Application for import of Notified Diagnostics Kits in India

Module 6

Import Licence for Notified diagnostic kits in India

The following documents are required to be submitted in the following manner and order for issue of the Import Licence in Form-10 of the Notified diagnostic kits for import into India: –

1. Covering Letter – The covering letter is an important part of the application and should clearly specify the intent of the application (whether the application for the Import Licence of the proposed kit is being submitted for the first time or the application is for renewal). The list of documents that are being submitted (Index with page nos.) as well as any other important and relevant information may be provided in the covering letter. The covering letter should be duly signed and stamped by the authorized signatory, indicating the name & designation of the authorized signatory mentioning Email-Id, Fax no. along with the name and address of the firm.

2. An Authorization letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm intimating the name & designation of the person authorized to sign (along with the name and address of the firm) legal documents such as Form 8 and Form 9 etc. on behalf of the firm should be submitted at the time of submission of the application for Import Licence Duly attested photocopies of the Authorization letter may be submitted at the time of submission of subsequent applications.

3. A duly filled Form 8 (Application for license of import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945) as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation of the authorized signatory. Form 8 Performa is available at Annexure – I.

4. A duly filled Form 9 as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the Indian Agent along with name & designation of the authorized signatory or Duly Apostle/Attested by the Indian Embassy in the country of origin, if Signed and stamped by the Manufacturer along with name & designation of the authorized signatory. Form 9 Performa is available at Annexure – II.

5. The Requisite Fee as prescribed in the Drugs & Cosmetics Act & Rules viz. Rs.1000 for one proposed device and Rs.100 for each additional kit to be imported may be submitted at notified branches of Bank of Baroda under the Head of Account ―”0210 – Medical and Public Health, 04 – Public Health, 104 – Fees and Fines” adjustable to Pay and Account Officer, DGHS, New Delhi in the form of a Treasury Challan. Performa for

Treasury Challan (TR 6) is available at Annexure – III. The Receipt in original (TR 6) is required to be submitted along with the application for Import Licence.

In case of any direct payment of fee by the manufacturer in the country of origin, the fee shall be paid through Electronic Clearance System (ECS) from any bank in the Country of Origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the electronic code of the bank in the Head of Account stated above and the original receipt of the said transfer shall be treated as equivalent to the Bank Challan, subject to the approval by the Bank of Baroda that they have received the payment.

6. A duly attested /notarized (in India) and valid copy of Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C issued by the State Drug Licensing Authority.

Or

Duly attested and valid copy of Manufacturing License issued by the State Drug Licensing Authority in case the Indian Manufacturer is importing the kits in bulk form for further processing.

7. A Valid copy of Registration Certificate in Form 41 issued by CDSCO with respect to proposed kit.

8. The required documents as per condition(s) of Registration Certificate in Form 41 issued by the CDSCO. (If Applicable)

9. A copy of the Import license in Form 10 issued by CDSCO with respect to proposed products. (if the application is for Renewal / Endorsement)

NOTES:

  • Name and address of the manufacturer, Name and address of the manufacturing premises, Name and address of the Indian Agent and Name of the Notified diagnostic kit(s) proposed to be imported should correlate with the name mentioned in Form 8 , Form 9, Form-41.
  • For endorsement to an existing license, a copy of existing Form 10 License and its endorsements, if any should be furnished along with the application.
  • Application for fresh import license should be made three months before the expiry of the existing import license. The original Form-10 should be submitted along with application in such cases.
  • In case the same import license number is to be issued, the same should be mentioned in the covering letter.

Annexures

  1. Annexure I – Format for Form 8
  2. Annexure II – Format for Form 9
  3. Annexure III – Format for TR6 Challan

Central Drug Standard Control Organization
Directorate General of Health Services
Office of Drugs Controller General (India)
(Medical Device&Diagnostic Division)

B.2. Checklist for Pre Screening of Applications for Grant of Import License in Form-10 Notified Diagnostic Kits.

Name of the firm: ___________________________________ Date: _______________

TR-6 Challan No:________________Date:_______________Ref: No:_________________

S. No.Administrative/Legal /Technical DocumentsStatus
Please Tick(√ )
Pg. No.Annexure
1.Authorization Letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm intimating the name and designation of the person authorized to sign (along with the name and address of the firm) legal documents such as Form 8, Form 9 etc.)
2.Form-8 duly Signed & Stamped by applicant along with name & designation of the Authorized Signatory
3.Form-9 duly Signed & Stamped by Indian Agent along with name & designation of the Authorized Signatory or duly, if signed & stamped by the Manufacturer
4.Notarized & copy of Wholesale Licence or Manufacturing Licence of the Indian Agent
5.Requisite Fee Rs.1000 for One Proposed Device and Rs.100 for each additional Device total amount paid
6.Fees paid
Total INR PAID _____________
6.1Head to Fees Deposited (“0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines)
6.2Head to Fees Deposited (“0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines) registered
6.3Realization Stamp
7.Copy of Registration Certificate in Form-41
8.A Copy of import License in Form-10 (if the application is for renewal/ Endorsement)
9.Documents as stated in Registration Certificate (In case of conditional certificate)
10.Labels as per Rule 96 if applicant is other than the Principal Indian Agent
Mailing Address of the applicant : Stamp & Signature of the
Authorised Signatory of the applicant

Mobile No. :……..………………………….

E-mail:………………………………………

Office Use Only:
————————————————————————————————

Accepted for review/Not accepted due to incomplete information in respect of point no. (s) ………………………………………….mentioned above.

Signature: …………………………..

Name of the Reviewer:….……………………….

Date:…………….…………….

Web Link for Download:

Guidance Document on Common Submission Format for Import of Notified Diagnostic Kits in India (IVD’s)
http://www.cdsco.nic.in/writereaddata/Form%20-10%20Doc%20-%20cd.pdf

Pre- Screening Checklist for – Medical Devices and Diagnostics Division Checklist

Feel free to contact us for any query or clarification

Regards
Dr. Manoj Karwa
Head- Clinical Operations
Auriga Research Ltd

Disclaimer: Auriga Research Ltd has tried to arrange content in a simplified manner and accepts no liability for the content. For more updated information, Please visit CDSCO website or link provided above.