Import and Registration of Bulk Drugs and Finished Formulations in India

As per Drugs & Cosmetics Act 1940 and Drugs & Cosmetic Rules 1945, if any substance falling within the definition of a drug (Section 3b of the Act) is required to be registered before import into the country. Not only the drug, but the manufacturing site also needs to be registered for import.

If the drug falls within the definition of New Drug (Rule 122 E of the Act), the new drug approval is the pre-requisite for submission of application for Registration and/or import of drug. The application for Registration and import can be made to the Licensing Authority under the Act i.e. to the Drugs Controller General (I) at CDSCO, FDA Bhawan, Kotla Road, Near Bal Bhawan, New Delhi by the Local Authorized Agent of the foreign manufacturer having either manufacturing or sale License or by the foreign manufacturer having a whole sale License in the country. This is applicable to those drugs manufactured outside India, and the import registration to be issued (under Form 41).

An application shall be made to the Licencing Authority in Form 40, either by the manufacturer himself, having a valid wholesale License, for sale or distribution of drugs or by his authorized agent in India either having a valid License to manufacture for sale of a drug or having a valid wholesale License for sale or distribution of drugs. Form 40 should cover the authorized signatory name, designation, department, along with the complete address of the Company (Manufacturing Site). The drug(s) brand name with different pack, pack size and/or different strengths of the same brand shall be captured. Importer‘s undertaking letter declaring for the information specified in Schedule D (I) (Module 1 of CTD format) and Schedule D (II) (Module 2 to 5 of CTD format), provided by the original manufacturer. The registration Fees amount (Challan number and date) shall be mentioned on Original TR 6 challan having complete name and address of the applicant and details of application to be enclosed. A copy of Whole Sale License of applicant & copy of Authorization letter of Applicant along with power of Attorney issued by the manufacturer should also be submitted.

Fee structure for Import Registration under Form 40

Applicant shall make a payment of 1500 USD (or its equivalent to Indian Currency), as registration fee for the Manufacturing premises. Applicant shall make an payment of 1000 USD (or its equivalent to Indian Currency), as registration fee for a single drug and additional fee of 1000 USD for each additional drug in case the manufacturing site remains the same. Fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110 001 or any other Bank, as notified, from time to time by the authority.

Applicant is liable to pay 5000 USD (or its equivalent to Indian Currency) for Expenditure [Inspection fees + expenditure on inspection to be borne by company] as may be required for Inspection or Visit of manufacturing premises. The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the central government in India or abroad, as required for examination testing and analysis of drugs. Applicant has to pay a fee of 300 USD (or its equivalent to Indian Currency) for a duplicate copy of the registration certificate, if the original is defaced, damaged or lost. Registration time provided further that if the application is complete in all respects and information specified in D (I) & D (II) are in order, the licencing authority shall within 9 months from the date of receipt of application issue such Registration Certificate, and in exceptional circumstances and for the reasons to be recorded in writing, the Registration Certificate may be issued within such extended period not exceeding 3 months as the licencing authority may deemed fit.

Label submission:

  • True copy of label as approved in the country of origin
  • True copy of label as per Rule 96 of the Act. If the drugs is in IP label claim must be as per IP.
  • In case monograph does not exist in current IP, however was included in the earlier version, then IP monograph of the earlier version is to be followed instead of USP or BP. Testing of drugs – In case of registration of Bulk (Active Pharmaceutical Ingredient) drugs the consecutive three batches are asked to be submitted to the designated laboratory for testing for which fee is to be paid by the applicant to the Laboratory as per their norms.

The applicant should enclosed samples sufficient for three analyses from each of the three consecutive batches along with specifications, Method of analyses, COA tested in their laboratory, impurity Standards, marker compounds, Reference Standard along with its COA where ever applicable

Duly notarized/ Apostilled/ Attested (by Indian Embassy the country of origin) and valid copy following documents is required at time of application.

  • Free Sale Certificate/ Certificate to Foreign Government/ Certificate of Marketability/ for each drug issued by the National Drug Regulatory Authority of the country of origin. Free Sale Certificate should state that the proposed drug is freely sold in Country of Origin and can be legally exported
  • GMP Certificate of WHO guideline or Certificate of Pharmaceutical Product (COPP) as per WHO GMP Certification Scheme/ Product Registration Certificate issued by NRA and or proof of DMF approval by NRA and/or CEP (EDQM certificate) for each drug issued by the National Drug Regulatory Authority of the country of origin
  • Manufacturing License and or Market Authorization Certificate in respect of applied drugs issued by the National Drug Regulatory Authority of the country of origin). Free sale certificate of other countries if available is also be submitted
  • Establishment License (in respect of the foreign manufacturing sites)

Copy of Inspection/ Audit Report latest carried out by National Regulatory Authority country of origin or other regulatory authorities like USFDA, MHRA, EU, and TGA. Number of countries where it is approved (should be a part of Plant Master File).

If the drug is new drug, application for registration is to be made only after obtaining approval on Form 45 (as applicable). In case, the item considered as drug as per the definition of section 3 (b) of the Act in India but not registered as drug in the country of origin a legal undertaking from the manufacturer and approval of the item from the competent authority of the country of origin duly notarized and apostled should be submitted. The application of r-DNA products should be made separately as per the guidance document for submissions for biological. In case of bulk drug, if the same is approved in EU/USA etc. DMF approval number may mention on the covering letter itself.

Renewal of registration or re-registration

At the time of application for renewal of registration or re-registration, the application is to be made 9 months before the expiry of the Registration Certificate. In addition regulatory documentary compliance like Form 40, POA, GMP/ COPP, Registration certificate, Plant Master File (soft copy, if no change), DMF (soft copy, if no change), License (sale or manufacturing License of drugs of the agent) etc., the following undertaking/ information is to be submitted:

  • Undertakings by the manufacturer or his authorized agent in India in respect of any administrative action taken due to adverse reaction, viz. market withdrawal, regulatory restrictions, or cancellation of authorization, and/or not of standard quality report of any drug pertaining to this Registration Certificate declared by the Regulatory Authority of the country of origin or by any Regulatory Authority of any other country, where the drug is marketed/sold or distributed
  • Undertaking by the manufacturer or his authorized agent in India in respect of any change in manufacturing process, or in packaging, or in labelling or in testing, or in documentation of any of the drug pertaining to this Registration Certificate
  • Undertaking by the manufacturer or his authorized agent in India in respect of any change in the constitution of the firm including name and/or address of the registered office/ factory premises operating under this Registration Certificate
  • Details of drugs imported in India during last three years
  • Details of sampling of drugs in India and results thereof
  • Submission of original RC issued
  • Annual product Review of registered drugs (last three years)

Format for Import License in Form 10 of Bulk Drug(s) and Finished Formulation(s) in India

  1. Covering Letter
  2. An Authorization letter
  3. Form 8
  4. Form 9
  5. Requisite Fee- Rs.1000 for 1 proposed Drug and Rs.100 for each additional Drug to be imported
  6. A duly attested (by gazetted officer)/notarized (in India) and valid copy of wholesale License for sale or distribution of drugs or manufacturing License (should be enclosed with the product permission list), under Drugs and Cosmetics Rules issued by the State Licensing Authority
  7. A Valid copy of Registration Certificate in Form 41 issued by CDSCO with respect to proposed Drug, duly authenticated by Indian Agent
  8. Original Import License in Form 10 issued by CDSCO with respect to proposed Drug (If the application is for renewal)
  9. The required documents as per Registration Certificate in Form 41 issued by the CDSCO (If Applicable)