Medical professionals oppose cabinet proposal to waive NMRA registration to import medicine

• We note that several of these drugs are not essential drugs and therefore, not necessary to import during this economic crisis. Some of these drugs are not even on the list of drugs purchased by the Ministry of Health
• They also noted that despite being classified as essential life-saving medicines, several drugs listed under those that must be imported are in no way as life-saving as being claimed

Leading medical organizations in Sri Lanka expressed their opposition to the cabinet’s proposal to waive NMRA registration in order to import medicines from a number of locally unregistered Indian providers through the Indian Credit line.

 The Councils of the Ceylon College of Physicians, College of Surgeons of Sri Lanka, Sri Lanka College of Obstetricians and Gynaecologists, and the Sri Lanka College of Paediatricians expressed concern in a letter dated January 27, 2023, regarding the request made to the board members of the NMRA and the Medicinal Evaluation Committee (MEC) to grant a waiver of registration for roughly 300 different types of medications that the Ministry of Health plans to purchase from Savorite Pharmaceuticals Ltd and others from the Indian credit line (ICL)under a cover of a cabinet decision.

 According to a press release issued by the NMRA, usually, before importing a drug, the NMRA has to evaluate and register it. However, for the last meeting of the Medicines Evaluation Committee (MEC) of the NMRA a list of about 330 drugs, each in large quantities, which are to be purchased through the Indian Credit Line, was submitted for approval and none of these were evaluated or registered by the NMRA.  “We were informed that the Chief Executive Officer of NMRA has approved about 275 of these by giving a waiver of registration without any check on quality, efficacy or safety of those drugs, to be used in government hospitals and sales through State Pharmaceutical Corporation outlets. We note that several of these drugs are not essential drugs and therefore, not necessary to import during this economic crisis. Some of these drugs are not even on the list of drugs purchased by the Ministry of Health. In addition to importation of these drugs for the Government hospitals, approval had been sought for some drugs for the importation by the State Pharmaceutical Corporation for the private market”, the statement read.

 Moreover, the NMRA states that the practice adopted recently approving drugs of which the quality, safety and efficacy are not assessed can put the lives of our patients in danger. Furthermore, this will lead to a waste of money as these will be purchased from a loan through the ICL which the people will have to repay. “We have raised this issue with the Chairman of the NMRA but with the lukewarm response we had, we have decided to write to His Excellency the President seeking his intervention”.

 Accordingly, Leading medical organizations in Sri Lanka have written to President Ranil Wickremesinghe to express their opposition to the cabinet’s proposal to waive NMRA registration in order to import medicines from a number of locally unregistered Indian providers through the ICL.
 The medical experts of the bodies said they are concerned about the possibility of sub-standard, non-evaluated medications being provided to public sector hospitals due to attempts by the officials of the Ministry of Health to obtain a non-evaluated registration waiver, contravening the recommendations of the President as the Minister of Finance when granting the cabinet approval for this process.

 They also noted that despite being classified as essential life-saving medicines, several drugs listed under those that must be imported are in no way as life-saving as being claimed.
 The attempts of the Ministry of Health to subvert the Finance Ministry directives as well as the move to import non-life-saving medicines falsely declaring them to be so and attempt to as well as asking for a ‘Waiver of Registration’ (WoR) for an antibiotics supplier from the company had multiple quality failures in injectable antibiotics, makes us question the bona fides of the Ministry of Health officials,” the bodies said.

  “We believe that the usual registration or purchase process can be carried out within a quick time frame to ensure quality, safety and cost-effectiveness of the medicines sought to be obtained from the said company,” they further added.
 The organizations urged the President to step in and compel the Ministry of Health to act in accordance with the NMRA Act and the procurement directives of the Finance Ministry in order to ensure process accountability and transparency and to guarantee a continuous supply of timely, high-quality, safe, and cost-effective medications to Sri Lankan hospitals.