 | « Back to article | Print this article |
The Canadian regulator Health Canada and Drug Control General of India (DCGI) would meet this week to discuss the Mutual Recognition Agreement (MRA) for the transfer of clinical data pertaining to drug safety, inspection of manufacturing sites and other quality control issues, said Supriya Sharma, director general, Therapeutics Directorate, Health Canada.
The proposed collaboration is good news for Indian generic drug exporters since Canada is the world's eighth-largest pharma market, accounting for prescription drug sales worth $18 billion a year.
Generics contribute about 45 per cent of the prescriptions, though it accounts for only 18 per cent of the sales, according to IMS Health data.
Talking to Business Standard on the sidelines of a seminar organised by the Institute of Clinical Research, in association with the Drug Information Association (DIA) and Biomedical Consulting International, Sharma said that co-operation would be extended for the regulation of medical devices and herbal products.
A delegation from Canada will also meet the health and commerce ministry officials to discuss further areas of co-operation.
"India has inherent strength in providing drugs at affordable costs and has immense know-how in process chemistry and development of generic products. The initiative is to facilitate trade of quality affordable drugs and pharmaceutical products between the two countries," she said.
The MRA will help in easing regulatory clearances for trade of drugs, pharmaceuticals and herbal products between the countries.
Health Canada would not insist on separate regulatory clearances for drugs and healthcare products imported to Canada, if the products were approved by agencies with which it has MRAs in place, she said.
Health Canada currently has MRAs with the drug regulatory agencies of the US (Food and Drug Administration), UK's Medicines and Healthcare products Regulatory Agency (MHRA), Switzerland, Australia, Singapore and China.
Health Canada will also sign MRA with the European Union's European Agency for the Evaluation of Medicinal Products (EMEA) during this month.
The drug business environment was beginning to favour generic drug sales and with the enactment of the new patent act in 2006, the evergreening of patents were restricted in Canada, Sharma summed up.
