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India Tightening Inspections on Raw Materials

Cheaper is not always better. The cost of drug development demands that the pharmaceutical industry review the cost of all components of the program. In doing this, often the choice of the active pharmaceutical ingredient (API) manufacturer is driven by cost. Many of the API’s and raw materials are now coming from China. Any company currently working with China must be alert to the many problems that have been occurring with raw materials sourced from China. The availability of cheaper raw materials from China and the increase in production of API’s in India has lead the health department of India to require inspections of the raw materials being imported from China.

Many pharmaceutical companies consider inspecting the source of their API. However they do not consider inspecting the source of the starting materials for the manufacture of the API. India has realized the need for this step in the process.

At the same time the FDA is considering how to establish the responsibility of a CMO as an extension of the pharmaceutical company that is contracting the work. This will increase the need for vigilant oversight of the contractors by the drug product sponsor. The concept will be a shift in the thinking of the pharmaceutical industry, the buck stops with the Sponsor.