Regulation/Guidelines

CDSCO Releases Frequently Asked Questions on Import and Registration of Drugs in India

  • 7th November, 2019
CDSCO Releases Frequently Asked Questions on Import and Registration of Drugs in India

 

The Central Authority, Central Drugs Standard Control Organisation (CDSCO) came out with Frequently Asked Questions (FAQs) on the Import and Registration of Drugs in India. Let’s take a look at the FAQs:

  1. How is drug import regulated in India?

Chapter III of Drugs and Cosmetic Act, 1940, and Part IV of Drug and Cosmetic Rules provide regulations related to the import of drugs in India.

  1. Which division of CDSCO looks after the registration/import of drugs for human use in India?

Import and Registration Division, Central Drugs Standard Control organisation(CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhawan, ITO, Kotla Road, New Delhi-110002 looks after the registration/import of drugs in India.

  1. Which division of CDSCO looks after the registration/import of drugs for veterinary use in India?

Veterinary Cell, Central Drugs Standard Control organisation (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, FDA Bhawan, ITO, Kotla Road, New Delhi-110002 looks after the registration/import of drugs in India.

  1. What is a Registration Certificate?

Registration Certificate is a certificate issued under Rule 27A of Drugs and Cosmetics Rules, 1945 by the Licensing Authority in Form 41 for registration of premises and the drugs manufactured by the manufacturer meant for import into and use in India.

  1. What is an Import license?

Import License is either a license in Form 10 to import of drugs excluding those specified in Schedule X, or a license in Form 10-A to import of drugs specified in Schedule X.

  1. Who is a “Manufacturer” according to the regulations?

As per regulations, a Manufacturer means a manufacturer of drugs which is either a company or a unit or a body or a corporate or any other establishments in the country (other than India) and have drug manufacturing facilities duly approved by the National Regulatory Authority of the concerned country. They have their free sale approval of the drugs approved by NRA in that country and any other major countries.

  1. What are the requisites for the Import of Drugs in India?

Import of Drugs for commercial use in India require Registration Certificate in Form 41 and Import License in Form 10 as per the Drugs and Cosmetics Act, 1940.

  1. What is the process of getting the Registration Certificate?

Application for Registration Certificate to the Licensing Authority is made in Form 40. According to the rules, this is done by either a manufacturer having a valid wholesale license for sale or distribution of drugs or by the authorised agent in India having valid wholesale license. It needs to be submitted along with fees specified in sub-rule (3) of rule 24 A of the Drugs and Cosmetics Rules 1945 along with the information and undertakings specified in Schedule D- I and D-II duly signed by or behalf of the manufacturer. The applicant submits an application as per the checklist available at https:cdscoonline.gov.in through SUGAM Online Portal.

  1. Is there any requirement of getting site inspection before the grant of registration certificate in Form 41? What is the amount of fees for visit or inspection of manufacturing premises of drugs?

There is no requirement for inspection before the grant of the registration certificate. In case an inspection is required, then the amount of fees is USD 25,000.

  1. What is the process of obtaining an Import license?

Application for import license is made in Form 8 to the Licensing Authority for drugs excluding those mentioned in Schedule X and in Form 8A for drugs specified in Schedule X. According to the rules, this is done by either by the manufacturer having a valid wholesale license for sale or distribution of drugs or by the authorised agent in India having a valid wholesale license. It needs to be submitted along with license fees of one thousand rupees for each additional drug and an undertaking in Form 9 duly signed by or on behalf of the manufacturer. The applicant submits an application as per the checklist available at https:cdscoonline.gov.in through SUGAM Online Portal.

  1. For registration/import of more than one drug or class of drugs manufactured by the same manufacturer, whether there is a requirement of a separate registration certificate/import license?

No. A single application is required, and a single registration certificate/license is issued for import of more than one drug or class of drugs manufactured by the same manufacturer. This is applied if the drugs or classes of drugs are manufactured at one factory or more than one factory working jointly as a single manufacturing unit. The second clause is a separate license or registration in respect of the drugs manufactured by each factory that is required if a single manufacturer has two or more factories situated in different locations manufacturing the same or different drugs.

