DCGI asks manufacturers: Not to submit same batch of cough syrup to multiple Laboratories

This discovery has triggered serious concerns about the integrity and quality control measures in the pharmaceutical industry.

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DCGI CDSCO Regulator Drugs Controller General India
DCGI

Last Updated on December 31, 2023 by The Health Master

Cough syrups testing

In a startling revelation, two different NABL government laboratories have recently reported receiving identical cough syrup samples with the same batch number, all manufactured by a single exporter for the purpose of international trade.

This discovery has triggered serious concerns about the integrity and quality control measures in the pharmaceutical industry.

The Drugs Controller General India (DCGI), Central Drugs Standard Control Organization (CDSCO) have taken immediate action to address the issue and have issued a directive to all drug manufacturers and exporters.

Sending identical batches to multiple laboratories for testing is considered highly objectionable and a clear violation of industry norms.

Immediate Directive to Address the Issue

To ensure transparency and maintain high-quality standards in the pharmaceutical sector, the DCGI issued a directive on 28-07-2023 with immediate effect.

The key points of the directive are as follows:

Prohibition on Multiple Submissions:

All drug manufacturers and exporters have been strictly instructed to refrain from submitting the same batch number of cough syrup to more than one laboratory for testing purposes.

This measure aims to prevent any potential discrepancies or inconsistencies that may arise from multiple testing procedures.

Consequences of Non-Compliance:

Non-compliance with this directive will have serious repercussions.

If any further instances of identical batch submissions to multiple laboratories are reported, the samples from the concerned manufacturer/exporter will not be accepted for testing by any NABL accredited Government laboratory.

Additionally, legal action may be taken against the non-compliant parties, and their export privileges may be affected.

Commitment to Upholding Quality Assurance

In a joint statement, the DCGI, CDSCO emphasized their dedication to maintaining the highest standards of drug testing and quality assurance within the country.

The pharmaceutical industry plays a crucial role in ensuring the health and well-being of millions, both domestically and globally, and preserving the reputation of Indian medicines is of utmost importance.

Call for Compliance

This directive extends to all laboratories under the CDSCO and state-level laboratories involved in testing cough syrup samples for export purposes.

Strict compliance with the directive is expected from all parties involved to avoid any further complications.

The authorities believe that adhering to these regulations will enhance transparency, accountability, and the credibility of India’s pharmaceutical exports.

It is also crucial for ensuring the safety and efficacy of medicines for consumers worldwide.

Conclusion

The cough syrup scandal has raised concerns within the Indian pharmaceutical industry, prompting swift action from the DCGI, CDSCO.

The directive prohibiting the submission of identical cough syrup batches to multiple laboratories aims to strengthen quality assurance measures and maintain the country’s reputation as a reliable exporter of high-quality medicines.

Pharmaceutical manufacturers and exporters are urged to comply with the directive to ensure transparency and uphold the industry’s integrity.

The health and safety of patients worldwide depend on adherence to stringent quality standards, and the authorities are committed to maintaining these standards for the greater good of public health.

For any inquiries or clarifications regarding this directive, concerned parties are advised to contact the office of Drugs Controller General India (DCGI), Central Drugs Standard Control Organization (CDSCO).

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