Category: Cdsco import license application status

Cdsco import license application status

cdsco import license application status

Select Location:. Select Year:. Select Year Select Month:. Pendency status of the application which is beyond prescribed time period for the January Import Divsion. Medical Devices and Diagnostics Division Division Pendency status of the application which is beyond prescribed time period for the December month. Pendency status of the application which is beyond prescribed time period for the July month Import divsion.

International Cell Pendency status of the application which is beyond prescribed time period for the May month. International Cell Pendency status of the application which is beyond prescribed time period for the April month.

Pendency status of the application which is beyond prescribed time period for the February month International Cell. Import and Registration Divsion Pendency status of the application which is beyond prescribed time period. Status of the application online received w.

Pendency status of the application which is beyond prescribed time period. Status of the application online received. Pendency status of the application which is beyond prescribed time period for the april Month International Cell.All around the World, Persons are in need of medicines; some of the medicines are manufactured and available to them locally. Remaining need of medicine has to be imported from other countries.

This enhances the trade of the drugs from one place of the world to another. India occupies a third largest position in the world in the field of Pharmaceutical industry. CDSCO regulates the manufacture, sale, import, export, and clinical research of drugs. DRUG: A medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body. In India import of Drugs, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act and Drugs and Cosmetic Rules At present, bulk drug Active Pharmaceutical Ingredients and finished formulations are regulated under the said Act.

Any substance falling within the definition of drug required to be registered before import into the country. Not only drug but the manufacturing site needs to be registered for import of drugs. If the drugs, fall within the definition of New Drug, 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.

No New drugs are allowed to be imported into the country without the sanctioned of the licensing authority in writing. All drugs whose composition is not recognized as safe for the use by experts and which have not been used to any large extent or for any appreciable period of time are to be regarded as new drug. Permission for the import of new drugs may be obtained from the licensing authority after furnishing to him documentary evidence of the standards of quality, Purity and strength of the drug.

The application for import of new drugs including their fixed dose combinations should be accompanied as specified in schedule Y, provided that data on clinical trial for a drug may not be submitted, if the licensing authority decides to grant import permission without it in public interest. Application is made in FORM 44 accompanied with following data in accordance with appendices, namely.

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

Your name:. Your email address:. Send post to email address, comma separated for multiple emails. Import of drugs in India. DRUG: A medicine or other substance which has a physiological effect when ingested or otherwise introduced into the body In India import of Drugs, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act and Drugs and Cosmetic Rules Drug and Cosmetic Act It Contains provisions for classification of drugs under given schedules Guidelines for the storage,sale,display and prescription of each schedule.

Leave a reply Cancel reply You must be logged in to post a comment. Contact Us Now. Designed by Pink Elephant Creatives.Registration Certificate is a certificate issued under Rule 27A of Drugs and Cosmetics Rules, 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.

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

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, 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. 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. 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 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 and Plant Master File. 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.

But if the activities are performed in one site then payment of a single fee is required. Registration fees of single drug USD or its equivalent in Indian rupees for import and use in India and an additional fee at the rate of USD 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, is required to be done.

The payment should be through Non-Tax receipt portal i. 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. A Registration Certificate is valid for a period of three years from the date of issue if it is not suspended for any reason.Nowadays, therapeutic treatment based on medical devices is providing technologically advanced solutions for the management, diagnosis, treatment,mitigation or prevention of several diseases.

Thus, the demand continues to grow in the market at a tremendous rate leading to a renewed interest in the scientific development and research in the field of medical devices. A rise in the manfacture of these devices requires new improvised regulations to prevent the infiltration of improper products into the market.

The Government of India has been making immense changes in the rules governing the sale, manufacture, import and registration of medical devices in India. The aim is to simplify and ease the processes for the same while ensuring the highest standards for safety and performance of medical devices. Finance Minister Mr.

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Arun Jaitley announced that these new guidelines will come into force from 1st January, The new guidelines have come as an extension of the Draft of Medical Devices Rules published in October, The revised rules are meant to set Indian guidelines at par with international standards and have been constructed on the framework of the Global Harmonization Task Force GHTF.

The medical devices are classified into the following 4 categories based on the risk involved in usage. As per a new circular released on Nov 1, even the companion components of medical devices or accompanying peripherals that are used along with them are classified. Notified Bodies are Government accredited third-party authorities that are licensed by the central licensing authority to audit medical devices and inspect manufacturing sites to ensure that they are conforming to the Quality Management System and other applicable protocols prescribed by the Bureau of Indian Standards.

The regulatory duties have been divided between the State and Central Governments based on the class of medical device. Here is a list of all the forms to be filled in for obtaining requisite licenses for medical devices —.