  1. What is the process of registering new additional drugs in an already approved/valid Registration Certificate?

An Importer needs to apply for endorsement in the already present Registration Certificate with all important documents required for the same. This will be on the condition that the additional drug is manufactured at the same manufacturing site mentioned in the Registration Certificate. Payment of USD 5000 is required for each additional drug. The requirements for endorsement of new additional drugs to the valid Registration Certificate remain the same to the fresh Registration Certificate except for Site Registration fees of USD 10000 and Plant Master File.

  1. Is there any requirement of payment of separate fees if more than one site is used for the manufacturing of the product?

Yes. If a product is manufactured at different sites, separate payment of fees with each site related to different activities like manufacturing, primary packaging, batch release, labeling, etc. has to be made. But if the activities are performed in one site then payment of a single fee is required.

  1. What are the requirements of the re-registration of drugs?

The requirements of the re-registration of drugs are the same as fresh registration of the drug.

  1. What is the amount of fees for application of Registration Certificate in Form 40, application for Import license in Form 8?
Sl No. Legal Form Fees
1. Form 40 Registration fees of USD 10000(or its equivalent in Indian rupees) for premises meant for the manufacturing of drugs used for import and use in India.

Registration fees of single drug USD 5000(or its equivalent in Indian rupees) for import and use in India and an additional fee at the rate of USD 5000 for each additional drug.

2. Form 8 INR 10000 for a single drug and an additional fee of INR 1000 for each additional drug.

 

Note: if the primary packaging site, testing site, batch release site are different from the main manufacturing site, payment of an additional fee of USD 10,000 is required to be done.

  1. What is the process of payment of fees?

The payment should be through Non-Tax receipt portal i.e. www.bharatkosh.gov.in with the below details:

Grant Head of Account Description of Non-Tax Receipt Name of DDO
900 0210-04-1040000-00-1 Fees and Fines

(Clinical Trials, Import and Registration, New Drug)

CDSCO(HQ),New Delhi

  1. What is the time period for approval of the Registration Certificate?

The Licensing Authority will grant Registration Certificate in Form 41 within nine months from the date of receipt of an application if all the information and details provided are complete and in order as per provisions of Schedule D- I and D-II.

  1. What is the duration/validity of the Registration Certificate in Form -41 for Import of Drugs in India?

A Registration Certificate is valid for a period of three years from the date of issue if it is not suspended for any reason. A fresh Registration Certificate is made nine months prior to the expiry of the present one and is continued until new orders are passed for the Registration Certificate.

  1. What is the duration/validity of Import license in Form-10 for drugs in India?

An Import License is valid till the validity of the Registration Certificate unless it is suspended. A fresh license is made three months prior to the expiry of the present one and is continued until new orders are passed for the Registration Certificate.

  1. Can we import drugs with valid Import license from any notified ports in India?

Yes.

  1. Is there any requirement of multiple Import licenses for drugs registered under one Registration Certificate by a single Indian agent or Importer if he wants to import drugs from different notified ports?

No. Single license can be issued for import of more than one drug or class of drugs manufactured by the same manufacturer to the importer. Then, Importer can import drugs from any notified ports as per the provisions of the Drugs and Cosmetics Act and Rules.

  1. Can drugs import with valid Import license stocked in any other facilities with a wholesale license other than mentioned in the Import License?

Yes.

  1. What is the time period for Grant of Import License?

The time period for grant of an Import license in Form 10 is forty five days from the date of receipt of an application if all the documents and information provided are proper and in order.

  1. Is it required for the Indian agent/Importer to get approval for Post Approval Change before applying for the renewal of RC?

Yes. The applicant needs to get Post Approval changes before filling for re-registration so that the post approval changes are documented in renewal RC.

  1. In a situation where RC address is applied but yet to be issued and meanwhile there is a change in the constitution of either Manufacturer or Indian agent, or there is change in address of manufacturer whether fresh fees is required for plant registration and product registration?

Yes. The applicant needs to submit the fresh application along with fees.

  1. Can an applicant submit an application for both Registration Certificate (Form 41) and Import license (Form 10)?

The company needs to get RC before applying for an Import License. After the site gets registered, one can apply for an Import license.

  1. Can we make a simultaneous application for new drug approval and registration certificate?

The applicant can file for both New Drug Approval and Registration Certificate in case of a new drug. RC will be issued after New Drug Permission.

  1. Can an applicant file for a Registration Certificate for a product not sold in the country of origin but is registered and marketed in the countries like USA,Japan, Europe, Canada or Australia?

Yes.

