Life-or-death battle over drugs: Medical bodies go to President

The influential medical community’s battle against Health Ministry (MoH) moves to import drugs from locally-unregistered Indian suppliers—and to seek sweeping waivers of registration (WoR) from the National Medicines Regulatory Authority for hundreds of them—was escalated to the level of the President this week.

The Councils of the Ceylon College of Physicians (CCP), the College of Surgeons of Sri Lanka (CSSL), the Sri Lanka College of Obstetricians and Gynaecologists (SLCOG) and the Sri Lanka College of Paediatricians (SLCP) in a letter to President Ranil Wickremesinghe on Friday conveyed their “concerns and reservations” on the MoH’s request to the NMRA Board and its Medicinal Evaluation Committee (MEC) to bypass registration of around 300 varieties of medicines to be bought from India’s Savorite Pharmaceuticals (Pvt) Ltd and other companies through the Indian Credit Line “under a cover of a Cabinet decision”.

Last week, the Sri Lanka Medical Association, too, wrote to the President opposing

the move while the College of Physicians (CCP), the SLCP, CCP and the Sri Lanka Association of Clinical Pharmacology (SLACP) separately sent letters of protest to the NMRA Chairman. Now, the CSSL and SLCOG have joined the fight. The Sri Lanka Chamber of Pharmaceutical Industry (SLCPI) also earlier raised strong objections with the regulator.

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 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 WoR from NMRA for Savorite, without which its supplies cannot pass Customs. The medical bodies warn that this violates due legal process and endangers the lives of patients.

In their letter to President Wickremesinghe, the Colleges say they are very much concerned that “substandard, non-evaluated medications” will be supplied via public sector hospitals.

Requests from MoH Secretary and the Director of the Medical Supplies Division to offer a WoR to Savorite for 36 medicines were submitted to the NMRA Board, the letter states. A further list of 277 medicines was also sent by the NMRA Chief Executive Officer to the MEC, recommending WoRs.

This contravenes the President’s own directives—attached to the relevant Cabinet approval in his capacity as Finance Minister—that the prices and quality of medicines must be reviewed and that procedures applicable to private sector pharmaceutical suppliers be followed, the Colleges warn.

While the MoH Secretary maintains that lifesaving medicines are in short supply, “We wish to place on record that several of the medicines listed cannot in any reasonable sense be classified as lifesaving medicines”. Additionally, many can be procured from multiple NMRAregistered Indian suppliers. Hence, the Secretary’s statement is “factually flawed”.

The Colleges tell the President that the MoH’s attempts to “subvert” his directives, to import non-lifesaving drugs by “falsely declaring them to be so”, and to ask for WoRs for antibiotics from a company that had “multiple quality failures in injectable antibiotics” makes them question the bona fide of officials.

“We believe that the usual registration/purchase process can be carried out within a quick timeframe to ensure quality, safety and cost-effectiveness of the medicines sought to be obtained from the said company,” the letter says.

The Colleges ask President Wickremesinghe’s intervention to compel the MoH to act within the NMRA Act and the Finance Ministry’s procurement directives. They ask that their letter be tabled at the next Cabinet meeting.

In their missive to the head of the regulatory authority, the CSSL says the NMRA Act mandates that permission should only be given for WoRs in “special circumstances such as to save a life, to control and outbreak of an infection or an epidemic or any other national emergency or for national security to import and supply a particular medicine, medical device or borderline product in specified quantities”.

“However, we note that several of the drugs included in the list of drugs to be purchased from Savorite Pharmaceuticals are either non-essential or are available in sufficient quantities at the Medical Supplies Division (MSD) of the Ministry of Health at present,” it points out. “Therefore, provision of WoR for Savorite pharmaceuticals goes beyond the powers (ultra vires) provided by clause 109.”

The CSSL observes that the request to grant a WoR to Savorite was discussed without a full Board as many representatives (including its own) haven’t been appointed “for unknown reasons”. It is also understood that the matter was discussed “in a hurried manner in the latter part of the NMRA Board meeting, after discussing many ‘less important’ issues,” it states.

However, a proposal to grant WoRs for a long list of drugs from an unregistered company “should have been considered a very important issue and discussed at length, especially considering the fact that such a blanket WoR had never been granted in the history of NMRA”, CSSL asserts.

Unlike medicines donations received in times of shortage or distress, the buying of supplies using a loan facility that Sri Lankans must repay with interest “need to be assessed thoroughly prior to granting a WoR”. Considering the current economic crisis, the NMRA has a responsibility towards the Sri Lankan public to ensure a WoR isn’t issued “for the purchase of nonessential drugs and drugs which are in reasonable stocks at present”.

“Such actions could potentially lead to worsening of the economic crisis, for which the public may hold the NMRA at least partly responsible,” the CSSL cautions.