Similar to manufacturers, importers too must fill appropriate forms to obtain a license to import medical devices into India. Here are the forms applicable for importers of medical devices —. Starting 1st January,each medicaldevice, approved for manufacture for sale, distribution or import, must bear a unique device identification number which shallcontain a device identifier numberi.

A: As per the new Medical Devices Rules,there is no expiry date for a license and it is valid in perpetuity after being issued as long as the following criteria are being met:. A: For import of medical devices to India, an application should be made to the Central Licensing Authority through the online portal of the Ministry of Health and Family Welfare via Form MD along with the specified fee.

The application should be made via an authorized agent having licence to manufacture for sale or distribution in India or a wholesale license for distribution or sale in India. If all the documents found appropriate after examination by the Central Licensing Authority. Central Licensing Authority may also inspect the manufacturing site by itself or via a third party.

A: The grant of Import license takes place within 9 months from date of application. In case of rejection, the importer may appeal to the Central Government within 45 days and after sufficient enquiry into the case, the Government may pass orders within 90 days from date of such an appeal. A: Yes.Notified medical devices are regulated by the Central and State Government of India. It is important to have knowledge of the important forms and documents required to commercialize your medical device in India.

The required licenses and permissions are explained in the table below: whether they are governed by the CDSCO or a state authority. Contact us at Morulaa to learn more. Terms By checking this box, you agree to receive newsletter, emails and other materials from Morulaa HealthTech and its affiliates.

Information requested is for Morulaa HealthTech marketing purposes only and will not be sold or shared with a third party. Each email provides a one-click method to unsubscribe from the distribution list. I also confirm that I am at least 18 years of age. Your name:. Your email address:. Send post to email address, comma separated for multiple emails. If your products come under the notified device category then they would have to registered with the CDSCO under form The registration certifcate is valid for 3 years Form 41 Form 40 Rule A DCGI 9 months Import License Once the foreign manufacturer obtains the registration certificate in Form 41, the distributor needs to apply for Import license in form 8.

This license allows the distributor to clear customs and import the product into the country Form 10 Form 8 Rule 24 DCGI No time period prescribed Usually within 3 months Test License for Import Form 11 is granted for the import of small quantities of drugs and medical devices for the purposes of examination testing or analysis.

Products imported under form 11 will used for testing and analysis purpose only and not for any commercial activity Form 11 Form 12 Rule 33 DCGI No time period prescribed Test License for Manufacturing Form 29 is a licence to manufacture drugs for the purpose of Examination Testing and Analysis.

The application is made in Form 30 and the certificate is valid for 1 year. The applicant cannot perform any manufacturing activity other than for examination, testing and analysis purpose in the proposed manufacturing site. The applicant must provide satisfactory post market data, clincal studies conducted worldwide and safety data to obtain the registration certicate for India.

Form 45 Form 44 Rule A DCGI six months Permission to Manufacture Post Successful Clinical Trial A license in form 46 is granted when an application is made in Form 44 under the rule B, to allow manufacturing for sale of medical devices which are new in the Indian market without conducting clinical trials. Form 46 Form 44 Rule B DCGI six months Retail sale of Notified Medical Devices Application for grant or renewal of a restricted licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail by dealers who do not engage the service of a qualified person Form 20, Form 21 for sutures, ligatures, In-vitro diagnostic devices Form 19 Rule 61 1Rule 61 2 for sutures, ligatures, In-vitro diagnostic devices State Drug Licensing Authority No time period prescribed usually between three to six months Whole sale of Notified Medical Devices Application for grant or renewal of a licence to sell, stock, exhibit or offer for sale, or distribute drugs other than those specified in Schedule X who engage the service of a qualified person.

No time period prescribed usually between three to six months Loan License manufacture in facility owned by third party Manufacturing of notified device in a third party site requires a loan license in Form- 25A and Form A.

cdsco import license application status

Contact Us Now. Designed by Pink Elephant Creatives. Your name: Your email address: Send post to email address, comma separated for multiple emails. This is to obtain product approval for Indian market entry. The registration certifcate is valid for 3 years. Once the foreign manufacturer obtains the registration certificate in Form 41, the distributor needs to apply for Import license in form 8. This license allows the distributor to clear customs and import the product into the country.

Form 11 is granted for the import of small quantities of drugs and medical devices for the purposes of examination testing or analysis. Products imported under form 11 will used for testing and analysis purpose only and not for any commercial activity.

Form 29 is a licence to manufacture drugs for the purpose of Examination Testing and Analysis.As per Rule 33 of Drugs and Cosmetics Acts and Rules Form 11 is granted for the import of small quantities of drugs for the purposes of examination testing or analysis.

Form12, T. No, drugs imported under Form11 licence will used for testing and analysis purpose only it will not used for any commercial activity. Excipients, starting material, herbal products and ayurvedic product cannot be granted under Form11 licence however banned drugs can be imported under form11 licence. There is no provision for the renewal of Form 11 licence once it is expired the firm has to apply for fresh form11 licence with challan all other relevant documents.

