Drug- For Importer

Drug- For Importer

 

We provide end-to-end solution to the manufacturers, importers, traders, marketers trying to venture in India for obtaining the swift approvals/NOC/Certifications by filing the unambiguous dossiers.

 

Authorized Agent/Registration Holder Support

In order to legally register, import and market, Drug products in India one needs to be compliant with the Indian regulations and legislation. When a company does not have a registered and physical office with statutory personnel and required licenses in India, a legal Indian Authorized Representative/ Agent needs to be formally appointed. The “Authorized Agent” represents your organization as your official Indian Authorized Representative/ Agent in accordance with Indian applicable regulatory legislation. We act as Authorized Agent for our clients enabling a speedy market entry.

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Marketing Authorization

In India, the CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality of drugs in the country. Marketing authorization is also given by CDSCO to different types of drugs under the provision of Drugs & Cosmetics Act 1940 and Rules 1945. The drug which needs to be imported has to be registered along with its site of manufacture and appropriate application need to be submitted to the regulatory authority to receive regulatory import permission for the same.

At CliniExperts, a team of professional will help you throughout the process of acquiring the Marketing Authorization. For more information on our services contact.

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Registration Certificate

The registration of the premises and also the drugs manufactured by the manufacturer meant for import into and use in India in a very basic regulatory document to carry out any of the further drug and cosmetic manufacturing, storing, importing etc. related business by the company seeking to do so.

At CliniExperts, a team of professional will help you throughout the process of acquiring the Registration Certificate. For more information on our services contact.

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Re-Registration

An application for re-registration shall be made to the Licensing Authority (CDSCO) in Form 40, nine months before the expiry of the existing certificate. With effect from 15th February 2016, the procedure for filing the application for import license, registration and re-registration certificate has been made online.

At CliniExperts, a team of professionals will help you throughout the process of acquiring the Re-Registration Certificate. For more information on our services contact.

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Import Licence

In India import, manufacturing, sale and distribution of drug is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945. An application for an import license is made to the licensing authority. The licensing authority shall grant the import licence on satisfying all the conditions as per the law. The process of obtaining an import licence can be smoothened by consulting an expert.

At CliniExperts a team of professionals will guide you through the process for acquiring the necessary import licence.  For more information on our services contact.

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Test Licence

A Test  Licence  is  given  for  the  Small  quantities of  drugs, the  import  of  which  is  otherwise prohibited under section 10 of the Drugs and Cosmetics Act and Rules, 1945, may be imported for the purpose of examination,  test  or  analysis  subject  certain conditions. Obtaining a Test Licence can be a cumbersome process, requiring filing of proper documents.

CliniExperts team provides end-to-end consultation service to obtain Test Licence. For more information on our services contact.

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Rule 37 Permission

This rule governs packing of patent or proprietary medicine imported in Bulk for retail sale. We provide assistance to our clients in obtaining the necessary permission.

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Shelf Life Extension

Shelf life Extension is obtained from CDSCO after the registration of product, when from further stability testing on product, it is established to have a shelf life exceeding than that mentioned on the label from previous analysis.

We, at CliniExperts help you obtain the Shelf life Extension for your products filing the apt documents facilitating speedy permission. For more information on our services contact.

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