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Government Organisation Proposes Strict Guidelines For SubStandard Medical Devices

The Central Drugs Standard Control Organisation (CDSCO) in India has decided to prepare a set of guidelines for uniform action against the manufacture// of not of standard quality (NSQ) medical devices, diagnostic reagents, diagnostic kits etc. The guidelines drawn out would prescribe the exact procedures to be followed and action to be taken against the manufacturers by every state drug controller.

Officials say the current move is to make the existing system more comprehensive by including all kinds of drugs and medical devices that were left out from the existing guideline. A sub committee of the Drugs Consultative Committee (DCC) has been given the task of reviewing the guidelines and framing new guidelines for NSQ drugs within three months.

In a recent meeting of DCC it had taken note of the need for a fresh NSQ drug guideline also condemned the slow enforcement of NSQ guidelines by several state drug controllers. The DCC also felt that several drug controllers are slow in taking action against NSQ manufacturer for a long period hence they felt the need for all state drug controllers to intimate the action taken against the NSQ manufacturer within six months after receiving the test reports.

Medindia on Drugs:

Drug Toxicity / Drug Monitoring / Drug Therapeutic Levels

Therapeutic benefits of a drug on the market far outweighs it risks. All drugs are likely to have some side effects. Therapeutic monitoring of drugs is now readily available to make some of the drugs even safer. The current medindia utility has a list of 88 drugs with complete information in the following areas:

a. Normal levels and critical levels where the drug is likely to be toxic.

b. Physiological action and toxicity of the drug.

c. Interpretation of drug levels.

d. Laboratory test methods for monitoring drug levels.

e. Therapeutic monitoring and management of drug levels.
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