Industry

CDSCO implements transparent reporting system for Cough Syrup exports

This proactive approach aims to streamline processes and improve work distribution among the labs.

The Health Master

June 16, 2023

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Last Updated on October 6, 2024 by The Health Master

Transparent Reporting System for Cough Syrup Exports

The Central Drugs Standard Control Organisation (CDSCO) has taken significant measures to enhance the quality and safety of cough syrup exports.

In a move to ensure time-bound testing and the release of reports, CDSCO has begun providing daily updates on the number of cough syrup sample batches submitted to each laboratory prior to export.

This proactive approach aims to streamline processes and improve work distribution among the labs.

Additionally, the Directorate General of Foreign Trade (DGFT) has issued guidelines that restrict the export of cough syrups unless they pass quality tests conducted by designated laboratories.

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Enhanced Transparency in Testing Process:

CDSCO’s Daily Updates:

CDSCO now publishes daily reports on the number of cough syrup sample batches received by central and state drug testing laboratories. This transparent reporting system helps ensure efficient work distribution and timely release of test reports.

Rationalized Sample Submission:

Manufacturers and exporters can refer to the daily list provided by CDSCO and submit samples to laboratories with fewer pending batches, ensuring balanced workload distribution among the labs.

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Standardizing Testing Procedures:

Standard Operating Procedures (SOPs):

In May, the DCGI issued SOPs to streamline testing processes and ensure consistent quality across all laboratories. These procedures serve as guidelines for conducting tests on cough syrup samples.

Designated Laboratories:

DGFT’s notification specified the laboratories authorized to conduct tests and issue Certificates of Analysis (CoAs).

These laboratories include:

The Indian Pharmacopoeia Commission, Ghaziabad;
Central Drugs Laboratory, Kolkata;
Central Drugs Testing Laboratories (CDTLs) in Chennai, Mumbai, and Hyderabad;
Regional Drugs Testing Laboratories (RDTLs) in Chandigarh and Guwahati.
Additionally, any NABL-accredited State Drugs Testing Laboratory can perform the tests and issue CoAs.

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Mandatory Testing and Export Requirements:

Amended Export Policy:

Effective from June 1, 2023, the DGFT amended the export policy for cough syrups. Now, export is permitted only if the cough syrup passes the designated laboratory’s quality tests, and a Certificate of Analysis (CoA) is submitted.

Testing Documentation:

Manufacturers must submit their product export license, export order, and other necessary documentation as part of the testing process.

Ensuring Quality:

As part of its commitment to ensuring the quality of medicines, the Government of India has implemented various measures, including the DGFT’s order.

Conclusion:

CDSCO’s proactive approach to transparent reporting and streamlined testing processes demonstrates a commitment to enhancing the quality and safety of cough syrup exports.

By providing daily updates and enforcing stringent testing requirements, the authorities aim to prevent the export of substandard products.

These measures will help protect consumers and safeguard India’s reputation as a reliable source of high-quality pharmaceuticals.

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