  1. What equivalent documents are required if the drug regulatory authority in the country of origin is not giving a free sale certificate for active pharmaceutical ingredients (API)/finished formulation?

A duly notarized copy of Certificate of Pharmaceutical Products (COPP) is required to be submitted to the Drug authority in India. The certificate should clearly mention that the drug substance is marketed in the exporting country from any other country.

  1. What is the equivalent certificate if GMP certificate for API as per WHO GMP is not available?

Preferably, one should submit a GMP certificate. However, written document of the active ingredients exported to the European Union given by National Regulatory Authority of the country of origin or a duly notarized copy of the certificate equivalent to the GMP certificate as per WHO GMP guidelines issued by the United States of America or Japan or Australia or Canada or European Union for marketing of drug is essential.

  1. Is apostilled POA accepted in place power of attorney executed and authenticated either in India in front of First Class Magistrate, or in the country of origin before an equivalent authority, the certificate of which is attested by the Indian?

Yes, apostilled POA is accepted.

  1. Can we get an Import license without Registration Certificate?

In situations of emergencies, the Licensing Authority can issue Import license in Form 10 or 10A with the approval of the Central Government as per Sub-rule (2) of rule 24. As the case may be without the issuance of Registration Certificate under rule 27(A) and the reasons to be documented in writing.

  1. Is there any requirement of Registration Certificate/Import license for inactive bulk substance used for formulation of drug, with or without pharmacopoeia conformity?

According to the Drug and Cosmetics Rules, Registration Certificate/Import license is not required for inactive bulk substance used for the formulation of the drug, with or without pharmacopoeia conformity.

  1. Is it considered as a change in the constitution of the company if there is a merger or acquisition of registered manufacturer by another company?

Yes.

  1. Is approval of the Licensing Authority required if there is any change in Indian Agent?

Yes. Indian Agent need to inform the licensing authority if there is any change in post approval change applications under SUGAM and get Post Approval Change.

  1. What is Form 9?

Form 9 is an undertaking to accompany an application for an import license given by Manufacturer/Indian Agent.

  1. What are the standards of labelling for the Import of Drugs?

No drug should be imported unless it is packed and labelled in conformity with Parts IX and X of Drugs and Cosmetics Rules, 1945 as per Rule 32 of Drugs and Cosmetics Rules.

  1. What are the addresses on the labels of the registered drugs that are imported/marketed in India as per the Drugs and Cosmetics Act, 1940?

The Name and Address of Legal Manufacturer or Actual Manufacturer and Importer as defined in Form 10.

  1. Is there any requirement of the registration certificate and import license required for the drug transit through India to foreign countries that are not sold or distributed in India?

Registration Certificate and Import License are not required for the drug transit through India to foreign countries that are not sold or distributed in India.

  1. What standards do imported drugs need to comply?

Imported drugs need to comply with standards under the second schedule of the Drugs and Cosmetics Act, 1940.

  1. What are the standards that need to be compiled for the drugs not included in the Indian Pharmacopoeia but are included in the official pharmacopeia of any other country?

Standards like the identity, purity and specified strength of the drug designated in each edition of the official Pharmacopoeia of any other country.

In the situations where identity, purity and strength are not specified in such official Pharmacopoeia but are specified in the edition immediately preceding it then it can be taken as reference.

  1. Is it necessary to mention I.P on the label of Imported Drug?

Yes. The letters I.P. and recognized abbreviations of Pharmacopoeia and the official comendis of drug standards under the Rules need to be mentioned on the label of the drug. This will indicate that the drug is following standards of the Indian Pharmacopeia or any such Pharmacopeia or official compendium of drug standards as per Rules.

  1. What are the different categories of post-approval changes?

The different categories of post approval changes are available under https://cdscoonline.gov.in/CDSCO/Industry.

  1. Can we file a post-approval under RC number X along with approval for RC renewal/ endorsement in the same RC no. X?

It is better to get an approval of post-approval amendment before applying for RC renewal/ endorsement, otherwise the post-approval will not be visible in the renewed RC/endorsement.

  1. What is the meaning of non-medical use?

According to Schedule D of the Drugs and Cosmetics Act, 1945:

  • If the substance is imported in bulk the importer should certify it not for medicinal use
  • If not imported in bulk then each container should carry a label not intended for medical use

Due permission needs to be taken from the Licensing Authority according to the clause(b) of Rule 21 for import of a substance for non-medicinal use without registration and import license.

