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Regulators on strict scrutiny over drug manufacturing companies

Recently Britain’s regulatory body evoked its GMP certificate for Pfizer’s Chennai Plant over quality issues and put an alert on the products made there.

Between 2011 and 2016, 27 drug manufacturing plants in India received warning letters from the US Food and Drug Administration (FDA) for data integrity violations and 15 of them had import alerts issued against them. None of the alerts has been withdrawn, resulting in delayed product approvals or restrictions in export to the world’s largest pharmaceuticals market. About a third of all generic drugs consumed in the US are made in India, invoking greater scrutiny of plants in the country. Ranbaxy’s Plant inspections revealed the company had incomplete testing records and an inadequate programme to assess drug quality. In 2013, Ranbaxy had to pay $500 million in fines to the US government after admitting to data falsification and poor manufacturing practices.

For most foreign drug regulators, data integrity at Indian plants has been a concern. They accord high importance to data generated during research and manufacture to establish whether processes are well managed and if the finished product is safe. Plant sanitization is another area of concern. Unimark Remedies' plant in Gujarat received a warning last month after an inspection revealed the manufacturing area had open holes and dirt and birds in the manufacturing area as well as a lizard in the controlled processing area.

Regulators are interested in knowing how a company handles if any abnormal situation arises such as machine breakdown or a product failure. Hence foreign drug regulators have increased their vigilance on drug companies due lapses in transparent documentation especially about occasional abnormalities in production.


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