Application for Import Licence of Non-notified diagnostic kits

Module 7

Import of non-notified diagnostic kit(s) in India

The following documents are required to be submitted in the following manner and order for issue of the Import Licence of Non-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 or the application is for endorsement). 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 the Email-Id, Fax 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 revealing 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. It should have validity period as per company’s policies. 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 indicating the Generic name and Brand name (if any) and specific intended use as mentioned in package insert in not more than 40 words for each proposed product. If the firm intends to import product in Bulk it should be mentioned in Form 8 product list wherever applicable. Form 8 Performa is enclosed at Annexure – I.

4. A duly Apostiled/Attested by Indian Embassy in the country of origin Form 9 as per the Performa prescribed in the Drugs & Cosmetics Rules, signed & stamped by the manufacturer along with name & designation of the authorized signatory indicating the Generic name and Brand name (if any) and specific intended use as mentioned in package insert in not more than 40 words for each proposed product. If the firm intends to import product in bulk it should be mentioned in Form 9 product list wherever applicable. Form 9 Performa is enclosed at Annexure – II.

5. The Requisite Fee as prescribed in the Drugs & Cosmetics Act & Rules viz Rs. 1000 for One proposed kit 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 annexed 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. Applicant is required to submit separate fee for each of the categories like test strip, cassettes, midstream, etc which the firm intent to import/Register.

6. Duly notarized/Apostilled/Attested (by Indian Embassy in the country of origin) and valid copy of Free Sale Certificate/Certificate to Foreign Government/ Certificate of Marketability for each kit issued by National Regulatory Authority of the country of origin clearly stating that the proposed Kits/Reagents are freely sold in the country of origin and can be legally exported. It should also specify name and address of legal and actual manufacturing site along with applied product name(s) Generic name and Brand name (if any)

or

If the proposed products are not sold freely in the country of origin, Free Sale Certificate from National Regulatory Authority of other countries where the proposed products are being freely sold.

7. A duly attested (by gazetted officer)/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.

8. A Valid copy of ISO 13485 Certificate Apostilled/notarized/Attested from the Indian embassy (country of origin) reflecting the name and the address of the manufacturing site.

9. Performance Evaluation Reports (Not test reports) conducted by National laboratory or accredited Laboratory in India for three consecutive batches of the products intended for TB, Dengue, Malaria, Chikunguniya, Typhoid, Syphilis and Cancer. A copy of valid NABL certificate in respect of lab where in Performance evaluation was carried out.

10. Product Inserts (English version or Authenticated translated copy) and published articles (if any) for each Diagnostic kits/ Reagents proposed to be imported mentioning sensitivity and specificity wherever applicable.

11. Certificate of Analysis issued by the manufacturer in respect of the proposed products mentioning sensitivity and specificity wherever applicable.

12. Original Coloured Labels as per Rule 96 of Drugs and Cosmetic Act and Rules and pack size in respect of the proposed products.

13. Soft copy of product list along with specific intended use as mentioned in the package insert in not more than 40 words

14. For veterinary IVD Kits NOC from Department of Animal Husbandry, Ministry of Agriculture, Krishi Bhavan, New Delhi is required.

15. For Radio Immuno Assay Kits NOC from Bhabha Atomic Research Centre, Mumbai is required.

16. NOC from DG, ICMR, New Delhi for the product intended for influenza

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 non- notified diagnostic kit(s) proposed to be imported should correlate with the name mentioned in Form 8 , Form 9, FSC
  • 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.
  • The copy of Form-10 should be submitted along with application in such cases.

