Overview of CDSCO Drugs Import License
The Central Drugs Standard Control Organisation (CDSCO) oversees the import of drug products into India to certify that they are safe, effective, and of good quality. Import of drugs into India is regulated under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, by the CDSCO. The process of import is made seamless through the SUGAM portal, which is the official online platform for offering various regulatory services.
Benefits of CDSCO Drugs Import License
Acquiring a CDSCO Drugs Import License provides a number of important advantages for businesses looking to import pharmaceuticals into India. Here's the rundown of the most important benefits:
1. Legal Authorization
Guarantees adherence to the Drugs and Cosmetics Act, 1940.
Legally authorises importing and distributing drugs in India.
Avoids legal repercussions and fines due to illegal imports.
2. Market Access
Opens up the Indian pharmaceutical market, one of the world's largest and fastest-growing, to foreign manufacturers.
Facilitates companies to diversify their international presence by leveraging Indian demand.
3. Quality Assurance
It issues the license only after a rigorous review of safety, effectiveness, and quality information.
Gains the trust of healthcare professionals and consumers, as it guarantees them regulatory control.
4. Business Credibility
Improves the importer and foreign manufacturer's reputation and credibility.
Generally needed for tenders, joint ventures, or distribution agreements in the pharmaceutical sector.
5. Simplified Customs Clearance
Makes Indian port import procedures smoother.
Lowers the chances of shipment delays, detentions, or rejection by customs officers.
6. Validity and Renewal Convenience
Issued after, the license is usually valid for 3 years and can be renewed with ease.
Streamlines the administrative process of repeated applications.
7. Regulatory Clarity through SUGAM Portal
Online application tracking facility through the SUGAM portal enhances transparency and efficiency.
Less paperwork and better communication with CDSCO.
8. Facilitates Coordination with Indian Agents
Makes the appointment of official Indian agents easier, simplifying logistics, marketing, and distribution.
9. Government Contract Access
A legitimate CDSCO import license might be required for taking part in government procurement tenders for pharmaceuticals
Eligibility to Import Registered Drugs in India
a. Indian Agent
An Indian national or an Indian company registered in India.
Should be empowered by a foreign manufacturer via a Power of Attorney.
Serves as a local representative and takes care of regulatory matters with the CDSCO.
b. Manufacturer's Subsidiary in India
If the foreign firm has a wholly owned subsidiary or joint venture facility in India, it can make a direct application.
c. Importer (Pharmaceutical Company or Distributor)
Should have a valid wholesale license (Form 20B and/or Form 21B) under the Drugs and Cosmetics Rules.
May import and distribute registered drugs in India
Documents Required for CDSCO Drugs Import License
Forms for Import Registration Certificate (Form 41)
1. Application Form (Form 40)
Application by the manufacturer or the manufacturer's authorised Indian agent.
2. Power of Attorney
Legal authority from the manufacturer to the Indian agent.
3. Duly filled undertaking (Form 9)
Assurance from the manufacturer regarding product quality and compliance.
4. Copy of Manufacturing License
Copy of manufacturing license issued in the country of origin.
5. Good Manufacturing Practices Certificate (GMP)
Formal documentation issued by the regulatory authority in the manufacturer’s country.
6. Free Sale Certificate (FSC) / Certificate of Pharmaceutical Product (COPP)
Indicates that the drug was sold and approved for sale in the country of origin.
7. Drug Master File (DMF) / Site Master File (SMF)
Required to provide detailed manufacturing, quality control, and safety information.
8. Product Labels and Package Inserts
In English, and complying with Indian labelling regulations in terms of content.
9. Product Information Sheet (PIS)
Overview with information related to indications, dosage, side effects, etc. of the drug.
10. Stability Study Data
Especially important for drug products that are temperature-sensitive or humidity-sensitive.
11. Testing Protocols and Specifications
Standards under which the drug will be evaluated.
12. List of Countries in Which the Drug is Marketed or Registered
13. Safety and Efficacy Data (if applicable)
14. Proof of payment of fee (TR6 Challan)
Paid according to fees as prescribed in CDSCO's notification and format.
Form 10/10-A requirements for Drug Import License
1. Application Forms (Form 8 or 8-A)
Form 8 for Non-Schedule X drugs
Form 8-A for Schedule X drugs
2. Copy of Import Registration Certificate (Form 41)
3. Covering Letter in
which the purpose of the application and the documentation are explained.
