Follow up after drug testing

Quality Assurance (QA) reports

• The contracted laboratory for quality assurance of National TB Elimination Programme (NTEP) drugs shall share drug quality reports as per the defined timelines to Central TB Division (CTD).
• The stipulated time is about 20 days for parenteral formulations & about 15 days for other drugs (capsule/tablets).  
• Once quality reports of drugs are shared by the contracted laboratory, the same shall be shared further with the states.

The sealed drug samples may be opened and used in case the lab report indicates acceptable quality. However, in case of drug samples are declared as sub-standard, necessary action shall be taken by the CTD.

CTD shall communicate to the State about the sub-standard drugs and update the reports in Ni-kshay Aushadhi. Consequently, said batches which are declared sub-standard, shall be segregated in the Ni-kshay Aushadhi.

Precautionary Measures in Case of Sub-standard Drugs

1. Stocking units down the line shall immediately be instructed to stop further consumption and issues from the batch declared substandard.
2. Specific instructions shall be given to stocking units / Directly Observed Therapy Shortcourse (DOTS) centres to replace unconsumed drugs of a substandard batch from boxes/ drugs allocated to patients with drugs of a different batch.
3.  Unconsumed/ unused substandard drugs shall be labelled ‘substandard’ and carefully segregated in stores, in such a way that there is no possibility of their being reissued to patients.
4.  A detailed record shall be kept of segregated substandard drugs taken.
5.  CTD shall take all further necessary action for declared sub-standard drugs with concerned procurement agencies.

Repeat Testing

The following procedure is to be followed in case of a declared sub-standard drug:

1. Laboratory reports suggesting sub-standard drugs may be challenged/disputed by the manufacturer/ supplier and they may request CTD to carry out an additional laboratory test through an independent, government-approved agency, e.g. Central Drugs Laboratory (CDL), Kolkata.
2. CTD shall accordingly give instruction to Central Medical Services Society (CMSS)/ concerned Government Medical Store Depot (GMSD)/ State Drug Store (SDS)/ District TB Centre(DTC) /Tuberculosis Unit (TU) for dispatching the sample retained in sealed condition, for another round of testing to CDL, Kolkata. If a repeat testing report suggests that the quality of drugs tested is good enough for general administration, then instructions shall be issued by CTD to CMSS/GMSD/ SDS/ DTC and Stocking Units to resume issues/ consumption thereof. In case repeat testing confirms the sub-standard quality of drugs, CTD shall send a copy of the report to the procurement agency for further necessary action.

Resources

1. Standard Operating Procedure Manual- Procurement & Supply Chain Management; RNTCP, MoHFW, GoI 2019.

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