Quality Assurance of Anti-TB Drugs

The quality assurance component of the National TB Elimination Programme (NTEP) drug supply system ensures that each drug used by a patient is safe, efficacious and has appropriate standards of quality.

For maintaining the quality of drugs, a system of pre-dispatch & post-dispatch testing of drugs is established.

• The testing of the drugs is as per the protocol developed by the Central TB Division (CTD).
• Random samples of second-line anti-TB drugs are picked up from all stocking points in the field.
• Collected drug samples are then sent for testing by an independent drug-testing laboratory contracted by CTD to ensure the quality.
• This has to be done based on communication sent by CTD to the concerned states and districts.

Resources

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, March 2021.
• Standard Operating Procedure Manual - Procurement & Supply Chain Management, MOHFW, GOI.

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