The Electric New Paper, 27 May 2008

GETTING a drug product licence is a stringent process.

Under the Medicines Act, a medicinal product must be approved by the Health Sciences Authority (HSA) before it can be sold in Singapore.

Scientific data must be submitted to substantiate the safety, efficacy and quality of the product.

All that is carefully reviewed before a product approval is granted, HSA deputy director Madam C Suwarin said. 'It can sometimes be a daunting amount of paperwork for us!'

Manufacturing plants are also subject to approval by HSA.

'But it is impossible to check every single one, every single time. So we use a risk-based auditing programme,' she said.

On-site audits and assessments are carried out periodically.

In the evaluation of a generic drug which contains the same active substance as the product originally developed by a drug company, HSA has to ensure it complies with quality standards.

For any prescription-only medicine in tablet and capsule form, a bio-equivalence study is required to prove that it is therapeutically equivalent to the original product.

A generic drug is considered to be bio-equivalent when the data obtained from it falls within the range of 80 per cent to 125 per cent of the original product.

'This is an internationally adopted standard by major agencies such as the US Food and Drug Administration and the European Medicines Agency,' said Madam Suwarin.

About 20 per cent of generic products on the register here are manufactured locally, while the remaining are imported.

'Sources of imported generic products include countries like Malaysia, Thailand, Korea, India , Canada , USA and Australia,' said Madam Suwarin.

And even though some Asian countries have a big problem with illegal or counterfeit drugs, they also have some excellent makers of generic drugs.

'The regulatory system that we have put in place and the easily accessible medicinal products helps to ensure that the problem of poor quality or counterfeit products remain outside the legitimate supply chain,' she said.
 

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