“Indian Drugs Under Scrutiny in Sri Lanka After Adverse Events: What You Need to Know”

Imported Indian drugs under scrutiny in Sri Lanka following medical complications and fatalities

On June 16, 2023, local media in Sri Lanka reported the death of a patient undergoing treatment at the Peradeniya Teaching Hospital, in Kandy district, after being given the Indian-manufactured anaesthetic Bupivacaine. This incident came less than two months after a pregnant woman was reported dead at the same hospital, after being given an Indian anaesthetic drug. These incidents have sparked concern among locals and brought Indian drugs under sharp scrutiny within Sri Lanka.

Unregistered suppliers

Transparency International Sri Lanka had filed a fundamental rights petition in the Sri Lankan Supreme Court, challenging the decision of the Cabinet and health authorities to procure drugs from unregistered suppliers. The petition further questioned the national drug regulator’s role in providing a waiver of registration to allow for the swift import of essential drugs. Gujarat-based Savorite Pharmaceuticals (Pvt) Limited and Chennai-based Kausikh Therapeutics were named as respondents. Early in April, the Supreme Court granted leave to proceed in the case and suspended imports from these companies.

Visual impairment among patients

In May 2023, doctors at the general hospital in Nuwara Eliya, in Sri Lanka’s Central Province, reported complaints of visual impairment among 10 patients who were administered Indian medicines after eye surgery. The doctors cited the “presence of germs” in the eye medication as a reason for their patients’ condition. Health authorities initiated an inquiry and withdrew the drug to prevent further use.

India is top source

For years, India has been Sri Lanka’s top source of medical supplies, accounting for nearly half of its pharmaceutical imports that in 2022 totalled about $450 million. The trading link became more crucial in the wake of Sri Lanka’s unprecedented economic meltdown last year, that led to critical shortages, including medicines. The crisis-hit country continued procuring essential medical supplies from India, through the credit line offered by the Government of India, as part of its nearly $4 billion assistance to the island nation.

Inquiry ongoing

The death reported at the Sri Lankan hospital last week has brought the quality of imported drugs, as well as the responsibility of Sri Lanka’s national drug regulator, back to the national headlines. When contacted, Minister of Health Keheliya Rambukwella said that authorities were conducting tests, adding that a report was expected soon. Sri Lanka has been importing eye medication from the same Indian supplier for seven years, well before the Indian credit line came into effect, he said.

‘Two-fold health crisis’

Vinya Ariyaratne, president of the Sri Lanka Medical Association, said that these recent cases reflect a larger “two-fold” crisis facing Sri Lanka’s health sector: the persistent shortage of drugs on the one hand, and the serious concerns being raised about the quality of available drugs, on the other. The situation is “a national health emergency” requiring attention from the “highest levels”.

‘Weak regulation’

As for the apparent failure in quality control, the senior medical practitioner pointed to Sri Lanka’s “weak” regulatory system as the “main problem”. “The NMRA [National Medicines Regulatory Authority] is totally dysfunctional. The waiver of registration has allowed all sorts of medical procurements without any due process or accountability. We have to address this problem urgently if Sri Lanka is to have a proper supply of good quality drugs in at least six months’ time,” Dr. Ariyaratne said.

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