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.

If new to the market it is advisable to start as a contract manufacturing partner of a North American manufacturer or marketing firm. A local contact or representative is essential because they help in reaching out a North American customer, get the current trend, will help build-up goodwill and will give the customer a local contact point. It is not necessary to have a dedicated office. There are pharmaceutical or marketing professionals willing to work on a commission basis. On the contrary, involving independent consultants will result in colossal fees. It will cost only up to $500 if interested in registering the company's subsidiary North American firm. Warehousing and testing requirements if any can be outsourced to a third party approved facility or the customer facility itself.

Canada can act as a low cost, low risk launch pad to the whole of North America. As previously described a regulated market GMP inspection report (PIC/S) is accepted by HPFBI. It should be also noted that most of the Canadian manufacturing or marketing firms have a major US market share. Contract manufacturing association with a Canadian firm will ultimately lead to a faster US launch. Canadian drug export revenues have more than doubled since 1998, with 85 per cent of exports going to the United States (Industry Canada, Life Sciences Branch).

Bio study requirements
The second major issue cited is the bio study requirements. It is true that an average of $350,000 per product need to be invested on bio study for North America. It is also a fact that Health Canada-TPD do not accept a study conducted on US reference product and vice versa. There is no doubt that the primary need is to start-up business activities in North America. Any proposal to bypass the bio study investment should be a big relief and need to be utilised to the fullest. Yes, the guideline presents few products where manufacturers are waived of the bio study requirement. TPD has a list of products under the category "labelling standards" which do not require a bio study report. A new DIN for these products is approved within 1-2 months time. They include: Acetaminophen tab, Ibuprofein tab, Dimenhydrinate tab etc. These OTC products are of high sales volume (refer IMS data for Canada). Only a handful of firms are involved in their manufacturing. FYI: Average generic brand store shelf price in CAD for Acetaminophen 500 mg-100 tab bottle-$5, Ibuprofen 200 mg-100 tab bottle-$10, Dimenhydrinate 50 mg-30 tab bottle-$5. Once established working with OTCs, the firm can graduate to bio study required products soon. This model will also help generate the much-needed initial revenue to further work on prescription products.

Now, for contract manufacturers who do not have a regulated market GMP approval can also have their share in Canada. This is by starting with NHPD regulated products. A typical high volume NHPD product is Sennoside tablet. As far as NHPD site licensing guidelines, the foreign site needs to be only inspected and certified by a third-party auditor. This inspection report is to be submitted by the Canadian applicant for his Site Licence. Any number of foreign or local manufacturing sites can be added to this application.

Manufacturers target US market
Most of the Indian manufacturers target US market though it is highly non-permissible and expensive; considering its market size and the more established submission processes. This has left Canada with fewer Indian players. Though gradually, all the major Indian firms will end up in Canada and majority of Canadian market share should go to the initial few. According to a recent Canadian PMPRB study, changes in the price of existing drugs did not necessarily contribute to increased expenditures. The ageing population and prescribing practices seem to be the principal reasons for the increases in drug expenditures in Canada. This is the right time to reassess your action plan and priorities in order to consolidate India's position within the North American Pharmaceutical Industry. A hold up will result in falling out for the advantage other Asian competitors. Welcome to North America.

(The author is a QA/RA consultant for pharmaceutical & nutraceutical manufacturers and importers in Canada. Email: abapaz@yahoo.com)