DCGI asks importers to submit undertaking on product quality

As part of ease of doing business, the DCGI’s initiative aims to ensure that importers strictly comply with conditions of import license and maintain integrity of drugs.

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Last Updated on September 25, 2020 by The Health Master

Aiming at faster clearance of import consignments at ports, the Drugs Controller General of India (DCGI) has asked importers to submit an undertaking along with a bill of entry that packaging of their consignment is not damaged and content of drugs has not deteriorated.

As part of ease of doing business, the DCGI’s initiative aims to ensure that importers strictly comply with conditions of import license and maintain integrity of drugs.

As per a notice issued by the DCGI recently, in light of doing business and for utilizing fast track system of risk management system, with ICEGATE integration for online clearance of imported drugs and cosmetics, it is proposed that the human interface may be reduced by devising method, while ensuring that the integrity of drug/cosmetics, its packages and seal is intact before the release and out of charge.

Therefore, it is a responsibility of the importer to ensure the same and furnish the undertaking with each integrated declaration or bill of entry that the packaging is not damaged/broken/destroyed and the content of drug/ cosmetic has not deteriorated in a prescribed format, it stated.

Besides submitting the said undertaking at the time of import, all importers are required to furnish label of respective consignment, certificate of analysis (COA) of release of batch and import license/permission along with bill of entry and other documents as per Drugs and Cosmetics Rules, 1945 at the port office.

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Each importer is required to comply with the conditions of the import license or the no objection certificates (NOCs) issued under the D&C Act.

Welcoming this, Sahil Munjal, vice chairman, Pharmexcil said, “It is a welcome step by the government to release all import consignments with importer’s declaration that package seal is intact and package is not broken/damaged. This will help importers to release import consignments from ports/airports without unnecessary delays. It is a welcoming step by DGCI in ease of doing business.”

Said Nipun Jain, chairman, Small and Medium Pharma Manufacturers Association “Importers have been complying with conditions of import license under D&C Act. The DCGI’s recent mandate that importers submit requisite documents along with an undertaking that their consignment is intact and is fit for consumption before the release of imported goods from ports/airports, is in the direction of ensuring importers’ strict compliance with provisions of D&C Act. It’s a welcome step.”

However, an industry insider stated that there are certain unscrupulous importers who manage to import and sell unregistered/prohibited pharma products in the country by mislabeling and misfiling bill of entry with customs’ ICEGATE. They get imported consignments released from ports and airports with tacit support from customs officials without securing NOC from additional drugs controller (ADC). This is posing risk to public health.

The DCGI needs to look into the issue and coordinate with customs authority to check the import of unregistered/banned pharma products in the country, he added.


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