In a decision already drawing sharp criticism, the National Medicines Regulatory Authority (NMRA) has confirmed it will grant Waivers of Registration (WORs) for unregistered pharmaceutical products to be imported under the Government’s proposed Government-to-Government (G2G) procurement agreements.
The announcement has sparked fresh controversy within the pharmaceutical industry, rekindling concerns over regulatory bypasses and procurement scandals from previous administrations.
Responding to a question raised by The Sunday Morning, NMRA Chairman Dr. Ananda Wijewickrama explained: “If the product to be imported is unregistered, there is an established process. In the absence of registered suppliers, we carry out a rapid evaluation through an expert committee, and only after that is a WOR issued.”
He confirmed that this process would specifically apply to unregistered medicines intended for import under the upcoming G2G agreements.
A controversial history
The decision to issue WORs for unregistered pharmaceutical imports under the new G2G agreements has struck a particularly sensitive nerve, given the deeply controversial history of WOR issuance in Sri Lanka.
Between 2018 and mid-2023, the NMRA issued a staggering 1,601 WOR letters, bypassing the standard registration process designed to ensure the safety, efficacy, and fair pricing of medicines.
Originally meant for emergency situations – like life-threatening outbreaks or national crises – WORs were increasingly exploited for routine procurement, often without proper justification or oversight.
An audit by the National Audit Office (NAO) revealed that WORs were regularly issued to the same applicants, sometimes for the same medicines, while registered alternatives were readily available.
A fast-track Special Pathway was introduced in 2022, allowing WOR approvals on little more than purchase orders and invoices, sidelining essential evaluations of product quality, price fairness, and necessity.
The result was a flood of unvetted imports, some of which led to serious quality failures, recalls, and even fatalities, as in the tragic case involving bupivacaine in 2022. The controversy damaged public trust, weakened regulatory credibility, and prompted warnings from experts about the erosion of pharmaceutical standards.
NMRA stance
Against this backdrop, the NMRA’s move to resume WORs for G2G imports has reignited fears of history repeating itself.
However, explaining the NMRA’s process, Chairman Dr. Wijewickrama reaffirmed that the authority would adhere strictly to its established procedures, stating: “We will continue to follow the standard process with no exceptions.”
When asked whether all pharmaceutical companies would be required to have their products registered prior to importation, he clarified: “Not necessarily. Even now, our market includes both registered and unregistered products.”
Explaining the regulatory framework governing such imports, he said: “If a product is unregistered, there are clear regulations in place. Typically, in situations where no registered suppliers exist, we conduct a rapid evaluation through an expert committee. Only upon its recommendation would a WOR be granted, and this is not something done indiscriminately.”
Addressing whether this mechanism would mirror emergency procurement processes used in previous instances, Dr. Wijewickrama said: “Not exactly. This is not about bypassing protocol for speed; the issue is the absence of registered suppliers for certain medicines.”
He also stressed the authority’s primary responsibility, saying: “From the NMRA’s side, our absolute priority is to ensure that any product entering the country – registered or otherwise – meets the highest standards of safety.”
Govt. dismisses rumours
The pharmaceutical industry has warned of the potentially harmful impact the proposed medicine purchases under the G2G mechanism could have on patient safety, national economy, and survival of the local pharmaceutical manufacturing sector.
Health Minister Dr. Nalinda Jayatissa recently warned pharmaceutical suppliers to deliver medicines promptly, stating that the Government would directly procure medicines through G2G agreements if suppliers failed to comply. He announced plans to maintain a buffer stock sufficient for 3-6 months to prevent future shortages.
The Minister revealed that Sri Lanka was currently in discussions with seven countries to secure medicines through G2G deals. He also dismissed rumours about medicine shortages as attempts by vested interests to push for emergency imports at inflated prices.
Dr. Jayatissa acknowledged occasional shortages, attributing them to delays from past procurement orders, noting that it typically took around nine months for medicine consignments to arrive after placing orders. He confirmed that the country was currently receiving stocks ordered by the previous administration.
Industry bodies express concerns
Against such a backdrop, in a joint letter addressed to Health Minister Dr. Jayatissa, the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI), National Chamber of Pharmaceutical Manufacturers of Sri Lanka (NCPMSL), and Sri Lanka Pharmaceutical Manufacturers’ Association (SLPMA) expressed deep concern over the Government’s sudden decision to proceed with G2G imports without further engagement or follow-up discussions with local industry stakeholders.
This development follows an earlier initiative by the Ministry of Health, which brought together local pharmaceutical manufacturers, importers, and other stakeholders to address the shortage of 37 essential medicines required in Government hospitals. The industry welcomed those discussions but noted with disappointment that no subsequent meetings had been held to reaffirm or resolve the issue.
The industry bodies expressed alarm at media reports confirming the Government’s decision to import pharmaceutical products from various countries to address what they described as a purported medicine shortage.
According to the associations, this decision could have serious and far-reaching consequences. Chief among their concerns is the risk posed to patient safety due to the potential influx of substandard or unregulated medicines from unvetted foreign suppliers.
Furthermore, the industry warned of the threat this move posed to the domestic pharmaceutical manufacturing sector, which had been built up over decades and currently provided significant employment and investment within the country.
The letter further pointed out the economic implications of this decision, noting that increased dependency on imported medicines would result in substantial foreign exchange outflows and undermine the nation’s pharmaceutical capacity, especially during public health emergencies.
The industry also questioned the basis of the reported shortage, alleging that it may have been driven by misinformation and vested interests within official circles.
They claimed that certain officials had deliberately created artificial shortages by delaying procurement processes, stalling registration approvals for both importers and local manufacturers, and ignoring available stocks in order to justify the G2G procurement plan.
The associations expressed serious concern that the proposed G2G mechanism could dismantle the country’s existing, regulated supply chain and bypass established importers who were fully capable of ensuring a reliable supply of essential medicines, provided they received fair pricing and planned procurement schedules.
They further argued that if the G2G arrangement intended to comply with Sri Lanka’s stringent regulatory standards, any potential price advantage would likely be nullified, since reputable pharmaceutical manufacturers overseas already had licensed partners in Sri Lanka who could offer those products competitively.
Local manufacturers, in particular, stand to suffer severely from this move. Over the past decade, supported by Government policy, local pharmaceutical companies have made substantial investments in upgrading and expanding their manufacturing facilities.
The industry warned that these investments and the confidence built within the sector could be seriously undermined if their share of Government purchases was displaced by imports through opaque G2G agreements. Such marginalisation, they said, would affect employment, discourage investment, and erode national health security.
In addition to these operational and economic risks, the pharmaceutical bodies also flagged governance concerns. They stated that the proposed G2G arrangement contradicted recommendations by the International Monetary Fund (IMF), which emphasised the importance of strengthening local industries and maintaining transparent, competitive procurement processes.
The associations cautioned that bypassing established tender protocols could open avenues for large-scale corruption and undo years of regulatory improvements and capacity-building efforts in the sector.
The associations also argued that immediate solutions to the current medicine shortages existed within the country. Every product listed for import under the proposed initiative, they claimed, could be supplied either by existing registered importers or local manufacturers.
A transparent and competitive tender process, they emphasised, would ensure the timely supply of high-quality, registered medicines at reasonable prices, safeguarding public health, maintaining regulatory integrity, and supporting local industry.
In view of these concerns, the pharmaceutical industry leaders called for urgent intervention by the Minister of Health to immediately halt the proposed G2G import initiative, investigate any officials allegedly responsible for creating or exaggerating artificial shortages, fast-track pending registrations of already available medicines, and initiate transparent, inclusive dialogue with industry stakeholders.
Attempts to contact Health Ministry Secretary Dr. Anil Jasinghe and Medical Supplies Division Deputy Director General Dr. Lakshman Edirisinghe were unsuccessful.