COVID-19, Lockdown Affect Trials in India But Coping Efforts In Hand
The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.
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India saw a raft of vaccine and drug approvals in 2021, backed by pandemic-related accelerated regulatory processes, and outlined its intent to step up biopharma innovation in the country. Pharma wants some of the regulatory flexibility to stay, though experts are seeking increased transparency in the overall approach.
The new chief of the Indian Society for Clinical Research, Sanish Davis, tells Scrip how the Indian trials segment coped amid pandemic upheaval, emphasizing the need for stakeholder “sensitization and socialization” of the concepts of virtual/hybrid trials as part of efforts to mainstream these. The executive also shared his views on India’s trial waiver clause.
The Indian clinical research segment has managed to retain some buoyancy despite pandemic-related disruptions, with an estimated 70 global trials cleared to October by the regulator. But audiovisual recording of the informed consent process has been particularly challenging in the case of subjects in isolation wards.