before launching products in India.
4. Clinical Trials
- Any company or research institution conducting clinical trials in India must secure prior approval from CDSCO.
Why It Is Required?
- CDSCO approval is mandatory under Indian law for drugs, cosmetics, and all medical devices.
- Without registration, products cannot be marketed in India.
- Ensures that only safe and effective products reach consumers and patients.
Who Should Get It?
- Pharmaceutical companies (domestic & foreign)
- Cosmetic brands (skin care, hair care, personal care, etc.)
- Medical device manufacturers (from syringes to complex machines)
- Importers & distributors seeking to bring international products into India
How SKJ Business Solutions LLP Helps
At SKJ Business Solutions LLP, we provide end-to-end CDSCO Compliance & Registration consultancy for Indian and foreign companies.
Our services include:
- Guidance on product classification and applicable CDSCO norms
- Documentation support for drugs, medical devices, and cosmetics
- Assistance with online application filing through the SUGAM portal
- Liaison with CDSCO authorities for faster approvals
- End-to-end compliance management for Indian and foreign businesses
- Post-approval compliance and renewal support
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