Import of drugs in India is Governed through Drugs and Cosmetics Act, 1940 and Rules, 1945 made thereunder. Central Drugs Standard Control Organization (CDSCO) is the Authority responsible for review, processing and grant of registration certificate in India. In the present article we will understand the various aspects of Drug Registration Process for Import in India.

What is the meaning of Import Registration in terms of drugs?

Any overseas manufacturer of the drug (bulk or formulation) who intends to market their products in India, need to get their site as well as product registered in India. The firm has to make an application to the CDSCO through an Indian Agent on an online application portal.

Who is an Indian Agent?

An Indian agent must be a resident of India and his/her firm must be holding drug wholesale license on Form 20-B and 21-B. The Indian agent will act as a local representative of the overseas manufacturer firm and shall hold the Power of Attorney to make an application for grant of Registration Certificate.

What is the process of making an application for grant of Registration Certificate?

The overseas manufacturer shall register themselves on www.cdscoonline.gov.in through its Indian Agent. After registration, the firm shall make an application of Form 40 on online portal. After review, the firm will be granted the Registration Certificate i.e. Form 41.

What are the documents required for making an application for registration certificate?

Documents required for filing an application for registration certificate are as follows:

  1. Covering Letter
  2. Authorization Letter
  3. Form 40
  4. Power of Attorney
  5. Fee
  6. Copy of Wholesale License
  7. Copy of new drug permission on CT-19/ CT-20 as applicable
  8. Documents as per Schedule D (I) and D (II)
  9. Apostilled or Notarized copies of GMP, COPP or FSC (Free Sale Certificate)
  10. Specimen Labels etc

What is Schedule D (I) and what are the documents required to be submitted under Schedule D (I)?

Schedule D (I) enlists the documents related to manufacturing premises which is to be registered as a part of drug registration. If a drug product is manufactured at two plants say, manufacturing at one plant and packing and release at other, then the data of both the sites to be provided. List of documents required to be submitted are as follows:

  1. Notarized Plant Master File
  2. List of major equipment in Production and QC
  3. List of personnels with qualification, experience and responsibilities
  4. Organization Chart
  5. QA functional Chart
  6. Plant Layout
  7. HVAC system drawing
  8. Water system drawing
  9. Pressure differential drawing
  10. Personnel movement drawing
  11. Material movement drawing
  12. Distribution, Complaints & products recall SOP
  13. List of Contract Manufacturing/analysis

What is Schedule D (II) and what are the documents required to be submitted under Schedule D (II)?

Schedule D (II) enlists the documents related to the product which the oversees manufacturer intends to register as a part of drug registration. A manufacturer can apply for one or more products in a single application. List of documents required to be submitted are as follows:

  1. Notarized Drug Master File
  2. Process flow chart
  3. Manufacturing process development report
  4. Control of critical steps
  5. Process validation report of three batches
  6. List of Impurities and related substances
  7. List of Residual solvents and its limits
  8. Testing procedure of impurities, related substances and residual solvents
  9. Source and maintenance of reference standards
  10. Container and closure system and its testing procedure
  11. Batch determination: batch numbering system & batch size
  12. Specification of the products & material used in its manufacturing
  13. Justification of the Specification
  14. Certification of analysis of five batches
  15. Labels and Package insert
  16. MSDS
  17. Details of PMS studies
  18. Stability data

Is there a difference between drug registration for old drug and new drug?

Yes, there is a slight difference. For old drug you can directly make an application on Form 40 for registration. However, in case of new drugs you need to first apply on CT-18 for grant of CT-19 (API/ Bulk) or CT-20 (Formulation) as applicable. After receipt of CT-19 and/or CT-20, you may apply on Form 40 for drug registration.

Click here to read our article for understanding what is a new drug and approval process of new drug in India.

Where to apply for Form 40 i.e. drug registration?

Applications for Form 40 are made on www.cdscoonline.gov.in.

For any support in filing the application you may contact us on vaayath@gmail.com

What is the fee for the application?

Application fee for Form 40 includes following:

For new registration or renewal –

For a single site: 10000 $

For a single product: 5000 $

What is the validity of Registration Certificate?

A registration certificate is valid for 3 years from the date of issuance.

Do you require Registration Certificate for excipients/ inactive bulk?

No, Registration Certificate is not required for excipients/ inactive bulk.

Drug Regulatory Approvals in India with Vaayath

Vaayath is a leading provider of comprehensive pharma regulatory services, serving as a one-stop destination for all your regulatory needs. With a focus on excellence and a commitment to delivering outstanding results, we have quickly carved a niche for ourselves in the industry as trusted regulatory consultants. At Vaayath, we possess a wealth of expertise in a diverse array of regulatory activities. One of our core strengths lies in providing invaluable insights and strategic support to our clients. We work closely with them to understand their unique goals and challenges, enabling us to develop effective strategies that streamline the regulatory pathway. We help in Drug Registration by following ways:

  • Assistance with end-to-end registration processes.
  • Preparation and submission of pharmaceutical dossiers to the CDSCO.
  • Analysis of dossier compliance with CDSCO regulations.
  • Preparation of reports. Plans to address any gaps identified.
  • Help with marketing authorization / New drug applications.
  • Consultation on drug affairs in India.
  • Management of queries and support until approval is granted.
  • Assistance in registering imports.
  • Design and Management of pharmaceutical artwork.
  • On-demand consultation and provides the List of Approved Drugs in India to help the pharma associates.
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