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Last year, we had interviewed Parul Oza, Managing Director of CRMO Pharmatech, to better understand ICH Q11, and the US Food and Drug Administration’s adoption of the same.
The ICH Q11 are guidelines for the development and manufacture of drug substances (chemical entities and biotechnological/biological entities). These have been developed by the Geneva-headquartered International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the process is recommended for adoption to the regulatory bodies of the European Union, Japan and the US.
CRMO Pharmatech is an Indian company based in Ahmedabad established with a vision to provide complete outsourcing solutions to the pharmaceutical industry.
This week, we speak to Oza about the challenges facing the API (active pharmaceutical ingredient) industry in 2018, how companies are reducing dependence on China, the new regulations changing the dynamics of the API industry and the key trends for 2018. Here are some excerpts from the interview:
In
2018, what according to you are the key challenges facing the API industry?
2018 is expected to be a transformative year for the API industry. Over the last two decades, China has become the central, global source of APIs and intermediates to the global pharmaceutical industry. That’s beginning to change.
The prices of APIs and intermediates are moving up. Supply sustainability can no longer be taken for granted as the Chinese government clamps down on factories which fail to comply with environmental norms.
While the industry has been focused primarily on low-cost sourcing solutions, the absence of assured supply is something companies need to start preparing for as interrupted supply will lead to a loss of market share that companies may find difficult to regain.
Although India submits more than 50 percent of the drug master files (DMFs) for APIs to the US Food and Drug Administration (USFDA), almost all bulk APIs and key starting materials (building blocks) are being sourced from China.
In addition, concerns over GMP compliance continue to emerge out of India and China. While the number of non-compliances for API manufacturing were relatively low in 2017, we expect the USFDA to overcome its staffing challenges this year and increase its inspections in Asia.
Increased scrutiny of manufacturing operations coupled with USFDA/EU’s agreement over mutual recognition of inspections will further separate the compliant factories from the non-compliant ones.
This year will also see the impact of two landmark regulations — new regulations on elemental impurities, and continued enforcement of ICH Q11.
The elemental impurity regulation focusses on the contamination of metals in products and this is often a direct result of the state of the equipment used by a factory. The ability to comply requires factories to invest capital where necessary.
The ICH Q11 guideline, on the other hand, mandates suppliers to have a far wider control of their manufacturing processes, and in some cases that of their starting material suppliers, than what was required in the previous years.
Together, these two regulations are going to put more pressure on suppliers to comply with the growing expectations of the regulators.