My last mini blog focused on the USA agency response (COVID-19 – Regulators Respond – USA Focus), today we’ll be looking at India.
Many aspects of our lives have been affected by the pandemic which has seen cases and deaths around the world.
The pharmaceutical industry has by no means escaped this impact. We have experienced an increase in demand for products used to treat COVID-19 symptoms; the disruption of product supply; an impact on manufacturing, clinical trials and R&D, the curtailment of on-site inspections, problems in meeting timelines and requirements set by regulatory agencies, I could go on…
So far in this mini blog series we have looked at flexibilities from the EU, UK and USA regulatory authorities, the EMAMHRA, and FDA . Today we are looking at the regulatory agency in India, the CDSCO.
In March 2020 the DCGI (Drugs Controller General of India) prioritised assessment of COVID-19 test kits. In addition, manufacturers developing new IVDs (in-vitro diagnostic test kits) may contact DCGI directly for guidance on the applicable regulatory pathway. Priority applications are to be processed within 7 days.
Also in March the agency issued relaxed procedures for critical IVDs (e.g. for HIV test kits) for the duration of the COVID-19 pandemic. Port authorities holding consignments of these IVDs may release them based on a review of documents, protocol, manufacturer’s batch release certification and the history of compliance. However, importers are required to retain a sufficient quantity of IVDs for future analysis and to make a commitment to recall products that fail future laboratory tests.
In April 2020 Bioavailability/ Bioequivalence Centres which have applied for or are intending to apply for registration renewals 90 days prior to expiry will remain valid until any decision/ action is taken by the CDSCO.
In May 2020 the DCGI extended the expiry dates of WHO GMP/CoPP by 6 months for certificates expiring between March and August 2020.
In May the agency published a Rapid Response regulatory framework for COVID-19 vaccine development. This was superseded by the new guidance on vaccine development published in September 2020.
In July 2020 the agency extended the arrangements which gave special permission for the import of drugs with self life of less than 60%.
In September 2020 The agency released draft guidelines for COVID-19 vaccine development.