PCR and Antigen test kits imported by an unregistered company: Minister

 By Yohan Perera and Ajith Siriwardana   
PCR and rapid antigen test kits have been imported to Sri Lanka by a company which has not been registered with National Medicine Regulatory Authority (NMRA) during the COVID 19 pandemic period, Parliament was informed yesterday.  
Minister of Health Nalinda Jayatissa who was responding to an oral question raised by MP Rauff Hakeem in the House said, Divasa Pharma which has not been registered with NMRA has imported PCR and Antigen test kits worth Rs 2200 million.  
“Divasa Pharma is a company which belongs to another large entity which was highlighted in the news during the pandemic period. We will conduct an investigation into the matter and will inform Parliament details on it shortly,” he added.  
It was revealed that the government had borne a total amount of Rs 3,156,533,000 ( Rs 3.1 billion for rapid antigen tests while a sum of Rs 3,285, 678, 627 for PCR tests. A total sum of Rs 6,442, 211,627 for both test kits.  
It was further revealed that a total of 2,197,318 antigen tests 4.041,124 PCR tests had been carried out by the government while the private sector had carried out 618, 538 antigen tests and 2,641, 326 PCR tests had been carried out by the private sector. All these tests had been carried out from 2019 to 2022.    

In response to Minister Nalinda Jayatissa's statement made in parliament, George Steuart Health (Pvt) Limited issued the following statement: 

Divasa Pharma Limited, providing factual clarity on recent allegations made in parliament, says the company was issued a license to sell medicine by wholesale by the National Medicines Regulatory Authority (NMRA) on 18 August 2018, which has been continuously renewed to date.

Accordingly, Divasa Pharma Ltd has been a local authorized distributor of George Steuart Health (Pvt) Limited for some of its products, including COVID-19 PCR and RAT kits. As such, Divasa Pharma has legitimately marketed and sold COVID-19 PCR and RAT kits to the local market including to public healthcare institutions and
private healthcare institutions, under guidelines issued by the Ministry of Health.

These PCR and RAT Kits were sold at the NMRA stipulated price or less.

At no point has Divasa Pharma Ltd imported any PCR or RAT kits to Sri Lanka.

For public healthcare institutions, Divasa Pharma participated in a transparent tender procurement process, fullling all necessary requirements as a local authorized distributor of such products.

Divasa Pharma Ltd is a company incorporated in 2012. Divasa Pharma has valid NMRA and import licenses for the import and distribution of its own portfolio of pharmaceutical and diagnostic products. ese licenses have been obtained and renewed in keeping with all requirements of the NMRA.