Do not submit same batch no. of cough syrup to two different laboratories: DCGI tells Manufacturers, Exporters
New Delhi: Safeguarding public health, through a recent notification, the Drug Controller General of India (DCGI) has notified all drug manufacturers' associations and exporters not to submit the same batch of cough syrup to more than one laboratory at a time, as this practice is highly objectionable and not acceptable from a regulatory standpoint.
This came when two different government laboratories accredited by the National Accreditation Board for Testing and Calibration (NABL) received cough syrup from the same manufacturer/exporter with the same batch number for testing purposes.
In regards to the above, the Drug Controller General of India (DCGI) highlighted, "It is noticed that cough syrup samples of the same batch number, manufactured by the same manufacturer (for export purposes), are being received by two different laboratories for testing purposes, which is highly objectionable and not acceptable."
Furthermore, the notification added,
"It is hereby directed that no manufacturer or exporter shall submit the same batch nos. of cough syrup manufactured by them to two or more laboratories."
In addition, the DCGI also specified,
"If such cases are reported further, the samples of those manufacturers or exporters shall not be accepted for testing by any of the NABL accredited government laboratories."
The DCGI directive ensures that the evaluation of the cough syrup's quality and safety is conducted in a standardized and reliable manner. By prohibiting manufacturers from submitting the same batch of cough syrup to multiple labs simultaneously, the DCGI is taking a proactive step towards maintaining the integrity of the testing process and safeguarding public health. Submitting the same batch of cough syrup to multiple labs at the same time raises concerns about potential variations in test results and the potential for conflicting interpretations. This practice not only undermines the credibility of the regulatory process but also presents a risk to patient safety.
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