• Severe institutional lapses revealed in quality, safety, and efficacy of distributed medicines  
• NMRA admits delays due to staff shortages 

A recent report by the National Audit Office for 2023 has revealed severe lapses in the National Medicines Regulatory Authority (NMRA) and the Medical Supplies Division (MSD) of the Ministry of Health, with regard to the quality, safety, and efficacy of the medicines provided to the public.

According to the said report, the NMRA, established under the NMRA Act, No. 05 of 2015, is tasked with ensuring the safety and quality of medicines. However, by the end of 2023, the Authority had failed to register over 1,500 medicines, leaving the relevant files incomplete. 

This backlog has resulted in extended registrations and batch release approvals that bypassed the legally-required evaluations for quality, safety, and efficacy. Under the relevant sections of the Act, every medicine submitted for registration must undergo quality testing at the National Medicines Quality Assurance Laboratory (NMQAL). 

The report noted that in 2023, 95% of the medicines submitted for registration lacked sample testing. This omission has resulted in the risk of substandard medicines entering the local market. The audit also revealed irregularities in the use of registration exemptions. Between 2022 and 2023, 287 exemption certificates were issued under the approval of the NMRA’s Chief Executive Officer without committee review or document verification. These exemptions, granted through a rapid ‘special pathway’, deviated from the systematic processes mandated by the Act, compromising transparency and patient safety, the report added.

The NMQAL was also found to have failed to obtain compliance-related certificates, implement recommendations from the Sri Lanka Accreditation Board and the World Health Organisation, and procure essential equipment. Additionally, a shortage of skilled staff left 337 quality inspections incomplete by the end of 2023. The report stated that these delays hindered the timely assurance of drug-related quality.

The report further stated that there have been weaknesses in planning and implementation within the MSD, poor communication with the State Pharmaceuticals Corporation, and supplier-related issues that led to shortages of 18 essential medicines. These shortages, according to the report, persisted for durations ranging from four months to nearly three years between December 2020 and November 2023.

In 2022, the health sector received a $ 200 million credit line from India to facilitate emergency drug procurement. Despite relaxed procurement guidelines, the audit found that emergency purchases have been conducted without adequate quality checks. Procurement decisions have been made through interest calling methods and unsolicited proposals, bypassing technical evaluation committees. The audit revealed that over Rs. 22 billion has been spent on 663 emergency procurements in 2022 and 2023. Monthly reports on these transactions have not been submitted to the Cabinet of Ministers for approval. Furthermore, the absence of proper verification mechanisms posed risks of substandard drugs entering the healthcare system.

The report brought to light several instances where substandard medicines caused harm to patients. For example, counterfeit versions of Human Immunoglobulin IV and Rituximab injections purchased for Rs. 144 million caused severe adverse reactions among patients. These drugs were later found to have been fraudulently supplied, with the supplier providing fake certificates and documents. Despite clear red flags, the report added that the evaluation committee has failed to verify the supplier’s credentials. 

In another instance, the drug Bupivacaine, used during surgeries, led to the death of one pregnant woman and life-threatening complications in another. The drug has been purchased for Rs. 40.74 million without proper evaluation or testing. By the time it was identified as substandard, the report added that 50% of the stock had already been used. Similarly, Prednisolone Acetate eye drops used after cataract surgeries caused severe infections and blindness in patients. Two individuals lost their vision completely, and 16 others developed infections. Despite prior warnings, the MSD and the NMRA had not implemented a mechanism to test the drug quality before distribution.

For over six years, the report stated that audits have warned the NMRA and the MSD about the need for a strong quality inspection mechanism before distributing drugs. Despite these warnings, the absence of effective action continues to allow substandard medicines to reach patients, added the report.

When contacted by The Daily Morning, NMRA Chairperson Dr. Ananda Wijewickrama said that the findings about delays within the NMRA were accurate. “The delays involve two main areas: Renewing drug registrations and registering new drugs. We have completed the renewals and expect to finish the registration of new drugs in the next few months.” 

He further said: “One of the problems was a lack of staff. This issue has now improved to some extent. Last year (2024), there were issues in hiring new staff, but the Health Minister and the Ministry have assured us that they will help with recruitment. With more staff, we are hopeful that there will be more progress in the coming months.”

Health Minister Dr. Nalinda Jayatissa was not available for comment.