  1. Where should an applicant approach for getting dual-use NOC?

An Applicant can approach zonal offices of CDSCO for getting dual-use NOC.

  1. Is there any requirement of RC for imported drugs not intended for medical use?

No there is no requirement of RC in this case as Rule 43 of Drugs and Cosmetics Rules 1945 has exempted them from provisions of the Chapter III of the Act subject to the conditions specified in Schedule D.

  1. Is there any requirement of Registration Certificate/Import license for intermediates like 6-AminoPenicillinic Acid (6- APA) having no therapeutic value?

There is no requirement for Registration Certificate/Import License as per the Drug and Cosmetics Rules, 1945 for products like 6-APA, an intermediate of manufacturing for amoxicillin trihydrate.

  1. What is the procedure of importing drugs under Charity purposes in India?

Import of drugs free of cost for charitable hospitals stating that small amount of drugs received in donation by charitable hospital for the purpose of the treatment of the patients in the said hospital may be imported provided the drugs are given or administered free of cost as per Rule 36A of the Drugs and Cosmetics Act,1945.

Drugs shall not be prohibited for import and permitted to be marketed in the country with a residual shelf life of one or more years.

  1. Can Unapproved/Banned drugs be imported for the purpose of charity?

No.

  1. What is the procedure of import of drugs with shelf life less than 60%?

According to Rule-31 of Drugs and Cosmetics Rules, 1945, No drug shall be imported if it does not comply with the standards of strength, purity and quality. The Licensing Authority should not allow the import of any drug having shelf life less than 60% from the date of import. Sometimes, import is allowed having drug less than 60% before the date of expiry declared in the container in exceptional cases if written document is submitted to the Licensing Authority.

  1. According to Government of India, what is the provision for import of drugs for manufacture and export by manufacturing units located at Special Economic zones?

According to the Schedule D of Drugs and Cosmetics Act, 1945, import of drugs for manufacture and export by units located in “Special Economic Zones” as notified by the Government of India are exempted from the provisions of Chapter III of the Act and Rules, it should be covered by import license, import registration and import through notified port of the country. The conditions here are the drugs cannot be diverted for sale in the country.

  1. What is the process of getting approval for change in the name of Indian Agent?
  • The firm has to apply for approval of a change in the name of already registered Indian Agent through SUGAM online portal.
  • Applying to the respective division through SUGAM online portal for fresh RC with a fresh validity
  • Every detail related to changes should be clearly mentioned like NOC obtained in the covering letter for better clarification and transparency.
  1. What is the fee for getting an amendment in the Registration Certificate?

As per G.SR 1193(E) dated 12/12/2018, revised fees in post approval amendment/changes in RC is as:

 Sl No. Type of amendment Fees
1.  Change in foreign manufacturer address in RC(no location change)  USD 1800
2.  Change of Shelf-life in RC(Extension)  USD 1800
3.  Change of Shelf-life in RC(Reduction)  USD 1800
4.  Change in address of registered manufacturer in RC(No   location change)  USD 1800
5.  Change in the manufacturing process or in   packing/labeling/testing/testing/documentation of any drug regarding RC(Minor/Major)  No fee is required for a minor change. But   the fee of USD 5000 per product is required   for major change/modification in   manufacturing process or in   packing/labelling/testing/documentation as   the case may be discretion of the Licensing   Authority.
6.  Change of the name of the manufacturer in RC without   constitution change  USD 1800
7.  Change of Pharmacopoeial specification in RC  USD 1800
8.  Change of Pharmacopoeial specification of drug ingredients   in FF in RC  USD 1800
9.  Deletion of the site involved in the manufacturing of drugs  USD 1800

Note:

(a)Foreign manufacturer means the manufacturing site which is to be registered in the Registration Certificate.

(b)Registered manufacturer means the address of the firm used for communication purposes like the corporate office address or it can be same as that of the foreign manufacturer.

  1. What are the cases where a fresh Registration Certificate required under the provisions of the Drugs and Cosmetics Rules?

According to condition no.6 of RC in Form 41 under the rules of the Drug and Cosmetics Rules “the manufacturer or his authorised agent in India shall inform the Licensing Authority immediately in written document in the case of any change in constitution of the firm and address of the registered office/factory premises operating under this RC. In this circumstance, RC will be valid for maximum period of three months from the date of the change. In the meanwhile, a fresh RC is made with the change in constitution or change in address of the registered office or factory premises”.

