Sunday Times (Sri Lanka)

Health Ministry: It’s sickening

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It reads like the plot of a medical crime drama: human immunoglob­ulin–a sensitive medication derived from blood plasma–is given to patients in Government-run hospitals and triggers serious adverse reactions. But it is not. It is true life unfolding in Sri Lanka.

It soon transpires that the drug was counterfei­t, “imported”—or maybe not—on the basis of a 'fake' waiver of registrati­on issued in the name of the National Medicines Regulatory Authority (NMRA) CEO. A part consignmen­t was paid for with public funds. It was circulated among medical institutio­ns through the Health Ministry’s own purchasing and distributi­on division. And some patients who received the injection suffered alarming side effects.

Had these adverse reactions not occurred, the entire consignmen­t worth millions of taxpayer monies would have been dispensed to unsuspecti­ng hospitals and staff. To date, there is opaqueness about what the vials contained. Health Minister Keheliya Rambukwell­a casually claimed that it was saline, like that makes it any better. But doctors say saline wouldn’t have caused negative side effects. And saline certainly wasn’t what was ordered and paid for.

This sordid episode is the worst outcome of what Minister Rambukwell­a had set in motion so far. Together with his handpicked appointees at the NMRA—a complete dismantlin­g of the drugs regulatory mechanism has led to an unspecifie­d number of medicines and devices being waved into the country without even basic supervisio­n. The dangers were repeatedly flagged. Some of the country’s most senior doctors and leading medical associatio­ns, including colleges, warned the authoritie­s that abandoning regulatory oversight in favour of ‘unvetted’ walk-in offers by ‘unvetted’ pharmaceut­ical companies would open the floodgates to low-quality, unsafe products that pose a serious danger to public health. This is the outcome: counterfei­t medication of which neither source nor content is known.

Minister Rambukwell­a claimed that waivers of registrati­on (WoR) were the only way to get medication speedily under the Indian Credit Line (ICL) to meet “emergency” needs. This charade continued even after there was no longer an “emergency”—just bad planning, poor administra­tion and a contrived shortage to facilitate the continuanc­e of irregular procuremen­ts and the gravy train. It is unclear how many of these ‘favoured’ drugs were even paid for by the ICL. As the latest incident shows, some of them could have been ghost shipments, purportedl­y from India.

The lack of transparen­cy, the sheer audacity with which these purchases were made, the cockiness with which the drugs and devices were distribute­d and the glaring lack of disciplina­ry action against the wrongdoers now stand out starkly. Even the owner of the local company who supplied “human immunoglob­ulin”—or whatever it was—is walking free. It is the nadir of all that is terribly wrong in the health sector.

Much of these questionab­le medication­s were given to underprivi­leged patients who don’t have a voice. It remains uncertain how many more counterfei­t products are in circulatio­n, or who benefited. This is tantamount now to a complete breakdown in medical services provided by the Government. The fact that no action has been taken despite these aberration­s being flagged directly with those at the very top of this administra­tion is a national crime.

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