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.
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.
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.
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.
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Commercial Testing Laboratories
Latest Notifications: Testing Laboratories
Commercial Testing Laboratories
Commercial Testing Laboratories: Procedure
Updated list of Medical Device Testing Laboratories (MDTLs)
List of Laboratory Instruments for Pharma & Cosmetics Industry
Safe Disposal of Unused Drugs: Urgent Need a Comprehensive Policy
Price of this breast cancer drug reduced
PLI Schemes Drive Rs. 21,861 crore in investments for Pharmaceuticals and Medical Devices
Drug alert: 28 out of 1302 samples declared as NSQ in May 2023
DCGI approves first indigenously developed animal-derived Class D Biomedical Device
Action to be taken against Pharmacies offering abnormal discounts: Karnataka
NPPA Guidelines: For change of Manufacturer in Notified Drug Formulations
NPPA revised Ceiling price of 15 scheduled formulations: June 2023
NPPA fixed retail price of 23 formulations: June 2023
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: