THE approval process of sub-standard and low-quality medicines has long been debated in Pakistan.

A research paper published in the Journal of Pharmaceutical Policy and Practice asserted that there is negligible scientific data available on the issue of medicine quality in Pakistan, and “the anticipated number of 40-50 per cent of poor-quality drugs in Pakistan cannot be defended by data”.

These results show that the system for drug approval in Pakistan is ineffective and has massive loopholes.

On the contrary, the drug approval system in Australia is praised by the United Nations Office on Drugs and Crime, and is considered one of the most effective systems across the globe.

The procedure follows an in-depth evaluation of the medicine before allowing it to be promoted or marketed.

The government is also involved in setting the price for the latest product. The drug, in order to get approval, has to undergo a thorough process called ‘evidence-based procedure’ under which the pharmaceutical company has to provide evidence to support its assertions on the comparative improvement in the latest product over the existing ones.

The system in Autralia is one of the most well-structured way of improving the quality of drugs that are approved for use in the market. The Drug Regulatory Authority of Pakistan (Drap) has to put in place proper professional procedures before providing approval to any pharmaceutical product to be marketed in order to improve quality of medicines.

Sami Sahil Baloch
Nokkundi

Published in Dawn, July 28th, 2021