Dr. Reddy's

At the heart of this drive is the need to maximise automated output instead of relying on manual output. Human intervention is prone to errors and variations. But with machine, we can be assured that the results can be replicated.

The drive encompasses the switch from semi-automatic to automatic machines, installation of new banding machines, deployment of size-sorting machines and camera equipped inspection machines.

As a result of using automation and new technologically advanced machines, defects are usually absent and where existent have been significantly reduced. The need and dependency on human inspection has been minimised to a great extent.

Product Recall	CASE STUDY

CHALLENGE

	Concerns were being raised in the US on the size of a few of our pills. It was an issue isolated to four products, one specific lot per product, or four lots in total.

INTERVENTION

We demonstrated exemplary product stewardship through the voluntary recall which was initiated without prompting from any regulatory authority. We recalled one lot each of . - Citalopram 40 mg in bottles of 100 tablets, Fexofenadine 180 mg in bottles of 500 tablets, Pravastatin 10 mg in bottles of 90 and 500 tablets and Risperidone (plain) 25 mg in bottles of 500 tablets. The transparency, the speed of action and the alertness of concerned divisions were the silver linings.

“It was a demonstration of courage and honesty. This action of Dr. Reddy’s has strengthened its fiduciary position vis-à-vis its US customers and the US Food and Drug Administration (USFDA).”

- Dr. K. Anji Reddy,
Founder Chairman, Dr. Reddy's

The root cause analysis led to a massive automation drive. We realised that there were instances of the machines working fine but dependant on people to run them right. Hence, these lines were upgraded or modernised to identify and isolate a defective product without human intervention.

OUTCOME

This voluntary recall and the transparency of the exercise have strengthened the resilience of our business.

The upgradation of the line led to a comprehensive reduction in the variations beyond specifications.

We also recognised the need to go beyond rigorous testing and tailpipe quality checks and accelerated our adoption of Quality by Design – an initiative to implant quality right from the development stage.

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