Authorities in the European Economic Area (EEA) issued non-compliance statements to 11% of the Indian drug manufacturing plants they inspected in 2016. The rate of non-compliance is far higher than the 1% recorded globally in 2016 and the 4-6% level seen in India in the three previous years.
In 2016, inspectors from the EEA performed good manufacturing practice (GMP) inspections at 108 facilities in India. These EEA inspections resulted in the issuance of 96 GMP certificates and 12 non-compliance statements, meaning more than one in every 10 plants inspected failed to meet regulatory standards. That makes India an outlier compared to both the GMP standards of other countries in 2016 and its own historic levels of compliance.
Inspectors from EEA countries — the European Union member states plus Iceland, Liechtenstein and Norway — visited 2,293 manufacturing facilities last year. These visits led to 24 statements of non-compliance and a GMP failure rate of 1%. When India is removed from the analysis, the rate of non-compliance falls to 0.5%. The global rates of non-compliance in 2015, 2014 and 2013 were 0.65%, 0.63% and 1.1%, respectively.
The rate of non-compliance in India was above the global average in each of those years, but the gap grew notably in 2016. In 2015, 2014 and 2013 EEA GMP inspectors issued non-compliance statements to 4.3%, 4.6% and 6.3%, respectively, to the Indian manufacturing plants they assessed.
EEA inspectors have only once failed plants in a country like they did in India last year. In 2013, EEA inspectors issued non-compliance statements to eight of the 71 Chinese sites they visited, giving the country a GMP failure rate of 11%. Since then, the rate of non-compliance statements issued to Chinese manufacturers has ranged from 5.3% to 7.7%.
The European Medicines Agency (EMA) presented the data in its annual report but offered no explanation for why Indian sites fared particularly badly in GMP inspections last year. EMA did detail the consequences for the recipients of the seven statements of non-compliance it issued in relation to centrally authorized products. One firm was prohibited from supplying the affected medicine in the EU. Another two companies were blocked from supplying active pharmaceutical ingredients for non-critical medicines.
EMA’s overview of the outcomes of good clinical practice (GCP) inspections in 2016 presented a more favorable take on quality in India. That analysis grouped India in with the rest of the Middle East and Asia Pacific region. Sites in this area accounted for 16% of GCP inspections last year and were responsible for 3.5% of the critical deficiencies identified.
Full EMA Annual Report 2016 can be viewed here.