Grave risk of substandard medicines entering market soon

Sri Lanka is facing an imminent threat in its health sector with high chances of substandard medicines like human immunoglobulin entering the market in the near future, as the law enforcement body of the National Medicines Regulatory Authority (NMRA) has diminished to just a single officer since this week.

 

In a shocking revelation the Daily Mirror learns that the NMRA Law Enforcement Division, which is supposed to run with a stipulated staff of at least 20 Food and Drug Inspectors attached to its head office, has been functioning with only two experienced officials for many months.

 

This figure has diminished to one since Monday, when the Chief Food and Drug Inspector of NMRA Law Enforcement Division also went on retirement, the Daily Mirror learns.

 

The NMRA, empowered by the National Medicines Regulatory Authority Act No.5 of 2015, is responsible of protecting and improving public health by ensuring medicinal products available in the country meet applicable standards of safety, quality and efficacy. The authority regulates medicines, medical devices, borderline products, clinical trials and cosmetics.

 

The role of NMRA as described under its Act is monitored by the authority’s Law Enforcement Division manned by its staff Food and Drug Inspectors.

 

The only remaining officer is also expected to complete his service by next June and go on retirement, thus the division is facing a crisis as the authority has not taken single measure to recruit new Food and Drug Inspectors or fill the remaining vacancies.

 

Although a scarce number of Food and Drug Inspectors are scattered in district level, the main regulation and coordination of drug raids, inspection tours on errant pharmacists and unlawful medicines manufacturers had been handled by the two remaining inspectors of the NMRA head office’s Law Enforcement Division.

 

The NMRA is governed by a seven member board headed by Dr. Ananda Wijewickreme and the attempts made to contact the Chairman of the board for comment were unsuccessful.

 

The NMRA Law Enforcement Division was chiefly responsible in carrying out the preliminary investigations of the human immunoglobulin scam that rocked the country, having a number of senior health sector officials sent behind bars including the former Health Minister Keheliya Rambukwella.