Medical bodies say Health Ministry’s new Indian purchases could endanger livesView(s):
By Namini Wijedasa
Four of Sri Lanka’s most influential medical bodies have sent strong letters of protest against Health Ministry moves to import drugs from locally-unregistered Indian suppliers, saying it violates due legal process and endangers the lives of patients.
The Cabinet recently sanctioned a proposal by Health Minister Keheliya Rambukwella to use the Indian credit line to buy medical supplies–without competitive tender–from a handpicked, locally unregistered Indian manufacturer named Savorite Pharmaceuticals (Pvt) Ltd despite there being multiple authorised suppliers holding valid National Medicines Regulatory Authority (NMRA) registration.
It was also proposed to entertain an unsolicited proposal from a second Indian entity named Kausikh Therapeutics (P) Ltd. The Health Ministry has already applied for a “waiver of registration” (WoR) from NMRA for Savorite, without which its supplies cannot be cleared through Customs.
The Sri Lanka Medical Association (SLMA) this week wrote to President Ranil Wickremesinghe opposing the move. Separately, the Ceylon College of Physicians (CCP), the Sri Lanka College of Paediatricians (SLCP) and the Sri Lanka Association of Clinical Pharmacology (SLACP) have all sent written protest letters to the NMRA Chairman.
Meanwhile, at the NMRA Board meeting held on Friday, representatives of the CCP and SLCP personally objected to any decision to waive registration and also handed over individual letters of protest. (The Minister is yet to appoint the nominee of the College of Surgeons to the NMRA Board).
The NMRA only issues WoRs for essential medicines for which there are no registered suppliers in Sri Lanka, SLMA, the umbrella body of doctors, holds.
Pointing to the Health Minister’s request–and the NMRA’s decision to issue a waiver for Savorite’s products–the SLMA says, “These are serious irregularities that can endanger the lives of patients and are unethical violations of due process.”
As none of Savorite’s products are NMRA-registered, there is no assurance of the quality, safety and efficacy of these medicines. This also compromises the integrity of the registration certificate issued by the NMRA for other drugs and consumables, the SLMA points out. It appears that the suppliers “have been selected violating the due legal process as they are not registered with the NMRA”.
“Contrary to what has been conveyed to the Cabinet, both lists [Savorite’s and Kausikh’s] include several non-essential medicines,” the SLMA maintains. “By giving WoR, the NMRA has allowed these to be imported to the country using a loan facility when many essential medicines are not available.”
Meanwhile, some of the ordered medications are already available in “reasonable stocks” at the Health Ministry’s Medical Supplies Division. This meant it was not necessary to bypass the usual tender procedure.
The other associations, too, observe that many of the medicines for which the Health Ministry waivers were non-essential, although Cabinet approval was obtained citing the opposite.
“The Secretary to the Ministry of Health states in his letter that lifesaving medicines are in short supply,” the CCP states. “Please note that some of the medicines listed to be purchased such as Montelukast, Fisateride, Mometasone cream, Mupirocin cream, and Pregabalin cannot in any reasonable sense be classified as lifesaving medicines.” The SLCP maintains the same.
The SLMA has requested President Wickremesinghe to “immediately stop the proposed procurement by the Health Ministry; to initiate a prompt and impartial inquiry into “how distorted facts were communicated to the Cabinet in the two Cabinet papers referred to in this letter”; and to direct the Health Ministry to expedite the existing mechanisms to purchase medicines, confining it to the procurement of essential supplies.
The CCP conveys its “concern and reservations” to the NMRA Chairman about the request placed before the regulator’s Board to provide WoRs for medicines from Savorite.
“The legal counsel advising the CCP has informed us that Section 109 of the NMRA Act of 2015 lays down provisions relevant to waivers of registration,” the College says. “Please note that the Minister of Health or any other official from the Ministry of Health has NO [SIC] authority to direct the NMRA to provide a waiver of registration but can only make a request to the effect.”
Provision of waiver is at the Board’s discretion and Board members–the CCP is also represented on it–are legally liable (under the Penal Code and the Bribery Act) for decisions made, the CCP points out. Violations, if proven, carry heavy penalties and lengthy jail terms.
Consequently, the CCP has advised its representative on the NMRA Board, Dr. Pradeep Kumarasinghe De Silva, “to oppose the request to grant a waiver of registration to this unsolicited proposal from Savorite Pharmaceuticals”.
“We have also advised him to obtain from NMRA a document trail to confirm that he was not complicit to any irregular decisions taken by NMRA Board and the will not hold any collective responsibility and will bring this fact to the attention of the judiciary in a subsequent litigation process,” the CCP tells the NMRA Chairman.
The SLCP has addressed a similar letter as the CCP to the NMRA Chairman. Its representative, Dr. Kosala Karunaratne, has been given the same legal advice as the CCP nominee. Both bodies say they believe “the formal registration process can be carried out within a quick timeframe to ensure quality, safety, and cost-effectiveness of the medicines sought to be obtained from Savorite Pharmaceuticals”.
The SLACP expressed its serious concern to the NMRA Chairman about granting WoRs outside the standard procedure as it can have a negative impact on public health. Earlier, the Sri Lanka Chamber of Pharmaceutical Industry (SLCPI) also raised strong objections with the regulator.
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