The MHRA has cleared Hyderabad based CRO Anacipher to trial drugs destined for the UK market after a “virtual” inspection.
AnaCipher received GCP & GLP accreditation from the Medicines and Healthcare Products Regulatory Agency in August after a document and data-based audit conducted during May.
The assessment focused on the contract research organization’s (CRO) ability to carry out bioequivalence studies at its facility at the heart of India’s drug industry in Hyderabad, Telangana.
The facility – which has also been inspected by the US Food and Drug Administration (FDA) – houses 98 beds and provides services for both bioequivalence and bioavailability (BA/BE) studies.
The MHRA accreditation was welcomed by Aditi Kare Panandikar, Managing Director of Indoco Remedies Limited, AnaCipher’s parent company.
“This is an exciting step in our journey of excellence and a validation of our adherence to delivering quality services to our customers worldwide.”
AnaCipher claims to have completed more than 500 studies in therapeutic areas ranging from cardiovascular disease and diabetes through to oncology and anti-infectives.
The MHRA decision prompted a surge in Indoco Remedies share price. According to India’s Business Standard newspaper the firm’s share price rose 0.7% to Rs 450.8 on the day of the announcement.
Virtual realities
The MHRA, like the majority of regulatory agencies, modified its inspection and assessment practices as a result of the coronavirus pandemic.
According to data shared by in March agency auditors have conducted more than 750 remote GxP inspections since early last year using a variety of technologies and systems.
“A variety of file-share platforms have been used, including those already established in the companies inspected, as well as FileShare and, more recently, Teams Channels.”
These systems allow inspectors to share large data files and host discussions with organizations under assessment “replicating the inspection team being ‘in the room’ together as far as possible.”
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