4. Wholesale License (Form 20B/21B)
Of an Indian importer or authorised agent.
5. Product Approval from CDSCO (if earlier approved)
6. Label Samples
By Indian packaging rules.
7. TR6 Challan for Import License Fees.
Additional Documents (if requested by CDSCO)
• Clinical trial data, if any (for new drugs)
• Notarised or apostilled documents (based on the source country)
• Environmental clearance (for some APIS)
Procedure to Obtain CDSCO Drugs Import License
Step 1: Appointment of an Authorised Indian Agent (if required)
If the applicant is a foreign manufacturer, they need to appoint an Indian agent or subsidiary who:
Has a valid wholesale license (Form 20B/21B)
Is authorised through a Power of Attorney
Step 2: Log in to the SUGAM Portal
Go to: https://cdsco.gov.in
Register as a "Foreign Manufacturer" or "Indian Agent/Importer"
Upload KYC and organisation information
Step 3: Import Registration Certificate (Form 41)
Submit using Form 40 (via SUGAM portal):
Submit documents required (FSC, GMP, COPP, DMF, labels, etc.)
Pay the fee applicable (via TR6 Challan)
CDSCO might also raise queries or requests for clarification
After that, CDSCO grants a Registration Certificate (Form 41)
Timeline: Usually takes 2–4 months (if there are no issues with documents)
Step 4: Submit Application for Drug Import License (Form 10 or Form 10-A). Application form:
Form 8 – for non-Schedule X drugs
Form 8-A – for Schedule X drugs
Attach:
Copy of Form 41 (Import Registration Certificate)
Copy of product labels
Copy of wholesale license (Form 20B/21B)
TR6 Challan for import license fee
CDSCO examines the application. If content, it issues:
Form 10 – for general drugs
Form 10-A – for Schedule X drugs
Step 5: Post-Approval Compliance
Once you have the import license:
Ensure labelling, packaging, and distribution norms compliance
Keep records of imports, sales, and stock
Be prepared for CDSCO audits or inspections
Prohibition of the import of certain drugs
Legal Basis
Drugs and Cosmetics Act, 1940, Section 10: Forbids the import of some types of drugs.
Drugs and Cosmetics Rules, 1945, Rule 43: Enumerates certain instances where import is prohibited or prohibited.
Drugs Banned for Import
1. Drugs Not of Standard Quality
• Drugs that do not meet specified quality levels or pharmacopoeial standards.
2. Adulterated Drugs
Contaminated drugs or drugs prepared in insanitary conditions.
Comprises products containing toxic, harmful, or foreign material.
3. Spurious Drugs
Drugs that:
Are falsely labelled or misbranded
Duplicate another product or brand misleadingly
4. Drugs with No or Harmful Therapeutic Value
• If the drug is found to be unsafe or ineffective by CDSCthe O, or the Ministry of Health, its import can be restricted or prohibited.
5. Drugs Banned in the Country of Origin
• If the drug is prohibited in its country of manufacture for reasons of safety, its importation into India is not allowed as a rule.
6. New Drugs Without CDSCO Clearance
• Importing a new drug (not cleared for use in India) without carrying out clinical trials and without prior approval from the CDSCO is forbidden.
7. Schedule X Drugs Without Special Permit
• Narcotics and psychotropic drugs listed under Schedule X need a special permit and are strictly regulated.
8. Biologicals or Vaccines Without Test of Protocol
• Biological products such as vaccines have to be tested at central drug testing laboratories (e.g., CDL, Kasauli) before release for sale.
Examples of Restricted (Banned) Drugs (Indicative List)
Phenacetin – prohibited due to nephrotoxicity
Rofecoxib – withdrawn worldwide because of cardiovascular effects
Sibutramine – prohibited due to cardiovascular side effects
Fixed Dose Combinations (FDCs) – Some irrational FDCs are prohibited
The list is subject to revision according to CDSCO and Ministry of Health updates. Always cross-check with current official notifications.
Penalties for Violations
Importing banned drugs can lead to:
Seizure and destruction of consignment
Fines and imprisonment according to Sections 13 & 14 of the Act
Cancellation of license
Why eStartIndia for CDSCO Drugs Import License?
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