CDSCO Cosmetics

The application process is now almost entirely online through the SUGAM Portal (for drugs/cosmetics) or the Online System for Medical Devices. Register: Create an account on the CDSCO SUGAM Portal. Document Upload: Upload the required legal and technical documents (see Q10). Form Submission: Fill out the specific application form (e.g., Form 40 for Registration Certificate, Form MD-X for devices). Payment: Pay the requisite fee via the Bharat Kosh portal. Review: The CDSCO officials will review the application and may ask for queries. Grant: Once approved, the license is generated online.

Fees for CDSCO applications are paid through the Bharat Kosh (Non-Tax Receipt Portal) website. Visit Bharat Kosh. Select “Non-Registered Users” (or login if you have an account). Select Ministry/Department: “Health & Family Welfare”. Select Purpose: Choose the specific fee type (e.g., “Drug Import License Fee” or “Medical Device Fee”). Enter the amount and your details. Pay via Net Banking, Debit/Credit Card, or UPI. Important: Save the Challan/Receipt; you must upload this on the SUGAM portal as proof of payment.

The cost varies significantly based on the product and activity: Medical Device Manufacturing: Class A & B: ₹5,000 (Site) + ₹500 (Per Product). Class C & D: ₹50,000 (Site) + ₹1,000 (Per Product). Import License (Drugs): $1000 to $5000 (approx) depending on the number of drugs and manufacturing sites. Retail/Wholesale Drug License: State-level fees usually range from ₹3,000 to ₹5,000 (Government Challan fee), excluding professional consultant fees.

No. Selling medicines without a valid license is a criminal offense under the Drugs and Cosmetics Act, 1940. Penalty: It can lead to imprisonment (from 1 year up to life term depending on the severity) and heavy fines.

Retail/Wholesale Drug License: Typically valid for 5 years (renewed thereafter). Import License (Form 10): Valid for 3 years. Manufacturing License: Valid for 5 years. Medical Device License: Often valid in perpetuity, provided you pay a retention fee every 5 years to keep it active.

To start a retail pharmacy (medical shop), you need to apply for a Retail Drug License from your State Drug Control Department (not directly CDSCO, though rules are central). Requirements: Premises: Minimum 10 sq. meters carpet area. Pharmacist: You must employ a registered pharmacist (B.Pharm or D.Pharm holder) full-time. Storage: A refrigerator to store vaccines/insulin. Application: Apply to your state’s Drug Inspector office with rent agreement, pharmacist’s certificate, and fees.

If you are asking about the Retail Drug License (for a medical shop): Government Fee: Approx ₹3,000 – ₹4,000. Total Setup Cost: Opening a shop requires ₹3 Lakh to ₹7 Lakh (Rent, Furniture, Fridge, Stock/Medicines, Computer).

A Free Sale Certificate (FSC) is required to export medical devices/drugs to show they are freely sold in India. Login to the SUGAM Portal or CDSCO Medical Device Portal. Navigate to the “Export” or “FSC” section. Upload your valid Manufacturing License and the list of products. Upload a Notarized Undertaking stating the products are not banned. Pay the fee (approx ₹250 per product). Upon approval, the certificate is issued online.

The documents depend on the license type, but common ones include: For Manufacturing/Import: Covering Letter & Authorization Letter. Power of Attorney (for importers). Plant Master File (Factory layout, machinery details). Device Master File (for medical devices). ISO 13485 Certificate (Quality Management). Free Sale Certificate from the country of origin (for importers). For Retail Drug License: Rent agreement/Ownership proof of premises. Pharmacist Registration Certificate & Affidavit. Blueprint/Layout of the shop. Refrigerator purchase bill.