Ph-Ch29:Quality Assurance of Drugs

Procurement of good quality anti-Tuberculosis (TB) drugs and ensuring the quality of drugs till the consumption point is one of the prime objectives of National TB Elimination Programme (NTEP).

To ensure the quality and efficacy of anti-TB drugs, a comprehensive NTEP Quality protocol has been developed and is being followed during the procurement mechanism and supply chain management of drugs up to the consumption points. Simultaneously, quality assurance of anti-TB drugs has also been aligned with Ni-kshay Aushadhi application for easy reporting and recording from the Central to the peripheral level.

Fig 1: Quality assurance of drugs under NTEP

Resources

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

2. NTEP training modules 5-9; Central TB Division, MoHFW, GoI 2020.

Assessment:

Quality Assurance of Drugs in NTEP is it ensure that, Each drug used by a patient is safe, efficacious and has appropriate standards of quality.

Procurement of good quality anti TB drugs and ensuring quality of drugs till consumption point is one of the prime objectives of NTEP. To ensure quality and efficacy of anti TB drugs, a comprehensive Quality protocol has been developed and is being followed during the procurement mechanism and supply chain management of drugs up to the consumption points.

Sample Collection Protocol 

Maintaining quality of drugs, a system of pre-dispatch & post-dispatch testing of drugs is established.

As per the protocol developed by CTD-

                         Random samples of First / second-line anti TB drugs shall be picked from all stocking points in the field.

                         Sent for testing by an independent drug testing laboratory contracted by CTD.

                         This should be done based on communication sent by CTD to the concerned states and districts.

Resources

1. NTEP Training Modules 5to9, Central TB Division, MoHFW, GoI 2020

Assessment:

Pre -Dispatch Inspection

•  CTD to procure drugs through the Procurement Agency
• Procurement Agency will award contract to the Manufacturer/Suppliers after following the technical specification
•  As per Technical Specification, Manufacturer will conduct pre-dispatch inspection for Quality Check
• Once clean report is received, the drugs to be dispatch to the consignee (GMSD/CMSS/SDS

•  CTD hires a Lab agency
• Lab Agency pick drugs from the sites as per directed by the CTD
• Picked drugs will be sent to Laboratories by agency for Testing
• Test report to be shared with CTD
•  CTD to disseminate the reports to all level

Resources

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

Assessment:

Directions for collection of drug quantities for testing

• Central Tuberculosis (TB) Division will issue directions every quarter to concerned Government Medical Store Depots (GMSDs) and states for the collection of drug samples as per National TB Elimination Programme (NTEP) Quality Assurance (QA)  protocol.
• Directions will be accompanied by the name of the drugs and the number of batches to be collected from respective drug stores.
• Generally, at least two batch numbers of drug samples selected randomly shall be sampled for testing from GMSDs, State and District Drug Stores.
• From Tuberculosis Unit (TU), only one batch number of drugs may be sampled. In case of stock shortage, samples will not be taken from TU.

Table 1: Quantities as per formulations to be collected for testing

Procedure for collection of drug samples for testing

Figure 1: Overview of collection and sending of drug samples for quality testing in NTEP

The following procedure should be followed for the collection of drug samples:

1. As far as possible, the officer-in-charge should draw drug samples from original, unopened boxes /containers/ packs.

2. The sample drawn shall be divided into two equal parts, one half to be sent to the contracted laboratory in sealed condition and another half to be retained at the drug store in sealed condition.

3. The sealed pack of drugs collected should indicate on its label or otherwise:

   (1) Drug name

   (2) Quantity

   (3) Batch No.

   (4) Date of Manufacturing

   (5) Date of Expiry

   (6) Supplier Name

   (7) Procurement Agency

   (8) Manufacturing License No.

   (9) Source of collection besides caution (if any) printed on the label for use/ storage of the product.

 4. Information as above should be repeated in a covering letter, sealed and sent along with the sealed sample to the laboratory.