According to the rules of the Drug and Cosmetics Act, 1940 Companies need to get fresh RC in the following situations:

  • Change in the name of a foreign manufacturer or registered manufacturer in RC with constitution change.
  • Change of Indian Agent in RC with constitution change
  • Change in foreign manufacturer address in RC with location change.
  • Change in address of Indian Agent in RC with location change.
  • Change in address of registered manufacturer in RC location change
  • Change in constitution of manufacturer
  1. What is the process for getting Registration Certificate for change in Indian Agent with constitution and change in address?

The Manufacturer or Indian Agent needs to immediately inform the Licensing Authority in writing in the event of any change in the constitution of the firm or change in address of the registered office under which RC is taken. If any change is there then current RC is deemed for three months from the date of change. Otherwise, a fresh RC can be made during his time.

  1. What are the cases of Registration Certificate in which payment of fees are required?

As per GSR 1193, Cases of Registration Certificate where payment of fees USD 1800 are required

  • Amendment in Pharmacopoeial status
  • Amendment in shelf life, sale pack(presentation),storage condition, deletion of site
  • Amendment in change in address of registered manufacturer in RC(No location change)
  • Amendment in change in name of the manufacturer in RC without constitution change
  • Amendment in change of Pharmacopoeial specification in RC, change of Pharmacopoeial specification of drug ingredients in FF in RC, Deletion of the site involved in manufacturing of drugs, replacement/addition/deletion of source of dilutant like water for injection, etc.
  1. What are the cases of Registration Certificate where there is no payment of a fee?

Below mentioned cases are considered minor change and fees are not required:

  • Change in batch size of the finished product
  • Tightening of test limits to existing tests
  • Inclusion of warnings in package inserts or any editorial changes
  • Changes in sources of the excipients/API in the finished product
  1. What are the cases of major changes/modifications in manufacturing, processing, testing, documentation where there is a payment of fee of USD 5000?
Sl No. Change Example
1.  Change/modification in manufacturing process  i)  The manufacturer was manufacturing the dosage of   the tablet form with wet granulation method. Presently,   the process of manufacturing is modified to direct   compression method.

ii)  Modification in packaging/packing system like   change in packaging from Aluminium foil to Alu-Alu,   etc.

iii)  Change in liquid form of injection to lyophilized   form, etc.

2.  Change/modification in testing  i)   Initially testing is conducted by the HPLC method.   Later on changed to Gas   Chromatography/Microbiological method, etc.
3.  Change/modification in documentation  i)  Change in indication of the drug or addition of   indication to the existing approved indication.

 

Note: All the changes need to be approved in the country of origin and if the drug is new Form 45 is required.

  1. What is ICEGATE?

ICEGATE stands for Indian Customs Electronic Commerce/Electronic Data Interchange (EC/EDI) Gateway. It is a portal that provides e-filling services to the trade and cargo carriers and clients of Customs department (collectively called Trading Partner).

  1. What is e-SANCHIT?

e-SANCHIT is a e-storage and Computerized Handling of Indirect Tax Documents for paperless processing, uploading of related documents that will facilitate trading across borders.

 

  1. Who can login into e-SANCHIT?

ICEGATE registered users can use e-SANCHIT by e-sanchit link.

  1. What are IRN and DRN?

IRN is Image Reference Number which is unique to each document. DRN is Document Reference Number which is unique to a batch of uploaded documents. A group of IRN is entered to the Bill of Entry and not DRN.

  1. What is the process of obtaining Registration Certificate if its validity expires?

Applicant needs to apply for a fresh Registration Certificate if validity expires as per the check list given in https://cdscoonline.gov.in/CDSCO/Industry.

  1. Is there any requirement of AERB approval for import of radiopharmaceuticals?

Import of radiopharmaceuticals requires submission of No Objection Certificate (NOC) by Atomic Energy Regulatory Board (AERB).

  1. Does the time period calculated by CDSCO include the time required by the applicant to reply to queries?

Timeline is started from the date of submission of application at CDSCO. It does not include the time period taken by the applicant to reply to queries and clarifications.

Time period starts from the date of submission of application at CDSCO. It does not include the time required by the applicant to reply to the queries.

You can send your feedback and suggestions to CDSCO at import.regist@cdsco.nic.in within 7 days from the release of the draft notification.