The withdrawal of two pharmaceuticals imported from India, following two recent incidents reported from the Peradeniya Teaching Hospital and the National Eye Hospital, has cast doubt over the quality of other medicines that have been sourced via the Indian Line of Credit (LoC) facility.  

Both pharmaceuticals that have been imported to Sri Lanka recently from Indian manufacturers had been ordered by the State Pharmaceuticals Corporation (SPC) at the time of the economic crisis, during which the SPC relied on Indian and other credit lines and funding from multinational agencies to import medicines which were in short supply. 

In this background, medical experts last week stressed the need for a sophisticated national testing facility to check the quality of imported pharmaceuticals. 

It was reported on 2 April that a pregnant woman who had been admitted to the Peradeniya Teaching Hospital for a caesarean surgery had allegedly died of complications after being administered a certain medication. 

Following the incident, the Health Ministry suspended and withdrew the medication which had caused complications and a team of experts were sent to the Peradeniya Teaching Hospital to investigate the matter. The Medical Supplies Division (MSD) temporarily withdrew the use of three categories of anaesthetic medication used for surgeries in Sri Lanka.

Again, on 14 April, the National Eye Hospital suspended surgeries with immediate effect following reports of several incidents of infections in patients who had undergone surgeries.

Reports indicate that primary investigations have revealed that the infections were allegedly related to an eye drop, namely prednisolone, imported from India under the Indian credit line.

The particular batch of medicine has been withdrawn from the hospitals.

In such a backdrop, questions have been raised about the reliability and quality of the medicines brought down to Sri Lanka from India under the Indian credit line.

According to the Health Ministry, over 300 types of medicines are scheduled to be imported to Sri Lanka from India under the Indian credit line during March; earlier, it was said that around 122 types were scheduled to be imported.

Association of Health Professionals (AHP) President Ravi Kumudesh, commenting on the issue, alleged 80% of the medicines imported to Sri Lanka under the Indian credit assistance system had not been registered.

Matter before courts

Meanwhile, on 6 April, the Supreme Court temporarily suspended the importation of Indian pharmaceuticals under its credit line until a further court order, amid concerns over quality and safety as well as questions over the legality of the procurement.

The Supreme Court granted leave to proceed in the Fundamental Rights petition filed by Transparency International Sri Lanka (TISL), which raised serious doubts regarding the quality, safety, and efficacy of the pharmaceuticals purchased under the Indian credit line.

The Supreme Court ordered the suspension of further importation of pharmaceuticals without obtaining a further order from the court after proving the quality, safety requirements, and the legality of the procurement.

The court also ordered the release of two consignments that have already reached Sri Lanka for consumption “only after conducting necessary tests, and the NMRA expressing its independent decision assuring the safety, quality, and efficacy of the already imported pharmaceuticals,” as per the TISL.

The petition was filed against steps taken by the Cabinet of Ministers, the Minister of Health, the Ministry of Health, and the National Medicines Regulatory Authority (NMRA) to procure medical supplies from two private Indian companies – Gujarat-based Savorite Pharmaceuticals (Pvt) Ltd. and Chennai-based Kausikh Therapeutics (P) Ltd.

The petition has mainly questioned the role of the Cabinet of Ministers in procuring medical supplies through unregistered private suppliers, the role of the NMRA in providing a waiver of registration to procure medical supplies from unregistered suppliers, non-compliance with procurement guidelines including the emergency procurement process, and abuse of process by the Minister of Health and the Chief Executive Officer of the NMRA.

The waiver of registration is required to clear the imported medicines through Customs.

Quality testing required to ensure safety 

According to the Health Ministry, the earlier medicine shortage has been resolved with a shortage of 169 types of medicines reduced to 119 and all 14 life-saving medicines made available at hospitals.

Raising concerns over the quality assurance of the medicines that are imported to the country, the Government Medical Officers’ Association (GMOA) stressed that all medicines should be tested for quality within the country and laboratory facilities should be made available to facilitate the process so as to ensure the safety of the patients.

Speaking to The Sunday Morning, GMOA Spokesman Dr. Chamil Wijesinghe said: “Ideally, the country should have a sophisticated lab to check each and every type of medicine that is imported, but at present, we don’t have such a lab to test medicines. There was a budget proposal in 2009 and recently there was another proposal. We also proposed this in our tenfold proposal submitted to resolve the medicine issue. There should be a permanent solution to resolve this issue.”

“Usually, investigations are carried out only when we find a case of an abnormality. These are the two incidents that have been reported up to now,” Dr. Wijesinghe shared, adding that other than the two recent incidents, there had been no complaints. “However, that doesn’t mean that everything is perfect,” he added.

Inevitable situation 

Speaking to The Sunday Morning, Association of Medical Specialists (AMS) President Dr. Lakkumar Fernando said that these incidents were expected and were a result of not following a proper evaluation process prior to ordering the medicines. 

“We periodically receive circulars from the Ministry of Health, since they source medicines from various sources and after a while find out that the medicines are not working or that there are adverse effects, whereupon the medicines are withdrawn. This is a well-known phenomenon that has continued for decades. Following the setting up of the NMRA, registration became more streamlined and such incidents became very rare,” he said.

“These medicines were imported suddenly and I don’t think that they went through a proper evaluation process. This is an expected result of such a system where things had to be imported in a hurry,” Dr. Fernando said, urging the authorities to ensure the quality of medicines that had to be imported.

Moreover, he urged the public to remain vigilant and to purchase medicines from reliable authorities. 

When contacted, former President of the AMS and Consultant Paediatric Orthopaedic Surgeon Dr. Sunil Wijayasinghe said that there were established regulations within the NMRA related to importing medicines to Sri Lanka and that those regulations were in place to ensure the safety of patients. “If you try to violate these regulations, these things can happen,” he noted.

NMRA response 

When contacted, NMRA Food and Medicines Inspection and Legal Action Division Head Amith Perera said the National Medicines Quality Assurance Laboratory was situated within the NMRA premises and that pre-market and post-market samples were continuously checked by lab technicians. 

“We don’t test all medicinal drugs. No drug authority would test all the drugs that are imported to a country. Before sending the consignment, the manufacturer usually sends an analytical report from an independent lab. This does not happen for every consignment, but for specific products, such types of documents are needed. 

“There are so many procedures to ensure the quality of the product. We collect samples from the market or at the port after clearing the samples. Depending on the location and risk involved with that product, we collect samples and test at our laboratory,” he explained. 

When asked whether every drug imported to the country was tested, Perera said that the product quality could be assured for some drugs that were not sensitive and that the quality of other drugs were checked regularly. 

Highlighting the two recent incidents, Perera stressed that no market sample could be collected for prednisolone as the product was unavailable in the market at present. The entire consignment has been withdrawn by the MSD. 

“We contacted the manufacturers and asked for explanations. Usually, they keep the remaining samples in the warehouses. We can ask for explanations through the Indian drug authority,” he added. 

He added that reactions to any drug depended on the nature of the patient or the consumer. 

“With every reaction to a drug, we can’t always say that it is a quality failure. Many chemicals such as additives, stabilisers, and preservatives are used in medicinal drugs. Drugs are called small poisons. Reactions may happen at any time; we can’t say that such incidents are a result of a quality failure. To prove it, we have to investigate. It is only after investigations that we can determine whether it is a quality failure or due to the sensitivity of the consumer,” he explained. 

When asked whether the drugs coming from India under the Indian credit line were being tested, Perera said: “Not every product is being tested; only suspicious products are being checked by lab technicians.”