The import of drugs and cosmetics into India is regulated by the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. The Central Drugs Standard Control Organization (CDSCO) is the primary authority overseeing the approval and regulation of these imports.
The objective is to ensure that imported drugs and cosmetics meet the prescribed safety, efficacy, and quality standards to protect public health.
Regulatory Authority
The import of drugs and cosmetics is regulated by:
- Ministry of Health and Family Welfare
- Central Drugs Standard Control Organization (CDSCO)
- Drugs Controller General of India (DCGI)
Prohibition on the Import of Certain Drugs or Cosmetics
The Drugs and Cosmetics Act restricts the import of:
- Drugs or cosmetics of substandard quality.
- Any misbranded or spurious cosmetic.
- Any adulterated or spurious drug.
- Any patent or proprietary medicine with no description of the formula or list of active ingredients included in it, along with the quantities thereof.
- Any drug which purports or claims to cure or mitigate any such disease or ailment in the form of a statement, design, or device accompanying it.
- Any cosmetic includes an ingredient that may render it unsafe or harmful for consumption.
- Drugs or cosmetics are prohibited from import under these provisions.
The above rules don’t apply to the import of any drugs in smaller proportions for examination, test/analysis, or personal use (subject to conditions).
The Central's Governments Power in Prohibition
The Central Government may prohibit the import of a drug or cosmetic if it is satisfied that:
- Using such a drug or cosmetic involves any risk to human beings or animals.
- The drug lacks the therapeutic value claimed for it.
- The drug or cosmetic includes ingredients in such quantity that there is no therapeutic justification. Such a directive could be passed through a notification in the Official Gazette.
Sea Customs and the Role of Customs Officers
Section 18 of the Sea Customs Act 1878 prohibits the import of sea customs of certain goods, including that certain drugs and cosmetics. Therefore, the Commissioner of Customs or any officer of the Government authorized by the Central Government on this behalf may detain any imported package on the suspicion that the particular container consists of any of such imports. The confiscated drugs or cosmetics will then be taken to the Central Drugs Laboratory.
Licenses Required for Import of Drugs and Cosmetics
| Type of Import | License Required | Issuing Authority |
|---|
| Drugs (Finished/Raw) | Import License (Form 10) | CDSCO |
| Cosmetics | Cosmetic Import Registration Certificate | CDSCO |
| Biological Products | Import License (Form 10) | CDSCO |
| Medical Devices | Import License (Form MD-15) | CDSCO |
Procedure for Import of Drugs
Step 1: Application for Import License (Form 8/8A)
- The importer must apply to CDSCO in Form 8/8A for an import license to bring drugs into India.
Step 2: Submission of Documents
Documents required:
- Covering letter
- Form 8/8A
- Power of Attorney
- Manufacturing License from the country of origin
- Product Information (including testing protocols)
- Certificate of Analysis
Step 3: Inspection and Approval
The CDSCO will inspect the documentation and the manufacturing facility (if required). Once approved, the license will be issued.
Procedure for Import of Cosmetics
Step 1: Application for Cosmetic Registration Certificate
- Importers must apply to the CDSCO in Form 42 to register the cosmetic products for import.
Step 2: Submission of Documents
Documents required:
- Form 42 Application
- Duly authenticated Power of Attorney
- Free Sale Certificate from the country of origin
- Labeling Information
- Product Specification and Test Reports
Step 3: Approval and Issuance of Registration Certificate
Upon verification of the submitted documents, the CDSCO issues a Registration Certificate in Form 43.
FAQs
Can an individual import drugs for personal use?
Yes, individuals can import drugs for personal use, but prior approval from the CDSCO is required.
Is registration required for every cosmetic product?
Yes, each cosmetic product to be imported requires a separate Registration Certificate.
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