India Should Work with Canadian pharmaceutical Regulatory Agencies to Encourage Investment in the country, say Experts

According to trade specialists, the Indian government wants Canadian regulatory agencies to recognise and commercialise pharmaceutical items in order to incentivize investment opportunities. According to industry analysts, "Health Canada's regulatory requirements for establishing and operating a pharmaceutical company are stringent." Administrative delays at the federal and provincial levels contribute to the lengthy schedule and high cost of new medications in Canada. In terms of value, Canada is the world's ninth largest pharmaceutical market.

The value of India's exports to Canada is USD 354.8 million. They account for around 1.82% of India's total pharmaceutical exports to the world, and formulations account for almost 80% of Canada's import basket." "By aligning its regulatory requirements with international practise, India should consider moving towards mutual recognition agreement (MRA)." This technique has also been followed in the India-UAE Comprehensive Economic Partnership Agreement (CEPA), which will significantly reduce transaction costs. This may shorten the time it takes for approvals. India may also propose lowering fees for permits based on mutual recognition or recognition from a reference regulatory authority. This is especially true for sophisticated pharmaceutical goods. The European Medicines Agency (EMA) is a regulatory authority that the Canadian government is likely to recognise for the purpose of recognition. India may also propose commercialization of products that have previously received regulatory approval in other regulated markets. Patented medicines largely dominate the Canadian pharmaceutical market due to a variety of reasons.

These reasons include the existence of smaller price differences between patented and generic drugs, stringent intellectual property protection for patented drugs, and the lack of uniform pricing for generic drugs across provincial markets, among others. Per capita spending on medicines in Canada is amongst the highest in the world, despite the existence of price controls. Notably, the Canadian government has made efforts to reduce the costs of medicines and increase availability of generics in the recent past. The drug review process in Canada involves the issuance of a ‘Notice of Compliance’ (NOC) and a ‘Drug Identification Number’ (DIN). The NOC permits the sponsor to market the drug in Canada and indicates the drug’s official approval.