Product related documents like (product insert, COA, Label and Performance Evaluation Report, etc) shall be arranged as per the S.No & order of Form 8 product list

ANNEXURE

  1. ANNEXURE – I FORM 8
  2. ANNEXURE – II FORM 9
  3. ANNEXURE – III TR6 Challan
  4. ANNEXURE – IV Format for correlation chart
  5. ANNEXURE – V Minimum requirements in the Performance Evaluation Report

ANNEXURE – IV

Format for correlation chart

S.NoProduct name
reflected in
Form 8
Position in
Form 8
(Page & S.No)
Position in
Form 9
(Page & S.No)
Position in FSC
(Page & S.No)
(example)
1
EBV RT-PCR kitPage 1, S.No 01Page 1, S.No 1Page 4, S.No 36

ANNEXURE – V

Minimum requirements in the Performance Evaluation Reports

Typically a Performance Evaluation Report should mention following details: Product name, lot / batch number, manufacturer name, importer name, import / Test licenses number, number of samples tested, testing principle (ELISA/Rapid/NAAT,etc.,) Testing procedure, Report number, Date of analysis, designation & signature of analyst and authorized signatory of the laboratory etc.

Information about reference product / method used, Specificity, Sensitivity, Positive predictive value, Negative predictive value (wherever applicable) should be mentioned.

The sample size should be statistically significant to establish/demonstrate the clinical sensitivity & specificity of the proposed kits/reagents in Indian population.

B.4. Checklist for Pre-screening of Applications for Grant of Import license in Form 10 for Non-Notified in-vitro diagnostic Kits/reagents:

Name of the firm: ___________________________________ Date: _______________

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

S. No.Administrative/Legal /Technical DocumentsStatus
Please Tick(√ )
Pg. No. Annexure
1.Covering Letter-Purpose should be clearly mentioned with page number and Index.
2.Authorization letter in original issued by the Director/Company Secretary/Partner of the Indian Agent firm revealing 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
3.Form-8 and product list along with specific intended uses, duly signed and stamped by the Indian agent along with name and designation of authorized signatory(with full address) indicating the Generic name and Brand name (if any) and specific intended use as mentioned in package insert in not more than 40 words for each proposed product . If the firm intends to import product in Bulk it should be mentioned in Form 8 product list wherever applicable.
4.Duly notarized Form 9 duly signed and stamped by the authorized signatory of manufacturer (with full address) from country of origin indicating the Generic name and Brand name (if any) and specific intended use as mentioned in package insert in not more than 40 words for each proposed product. If the firm intends to import product in Bulk it should be mentioned in Form 9 product list wherever applicable.
5.Requisite Fee Rs.1000/- for one proposed product and Rs. 100/- for each additional product. Applicant is required to submit separate fee for each type of product viz. test strip/cassettes/midstream, etc which the firm intent to import
6.Duly notarized copy of Free Sale Certificate/Certificate to Foreign Government/ Certificate of Marketability issued by National Regulatory Authority from country of origin mentioning name and address of both legal and actual manufacturer.
7.Notarized copy of whole sale license or manufacturing license in respect of Indian Agent/importer
8.Duly notarized, from country of origin, copy of ISO 13485 certificates in respect of Actual manufacturer.
9.ISO/ CE certificates (If any)
10.Original Performance Evaluation Reports (PER) from National
Accredited Labs of India for 3 batches for products intended for Tuberculosis, Dengue, chikungunya, Syphilis, Typhoid and Cancer markers.
11.In case of Malaria Kit, PER from any one of the following Laboratory:
i) NIB, Noida
ii) NVBDCP,New Delhi
iii) NIMR, Delhi
iv) RMRCT,Jabalpur (M.P.)
12.NOC from Department of Animal
Husbandry, Ministry of Agriculture, In
Case of Veterinary IVD Kits
13.NOC from Bhabha Atomic Research Centre(BARC), Mumbai, In case Radio Immuno Assay Kits
14.NOC from DG, ICMR, In case of influenza Kit
15.i) Product inserts,
ii) Labels,
iii) Certificate of analysis(COA) for the proposed products
16.Soft copy of product list along with specific intended uses (Word format)
17.Correlation chart w.r.t. products list mentioned in Form 8, Form 9 and FSC submitted
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 Non-Notified Diagnostic Kits in India (IVD’s)
http://www.cdsco.nic.in/writereaddata/Form-10%20%20Doc%20-%20ncd.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.