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Drugmakers may need designated expert to certify batches before sale

Drugmakers may need designated expert to certify batches before sale

What's behind this

The centre has proposed amendments to the drugs rules that would require manufacturers to formally authorise a qualified person with appropriate experience to release each batch and keep prescribed records; this could mean drugmakers need a designated expert to certify batches before sale, a development seen as significant for India’s $60‑billion pharmaceutical industry amid concerns over drug quality.

AI-generated overview from 2 outlets. It summarises their reporting and adds no reporting of its own.

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  • right · 1 outlet

    The development assumes significance for India's $60-billion pharmaceutical industry amid concerns over the quality of drugs manufactured in the country.

    — Livemint

RSS excerpt

The development assumes significance for India's $60-billion pharmaceutical industry amid concerns over the quality of drugs manufactured in the country.

Coverage arrived over 0 hours — first from The New Indian Express, latest from Livemint.

✓ Corroborated Coverage 2 news outlets reporting

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Livemint Center-Right HT Media Ltd. Current article

Drugmakers may need designated expert to certify batches before sale

The development assumes significance for India's $60-billion pharmaceutical industry amid concerns over the quality of drugs manufactured in the country.

The New Indian Express Center Express Publications (Madurai) Ltd.

Centre proposes authorisation of qualified personnel for drug batch release

NEW DELHI: The centre has proposed amendments to the drugs rules to mandate drug manufacturers to formally authorise a person with appropriate qualifications and experience for batch release of drugs and maintain prescribed records for every batch manufactured. The proposed amendments aim to…

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