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Canada: A gateway to Pharmaceutical Business in North America

Author(s): Ajay Babu Pazhayattil

Journal: Pharmaceutical Reviews
ISSN 1918-5561

Volume: 4;
Issue: 3;
Date: 2006;
Original page

It is high time for Indian companies to seriously think of highly potential North American market. Always the GMP compliance and bio study requirements have been highlighted as the major hurdles.As a matter of fact, nothing is impossible. A step-by-step approach is the best way to involve and sustain in the North American market. It is imperative that most of the pharmaceutical manufacturing activities in North America will be outsourced to Asia in the coming years. Indian should not be reluctant in routing a major portion of this shift. A general misconception is that any North American initiative will cost heavily to the firm.Foremost snag for entry into a regulated market is the GMP approval from a regulatory agency. With respect to US the US FDA approval is obligatory. While Canada being a member of Pharmaceutical Inspection Co-operation Scheme (PIC/S), accepts any of the PIC/S member country inspection report. This includes MHRA, TGA etc. There is no need of an additional HPFBI inspection generally. In short, any of your existing PIC/S approval can bring you to North America. Health Products and Food Branch Inspectorate (HPFBI) is responsible for the GMP inspection and issue of Establishment Licence (EL) in Canada. Therapeutic Products Directorate (TPD) is responsible for product approvals, which includes issue of Drug Identification Number (DIN) and Notice of Compliance (NoC). Natural Health Product Directorate (NHPD) is responsible for natural product Product Licence (PL) and Site Licence (SL). Note that and EL or SL is only issued to a Canadian establishment. A foreign contract manufacturing site is added to an existing or new EL/SL by submitting the appropriate GMP inspection report.

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