In a shocking turn of events, the recent audit report issued by the Auditor General’s Department has laid bare a multitude of alleged irregularities in the procurement of medicines by the State Pharmaceuticals Corporation (SPC). This revelation has set off a firestorm of controversy in the medical supply sector.
The audit report has unearthed a series of concerning issues that have sent shockwaves throughout the healthcare community, leading to questions about the core principles of this critical industry. The revelations include the expiration of registration certificates, scrutiny of suppliers, and significant price discrepancies in the acquisition of essential medications.
The nine specific medicines under scrutiny are trastuzumab (440 mg) injections, ceftriaxone sodium for injection (BP 500 mg), diclofenac potassium tablets (50 mg), etoricoxib tablets (60 mg), cetirizine syrup (5 mg/5 ml), clonazepam tablets (0.5 mg), cefotaxime injection (USP 1 g), ipratropium pressurised inhalation (BP 20 Mcg/Puff), and furosemide injection (BP 20 mg/2 ml).
Trastuzumab: A shocking revelation
The procurement of 500 units of trastuzumab (440 mg) injections, valued at Rs. 26.225 million, had been marred by alarming irregularities.
The selected bidder had presented a registration certificate, purportedly issued by the National Medicines Regulatory Authority (NMRA), but this had not been a valid document from the NMRA. Instead, it had turned out to be a certificate issued by the Secretary to the State Ministry of Production, Supply, and Regulation of Pharmaceuticals, casting suspicion over the entire bidding process.
Furthermore, the provided registration certificate had expired. Astonishingly, the Ministry Procurement Committee had disregarded the Technical Evaluation Committee’s recommendation to award the contract to the lowest bidder, conditional upon the submission of a valid NMRA registration certificate.
Furosemide: A vaccine dilemma
Questions also surround the procurement of 5,845,000 units of furosemide injection (BP 20 mg/2 ml), valued at Rs. 35.76 million, spanning the years 2016 to 2018.
A concerning issue had emerged when 99,000 vaccine doses supplied to the Medical Supplies Division (MSD) had been deemed unacceptable. The supplier had responded with an Accelerated Stability Report, asserting compliance with required standards.
However, the audit had uncovered discrepancies, including differences in letterheads, the quality control manager’s signature, and the format of vaccine analysis certificates.
Disturbingly, the supplier had imported 3,898,900 doses of vaccines through two unregistered companies, raising questions about compliance with regulations. Tests by the National Medicines Quality Assurance Laboratory had revealed that the vaccines failed to meet British pharmaceutical specifications.
Although some stocks had already expired, State institutions were instructed to cease using these vaccines. A forensic audit had found that the manufacturer mentioned in procurement documents had no knowledge of the supply, raising further concerns.
Ceftriaxone sodium: The registration conundrum
Issues had also been unveiled in the procurement of 79,500 units of BP 500 mg ceftriaxone sodium for injection, costing Rs. 1.49 million.
These had included a supplier without a valid registration certificate, questionable import practices, and quality testing discrepancies, which had led to the withdrawal of some supplied stocks.
Shockingly, the supplier, despite significant concerns and a request for reimbursement due to non-compliance with specifications, was not blacklisted, and a substantial sum of Rs. 273.6 million was paid to the supplier in late 2022.
Diclofenac potassium: Delays and losses
The procurement process for 48,000 packaging units of diclofenac potassium tablets (50 mg) for State pharmacies had been plagued by delays.
The technical evaluation and procurement decisions had taken an astonishing 167 days to complete. The supplier’s registration with the NMRA had expired, taking an additional 258 days to renew, causing substantial delays in fulfilling the order. The delays have had severe consequences, resulting in significant financial losses for the corporation and a loss of Rs. 9.75 million in total sales.
Etoricoxib: Puzzling bidding decisions
The purchase of 30,000 packaging units of 60 mg etoricoxib tablets for State pharmacies had raised serious concerns.
The bid had been awarded to both the second and fifth lowest bidders, with 75% of the order allocated to the latter, despite their significantly higher price.
This puzzling decision had led to an additional cost of Rs. 6.2 million, deviating from the primary objective of providing medicines at the lowest possible price and causing a 329-day shortage, negatively impacting both the public’s access to essential medication and the corporation’s finances.
Cetirizine syrup: Lowest bidder ignored
A contentious decision had emerged regarding the purchase of 150,000 packaging units of the 5 mg/5 ml bottle of cetirizine syrup for State pharmacies.
The lowest bidder had been denied the contract, despite offering the lowest price and submitting a valid NMRA registration certificate, resulting in an additional cost of Rs. 6.06 million and a lack of stock at State pharmacies.
Clonazepam: Delays and financial implications
The procurement of 48,000 packs of clonazepam tablets (0.5 mg) for Rs. 20.07 million had faced significant issues and delays.
The protracted process had led to no sales for more than two consecutive months on six occasions, causing a loss of sales income for the corporation.
Cefotaxime: Puzzling negotiations
The procurement process for 250,000 vials of cefotaxime injection (USP 1 g) had been marred by perplexing decisions and irregularities.
Despite an initial cancellation, negotiations with a bidder who had initially offered a substantially higher price had resulted in an effective price increase of 774%.
Ipratropium: A lack of transparency
The procurement of 130,000 units of ipratropium pressurised inhalation BP 20 Mcg/Puff, valued at Rs. 91.70 million, had been riddled with perplexing events and irregularities.
These observations had revealed a concerning lack of transparency and accountability in the procurement process.
Raising concerns
In such a backdrop, Association of Health Professionals (AHP) President Ravi Kumudesh stressed that the audit report’s revelations on the medical procurement sector were deeply concerning.
“The irregularities, ranging from forged registration certificates to questionable price differentials, cast a shadow of doubt over the integrity of the procurement process. These issues not only raise ethical questions but also underscore the need for robust accountability measures and transparency in the acquisition of essential medicines,” he stressed.
The reported irregularities with specific medicines like trastuzumab and ipratropium are alarming and demand a thorough investigation. They not only jeopardised the availability of critical medications, but also eroded public trust in the healthcare system, Kumudesh said, adding that efficient and ethical procurement practices were essential to ensure that essential medicines reached those in need without being tainted by controversy.
It is imperative that the healthcare industry, policymakers, and the public join forces to institute reforms that promote transparency and uphold patient welfare.