Yes,for test examination and analysis at other firm premises a notarized agreement between them and manufacturing Licences or DSIR approval of other firm premises has to submit. Home FAQ. Frequently Asked Questions about Test Licence. What is Form 11 Licence? What is the fees required for form 11 licence? What Documents is required for filing the form 11 application? Drugs imported under form11 licence can be used for commercial purpose?

What documents should be attached in case of import of large bulk API? Is Form11 licence is applicable for banned drugs, excipients, startingmaterial, herbal and ayurvedic products? Form11 licence can be renewed or not? How many drugs can be imported under single Form 11 licence? Only 10 drugs can be imported under single Form11 licence.

Is it possible to import narcotic drugs under Form 11 licence for test examination and analysis?

cdsco import license application status

The drugs imported under Form 11 Licence can be used for animal studies? Is it possible to do test examination and analysis at others firm premises? What is blood bank? What is apheresis? Apheresis is the process by which blood drawn from a donor, after separating plasma or platelets, or leucocytes, is re-transfused simultaneously into the said donor. Is the licence required to run a blood bank? Yes, licence is required to run a blood bank.

Application in Form C with required fees Plan of Premises Copies of certificates relating to the educational and experience of the all the technical staff SBTC Approval Documents relating to the ownership andtenancy of the premisesand constitution of the applicant. What is the fee required to open a blood bank? Total Rs. Who all are the competent technical staffs required for a blood bank?

Every blood bank shall have following categories of whole time competent technical staff:- Medical Officer:- Postgraduate degree in Medicine M. T with six months experience in the preparation of blood components; or Diploma in Medical Laboratory Technology M.

T with one years experience in the preparation of blood components. What is FormC?

CDSCO Registration: Wholesale and Manufacturing License

What is Form C? What is Form- 26 G? What do you mean by SBTC?The current regulations has only 23 types of medical devices and IVD require registration and so this regulatory draft represents a significant change to the regulatory requirements for most medical device manufactures selling or intending to sell in India. In-vitro diagnostic products used in-vitro diagnostic procedures shall be assigned to Class A if it is intended to be used as.

Import of drugs in India

In-vitro diagnostic products for detecting transmissible agents shall be assigned to Class D if it is intended to be used. IVD products for blood grouping or tissue typing referred to in sub-clause a shall be assigned to Class D, if it is intended.

The other articles on the Indian medical device rules, o and the classification system followed is below. Terms By checking this box, you agree to receive newsletter, emails and other materials from Morulaa HealthTech and its affiliates. Information requested is for Morulaa HealthTech marketing purposes only and will not be sold or shared with a third party. Each email provides a one-click method to unsubscribe from the distribution list. I also confirm that I am at least 18 years of age.

Your name:. Your email address:. Send post to email address, comma separated for multiple emails. Notes:- If the device is intended to be used in combination with another device then the classification rules shall apply separately to each of the devices. Software which operates a device or influences the use of a device falls automatically in the same class.

Standalone software which are not incorporated into the medical device itself and provide an analysis based on the results from the analyser shall be classified in to the same category that of the IVD where it controls or influences the intended output of a separate IVD. Subject to the clause c and dsoftware that is not incorporated in an IVD shall be classified using the classification provisions as specified in clause 2.

Calibrators intended to be used with a reagent should be treated in the same class as the IVD medical device reagent. Class A In-vitro Diagnostic Medical Devices: In-vitro diagnostic products used in-vitro diagnostic procedures shall be assigned to Class A if it is intended to be used as, a reagent or an article which possesses any specific characteristic that is intended by its product owner to make it suitable for an IVD procedure related to a specific examination an instrument specifically to be used for an IVD procedure or a specimen receptacle.

Important Licenses and Forms to Keep in Mind: CDSCO

Class B In-vitro Diagnostic Medical Devices: IVD products for self-testing referred to in sub-clause a shall be assigned to Class B if it is intended to be used to obtain test results that are not for the determination of a medically critical status or preliminary test results which require confirmation by appropriate laboratory tests. Other IVD products shall be assigned to Class B If clauses 2 i to 2 v do not apply to it or a substance or device used for the analysis of the performance of an analytical procedure or a part thereof without a quantitative or qualitative assigned value.

Determining infective disease status or immune status, where there is a risk that an erroneous result will lead to a patient management decision resulting in an imminent life-threatening situation for the patient being tested. Management of patients suffering from a life-threatening infectious disease. Screening for congenital disorders in the foetus Blood grouping or tissue typing is subject to sub-clause b if it is intended to be used for blood grouping or tissue typing to ensure the immunological compatibility of any blood, blood component, blood derivative, cell, tissue or organ that is intended for transfusion or transplantation.

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