• NMRA rejects allegation, says Health Ministry sets diagnostic test prices

The price controls imposed by the National Medicines Regulatory Authority (NMRA) have prevented private hospitals from using high-quality reagents for laboratory tests, raising concerns over the quality of laboratory reports and patient safety, President of the Medical and Civil Rights Professional Association of Doctors (MCPA), Dr Chamal Sanjeewa alleged.

Speaking to The Daily Morning on the need for urgent reforms to the country's medicine regulatory system, he said yesterday (2) that the restrictions had affected the ability of private hospitals to conduct tests using high-quality reagents.

He alleged that this had led to a decline in the quality of laboratory reports issued by some institutions and warned that inaccurate reports could result in misdiagnoses and serious consequences for patients.

Dr Sanjeewa said several reforms were needed to strengthen the medicine regulatory system, including the introduction of a transparent online tracking system that would allow the public to monitor the progress of medicine registrations and approvals.

He also proposed a fast-track approval process for medicines that have already been cleared by internationally recognised regulatory authorities such as the World Health Organization (WHO) and the United States Food and Drug Administration (US FDA).

The MCPA President further called for the establishment of a WHO-standard laboratory to test every imported batch of medicines before they are released to the market, saying this would help ensure the quality of medicines entering the country.

He also stressed the need for stronger market surveillance through regular inspections to prevent the circulation of substandard medicines, while calling for a scientific pricing formula that takes into account global medicine prices and fluctuations in the US dollar exchange rate.

The NMRA regulates the registration, licensing, importation and control of medicines and medical devices in Sri Lanka, with the stated objective of ensuring public access to quality-assured medical products.

However, NMRA Chairperson Dr Ananda Wijewickrema dismissed the allegations, describing the claim that NMRA price controls had prevented private hospitals from using high-quality reagents as false.

He said that where price controls existed, they had been imposed by the Ministry of Health on certain diagnostic tests, not by the NMRA.

Attempts to contact Deputy Minister of Health Dr Hansaka Wijemuni for comment were unsuccessful at the time of publication.