 5. A copy of the covering letter should also be sent to Central TB Division.

 6. Sample quantities collected should be such that the samples collected can be analyzed twice (as indicated above, by dividing into two equal batches).

7. Half of the sample collected should be sent to the selected laboratory in a sealed condition and the remaining half-sample of the same batch should be retained in sealed condition at the concerned drug stores until the lab report on the sample is received.

8. Record the quantities issued to testing laboratories in the stock register and Ni-kshay Aushadhi.

Resources

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

Assessment:

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.

Assessment:

Content

After receiving directions about the collection of drug samples for QA from Central TB division, the respective stores need to record all the details in the Nikshay Aushadhi. Various steps involved in this process are as follows:

Process overview:

Detailed procedure

Step 1: Go to the Nikshay Aushadhi website and click on login. Enter your user ID, Password, captcha text and click login.

Step 2: Reach the ‘Drug Quality Inspection Issue Detail’ window following the path:

Home>Services>Quality Control Management> Drug Quality Inspection Issue Detail.

Step 3: Click on the ‘drug finder’ Tab and select drug and batch number required for testing and enter the quantity.

Note: This quantity has to be retained at respective drug store in sealed condition till further instructions from Central TB division.

Step 3: Click ok to save your selection and repeat Step 2 to add more drugs if any.

Step 3:  Enter desired details- lab name, controller ID and Controller name in the relevant columns and click on ‘Save’ tab to complete the process.

Figure 1: Saving the details

Source: Nikshay Aushadhi portal

Resources

1.Standard Operating Procedure Manual Procurement & Supply Chain Management- Central TB Division, Ministry of Health and Family Welfare, Government of India 2018

2.Nikshay Aushadhi Manual-Central TB Division, Ministry of Health and Family Welfare, Government of India

Assessment

Desk monitoring of supply chain

Desk monitoring of supply chain refers to the process of remotely monitoring drug stores in the network for their activities and performance. Under NTEP, this process can be done through Nikshay Aushadhi. Nikshay Aushadhi may help in real-time monitoring of supply chain by generating various reports related to consumption, requirement, and expiry management. Following are the ways that will enable the officer-in-charge to effectively monitor the supply chain through Nikshay Aushadhi.

Generation and Analysis of reports

Nikshay Aushadhi autogenerates a number of reports that keep a track of the stock availability, consumption, and expiry of supplies. These include Stock in Hand Record, Stock ledger report, expiry details report, Issue report, Stock ledger report, receipt register and issue register.

Analysis of the reports enable the Officer in-charge to ensure that adequate stock of supplies for consumption is available at the stores. At the same time, it will highlight the stores that are overstocked, understocked, or have supplies that have a near expiry date. This would allow the supervisor to take timely actions to ensure that these imbalances are corrected without any wastage.

Random checks

 In addition to reviewing and analysis of monthly/quarterly reports, the officer in-charge may randomly check the reports at any point in time to ensure that the records about the receipt and consumption of supplies are updated on real time basis.

Audit trails:

The officer in-charge can check the audit trails i.e., transaction related to the receipt and consumption of supplies by analyzing the reports to ensure that relevant records are maintained on real-time basis. The officer in-charge through this process would be able to check information about the receipt, consumption, and balance stock of any item in the inventory at random.

Performance of the sub-stores

Analysis of reports such as the enquiry status will enable the officer in-charge to assess the performance of the sub-stores in terms of their Nikshay Aushadhi usage status. Analysis of these records will help in determining whether the relevant entries are being done on real time basis or not. In addition to this, thorough inspection of the reports will give officer in charge a fair idea about quality and accuracy of the data entered by the sub-stores.

Any problems/gaps identified can be discussed with the sub-stores through regular video conferencing.

Resources

Standard Operating Procedure Manual Procurement & Supply Chain Management, Ministry of Health and Family Welfare, Government of India 2018

Assessment