A European expert has cast doubt on a claim by Indian regulator CDSCO that it can assess and confirm the quality of an API supplier’s manufacturing operations in writing in just 30 days.
The Indian Central Drugs Standard Control Organisation (CDSCO) set the timeline in a document last month in which it also detailed how long it takes to review clinical trial and investigational new drug (IND) applications.
The 30 days needed to assess whether an API maker’s manufacturing practices are compliant with European standards – a requirement to ship to the continent since July – begins when the application is filed but does not include time for facility inspections.
This lack of plant inspection time is a concern for one European API auditing services firm in-Pharmatechnologist.com asked, whose spokesman told us 30 days is only enough time to do the basic admin and have written confirmation formally signed and issued.
“The underlying assumption therefore must be that any Indian company asking for this written confirmation is already under constant and rigorous GMP surveillance by the respective Indian Authorities. Otherwise, it seems not be possible to have an onsite audit scheduled, conducted and assessed within this time frame.”
The European Medicines Agency (EMA) told us that: "The time taken for such an assessment would depend on several factors including the level of knowledge the Indian authorities already have of the sites in question."
We asked the CDSCO if it does issue written confirmations based on this assumption but the organization did not respond.
GMP in India
What is clear, based on a spate of recent European Medicines Agency (EMA) and US Food and Drug Administration (FDA) warning letters , is that at present not all Indian API suppliers adhere to good manufacturing practices (GMP) standards.
This point was also made by the European auditor, who told us “[as a result of] the numerous recent findings of serious quality defects and GMP non-compliances by competent EU and other foreign health authorities, at well-known Indian API manufacturers, I have increasing doubts that the system of providing written confirmations is working as it should be.
Instead he suggested Indian API manufacturers should align themselves with “globally accepted” standards adding that assessment Indian government bodies “has to be independent, based on scientific knowledge and profound working experience in order to provide a reliable outcome.”
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) – which has had concerns about the efficacy of the European Union (EU) API import rules – declined to comment about the CDSCO 30-day timeline for the issuance of written quality confirmations.