NABL follows rigorous process while giving accreditation to a drug testing laboratory: NABL CEO

The National Accreditation Board for Testing and Calibration Laboratories (NABL) follows a rigorous process while giving accreditation to a drug testing laboratory. It includes the scrutiny of application as well as quality management system (QMS) documents in accordance with ISO/IEC 17025:2017, informs N Venkateswaran, CEO, NABL.

“This is followed by assessment of the laboratory wherein technical competency of the laboratory is evaluated. The evaluation is based on several assessment methodologies including but not limited to test witness, document review, and interview of concerned personnel,” Venkateswaran further explains.

Industry experts have been urging the Union health ministry to also authorize the NABL accredited private testing labs to test the cough syrup samples before exports, which are currently facing a huge backlog ever since the Directorate General of Foreign Trade (DGFT) issued a public notice on May 22, 2023.
The notice stated that India will allow the export of cough syrups only after the samples are tested in a government certified laboratory. This order comes after India-made cough syrups were found to be contaminated, and were linked to the deaths of dozens of children in Gambia and Uzbekistan.

The NABL accreditation plays a very important and relevant role at a time when there is so much hue and cry around the backlog of cough syrup samples not being tested on time before exports which is negatively impacting the business and credibility of the Indian pharma industry.

Venkateswaran further explains that in order to ensure the validity of results, laboratories must have participated satisfactorily in proficiency testing as well in inter-laboratory comparison. This includes use of Certified Reference Materials (CRM), which are the other means to evaluate the metrological traceability of its measurement results. “Accreditation serves as a mechanism to enhance confidence in the competence and reliability of organizations involved in regulated activities. It demonstrates their adherence to quality standards and regulatory requirements, providing assurance to regulators, industry stakeholders, and consumers alike,” he adds.

“Accreditation is the third-party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out specific conformity assessment tasks. Laboratory accreditation is a means to improve customer confidence in the test reports issued by the laboratory so that the end-user shall accept the reports with confidence,” Venkateswaran said.
The NABL plays a vital role, providing accreditation to laboratories. NABL has been established to provide government, industry associations, and industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories.

The NABL as an accreditation body has been providing accreditation services for more than four decades, and is a Mutual Recognition Arrangement (MRA) signatory to the International Laboratory Accreditation Cooperation as well as Asia-Pacific (APAC) for the accreditation of testing and calibration laboratories as per ISO/IEC 17025, medical laboratories as per ISO 15189, proficiency testing providers (PTP) as per ISO/IEC 17043 and reference material producers (RMP) as per ISO 17034. Such MRA reduces technical barriers to trade and facilitates acceptance of test/calibration results between countries which MRA partners present.

The ILAC started as a conference in 1977 to develop international cooperation for facilitating trade by promoting the acceptance of accredited test and calibration results.

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