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CDSCO issues draft SOPs for handling of Not of Standard Quality drug samples

Ramesh Shankar, Mumbai
Monday, June 19, 2017, 08:00 Hrs  [IST]

To lay down the procedure for declaring a drug sample as Not of Standard Quality (NSQ), the Central Drugs Standard Control Organisation (CDSCO) has issued the draft standard operating procedures (SOPs) for handling of NSQ drug samples. The DCGI office has now asked all the stakeholders to send their suggestions and comments, if any, to the DCGI office by July 12, 2017.

The CDSCO's action in this regard comes as per the recommendations of Drugs Consultative Committee (DCC) made in its 50th meeting held on November 4 to 5, 2016.

As per the draft SOP, whenever the analysis result of any sample is not within the range of specified limits, it is referred to be Not of Standard Quality (NSQ)/out of specification (OOS).  Such a sample has to undergo through certain set of procedures.  

On getting an OOS, the analyst immediately should report the OOS to HOD/Authorized person. All the solutions and standards used during test should be preserved. HOD/Authorized person should review the results reported by the first analyst and investigate the error if any.  Error may occur during preparation/handling of samples like improper weighing of sample, loss of sample due to spillage, error in dilution, error in preparation of reagents and solutions or due to any testing instrument malfunctioning.

Authorised person should then allot the sample to another or senior analyst (as per the availability) for testing. Retesting refers to the analysis of the original homogenous/remaining portion of the sample.  After the second analysis, the sample either complies with or does not comply with the specification applicable. If the sample does not comply with the specification and the results match with the results of the first analysis plus-minus 2 per cent, then the higher value will be reported and the sample is declared Not of Standard Quality.

If the sample complies with the specification and the results do not match with the results of first analysis, then the sample is sent for the third analysis.

After third analysis, the results either match with first analysis or with the second analysis. If the results of third analysis comply/match with the results of first analysis within ±2%, then the higher value of the two will be reported and the sample is declared Not of Standard Quality.  If the results of third analysis comply/match with the second analysis within ±2%, then the higher value of the two will be reported and the sample is declared as of standard quality.  

After the completion of retesting process, if the test/sample is found NSQ, the  HOD/Authorized person will review and investigate the complete analysis/procedure and prepare a final investigation report.

The test report is sent to the Govt. Analyst/ Director for final approval and release. All the data of initial testing, resting and investigation is retained with the report.  In case of Not of Standard Quality, the report has to be reported or uploaded on the website within 24 hours of completion of its testing including review process.

In the  50th meeting of DCC, the issue relating to the guidelines issued for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalty; and lack of SOPs and uniformity in administration of the provisions of DC Act 1940 and Rules 1945 came up for discussion.  A sub-committee under the chairmanship of Dr Harshadeep Kamble, then Commissioner, Maharashtra FDA, was constituted to revisit the guidelines in the light of present day context and recommend for necessary revision. The committee was also asked to recommend for preparation of guidelines, SOPs for taking administrative actions by the licensing authorities, in case of non-compliance with the provisions of the Act and Rules including samples found to be not of standard quality, adulterated, misbranded or spurious.


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Ashok Devkate Oct 20, 2017 9:44 AM
If product is not official that case analyst need to be confirmed MOA followed by Govt.analyst & drug mfg.site is same.It should be mentioned in SOP.
maninder Jul 12, 2017 3:14 PM
what happens in case the third analysis result are different from first and second and do not match either?
Sheela p Gauli Jun 19, 2017 10:04 PM
In this draft SOP, there is no guidelines regarding the method to be followed in case of P and P drugs.
Satyanarayan Garg Jun 19, 2017 8:41 AM
SOP idea itself commendable for compliance by government agency like Govt.Analyst or Director CDL . Proposed SOP provides for three layer of verification and if NSQ report still challenged by manufacturer then another three time analysis will be done at Director CDL level.
If even after these six level screening sample is found to be NSQ then penalty should be equally stringently enforced .
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