Caribbean-wide drug regulatory system 'will help fight fakes'

Drug counterfeiters may find it harder to get their fakes into the Caribbean after the establishment of a regulatory system designed to boost conditions for safe, high-quality drugs in the region.

Set up by the Caribbean Public Health Agency (CARPHA), in collaboration with CARICOM (the Caribbean Community Secretariat of 20 countries) and the World Health Organization/Pan American Health Organization, the new CRS will strengthen regulatory capacity and focus on providing regulatory assurance to essential generic medicines for the region and co-ordinate pharmacovigilance.

"Access to safe, efficacious and good-quality drugs is a human right, which CARPHA as the regional public health organisation is committed to facilitating," said Dr James Hospedales, executive director of CARPHA.

"Through the CRS, CARPHA will be able to help countries perform functions such as reviewing, approving and monitoring medicines in a timely manner, allowing patients faster access to quality drugs."

The CRS, which has received funding from the Bill and Melinda Gates Foundation, will provide registration, product reviews and pharmacovigilance support to CARICOM member states and will streamline regulatory efficiencies for the resource-constrained smaller states.

CARPHA believes the new regulatory system, which will coordinate safety and quality reporting with CARICOM, will reduce the cost of medicines to both consumers and the health system and will also improve accessibility and affordability.

From an industry point of view, the CRS offers a central portal for access to CARICOM's market of more than 17 million people alongside a streamlined set of requirements and accelerated procedures.

In the past, the Caribbean has had a limited framework for medicine regulation, with poor capacity in core regulatory functions, inadequate legislation and resource constraints. Just five CARICOM countries currently conduct safety, quality and efficacy reviews on drugs.

The lack of oversight has led to concerns around the presence of counterfeit and substandard drugs in the region, with some reports suggesting the counterfeit market share could be as much as 30per cent.

A Caribbean news report at the end of last year, quoted a GlaxoSmithKline counterfeit expert claiming that Haiti, Trinidad and Jamaica were believed to be the region's biggest importers of fake drugs from India, while South American country Guyana (often included as part of the Caribbean) was seen as a transhipment point for fake drugs coming out of Brazil.

Much of the bogus drugs in the region stem from white collar crime through corruption and greed but with crackdowns on illicit drugs in South America many narco gang lords have shifted to fake pharmaceuticals where regulations have proved to be more lax in developing countries.

As the issue of counterfeit drugs has become more prominent, the need for an improved regulatory system has been evident and commentators have increasingly discussed this. In 2011, initial plans for the CRS initiative were voiced.

Now it is hoped the new CRS, which aims to augment and support the already established national regulatory authorities, will address many of the concerns and improve the quality of the pharmaceuticals in the region.

Farz Khan, chief chemist and director, chemistry food and drugs, Ministry of Health, Trinidad and Tobago, said the CRS would play a significant regulatory role. "There is a need to support all areas of medicine regulation, ensuring that local assessment and registration processes are based on international best practices, harmonised requirement and guidelines," he said.