Import and Registration of Bulk Drugs and Finished Formulations in India
Import and Registration of Bulk Drugs and Finished Formulations in India
For the import of bulk drugs and finished formulations, the manufacturing site and products need to be registered with the Indian drug regulatory agency – Central Drugs Standards Control Organization. This article talks about the procedure to obtain the Import registration certificate and import license for the import of bulk drugs and finished formulations in India.
Governing Rules and Regulations
The Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetic Rules of 1945 regulate the import, manufacturing, sale, and distribution of bulk drugs (Active Pharmaceutical Ingredients) and finished formulations in India. According to this act, the registration certificate and import license are mandatory for importing bulk drugs and finished formulations into India.
The Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India, is the prescribed authority for importing and registering bulk drugs and finished formulations in India. The registration certificate and import license application must be made to the Drugs Controller General (I) at CDSCO.
Fee Structure for Import Registration
The fee structure for the Import and Registration of Bulk Drugs and Finished Formulations is as follows.
Fee for the Manufacturing Unit Registration
The applicant must pay 1500 USD or its equivalent in Indian Currency to register the manufacturing premises.
Fee for the Drug Registration
The applicant needs to pay 1000 USD or its equivalent in Indian currency for registering a single drug and an additional charge of 1000 USD for each other drug in case the manufacturing unit remains the same.
Fee for Visiting the Manufacturing Premises
The applicant is required to pay 5000 USD or its equivalent in Indian currency for inspection or visit to manufacturing premises. (If required).
Fee for Examination Testing and Analysis of drugs
The applicant is liable to pay the price for examination testing and analysis of drugs directly to the testing laboratory approved by the central government in India or abroad.
Fee for a Duplicate Copy of the Registration Certificate
Suppose the original registration certificate is defaced, damaged, or lost. In that case, the applicant must pay an amount of 300 USD equivalent to an Indian rupee to get a duplicate copy of the registration certificate.
Fee Structure for Import License
The applicant needs to pay the license fee of one thousand rupees for a single drug and an additional cost at the rate of one hundred rupees for each other drug
Documents for Registration of Bulk Drugs and Finished Formulations
The applicant is liable to furnish the following documents to obtain the Import Registration Certificate:
- Covering Letter
- The covering letter is an essential part of the import registration application, and the applicant needs to specify the intent of the import.
- Information on the drugs to be imported
- Manufacturer information like address and contact details
- Authorization Letter
- Application Form
- TR6 Challan
- Power of Attorney
- Wholesale License
- Schedule D(I) (Documents for Registration of the manufacturing Premises )
- Schedule D(II) (Documents for Registration of the drugs)
- Free Sale Certificate
- Good Manufacturing Practice Certificate of WHO guideline or Certificate of Pharmaceutical Product (COPP)
- Manufacturing License and Market authorization Certificate
- Establishment License
- Inspection/Audit Report
- An Undertaking from the proprietor of the firm in case of proprietorship firm
- An Undertaking from the board of Directors in case of a Private Limited Company
Documents for Import Certificate
The applicant needs to furnish the bulk drugs and finished formulations registration certificate to obtain the import license.
Validity of Registration Certificate and Import License
The registration certificate and import license will be valid for three years from the date of its issue.
Eligible Person to Apply
The following person can apply for the import registration certificate for the import of bulk drugs and finished formulations in India.
- Foreign manufacturers ‘having a wholesale license for the sale or distribution of drugs in India.
- Local Authorized Agent of the international manufacturer having either manufacturing or sale License
The application procedure is as follows:
The applicant needs to apply for Registration and import to the Drugs Controller General (I) at Central Drugs Standard Control Organization, FDA Bhawan, Near Bal Bhawan, New Delhi. The prescribed format of the application is as follows:Application for issue of Registration Certificate for import of drugs
The applicant needs to furnish the following details to obtain the import registration certificate.
- The authorized signatory name, designation, department, and the complete address of the organization
- The address of manufacturing premises
- The full and correct Name of the Drugs to be imported in India The drug(s) name will be as below:
- The brand name of the drug
- Details of the different pack, pack size of the same brand of drugs
Note: If a single manufacturer has two or more factories situated in different places and manufacturing the same or different bulk drugs, separate import Registration Certificates need to get in respect of the drugs manufactured by each such factory.
The fees need to pay through a prescribed TR 6 Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 and to be credited under the Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees, and Fines.TR 6 Challan
If the manufacture makes the payment directly from the country of origin, the prices can pay through Electronic Clearance System (ECS). The original receipt of the money transfer will treat as an equivalent to the bank TR- challan, subject to the approval by the Bank of Baroda, CDSCO.
Testing of Drugs
For importing the drugs to India, a lab test will carry out, and three batches need to submit to the designated Laboratory for testing for which the applicant needs to pay the fee to the Laboratory as per their norms. The applicant needs to enclose adequate samples for reanalysis purpose from each of the three consecutive batches along with the following specifications
- Method of analyses
- COA tested in the export country’s Laboratory
- Impurity Standard
- Marker compounds
- Reference Standard along with its
- Certificate of Analysis (COA) where ever applicable
On receipt of an application, the licensing authority will issue the Import Registration Certificate within nine months from the date of receipt of application.
Application for Import License
After obtaining the import registration, the applicant can apply for the import license. After verifying the details, the concerned authority will issue the certificate.Application for License to import drugs
Renewal of Import Registration
The application is to be made nine months before the expiry of the registration certificate. The applicant needs to submit the following documents:
- Application form in the prescribed format
- Power of attorney (POA)
- Good manufacturing practice (GMP)
- Certificate of a pharmaceutical product (COPP)
- Registration certificate
- Drug Master File (DMF)
- Sale or manufacturing License of drugs
The following information and undertakings need to be submitted along with the documents as mentioned above:
- If any administrative action taken due to adverse reaction, the manufacturer or his authorized agent in India need to furnish the relevant documents.
- In case of changes in the drug manufacturing process, packaging, labelling, testing, or documentation, the manufacturer or his authorized agent need to submit the relevant agreements.
- If any change in the constitution of the firm, including the name address of the registered factory premises operating, the details also need to be furnished.
- Details of drugs imported in India during the last three years
- Submission of original Regional Certificate issued
More details on Import and Registration of Bulk Drugs and Finished Formulations in India can be accessed below:Import_guidance_doc