Serious concerns are being raised over two Cabinet papers submitted by the Health Ministry with regard to the procurement of medications for Sri Lanka’s state sector.
Both Cabinet papers have been signed by Health Minister Dr. Ramesh Pathirana. The first dated July 23 deals with a proposed Government-to-Government (G2G) agreement with India to procure medications through HLL Lifecare Limited under the Indian government and Jan Aushadi Scheme of India. The second dated August 13 is for “direct contracting” for the procurement of 37 Essential Medicines.
Health Secretary Dr. Palitha Mahipala confirmed to the Sunday Times that the first paper had been passed by the Cabinet but not the second.
He said that no G2G agreement had been signed with the Indian government. Such an agreement would be signed in an emergency situation of a dire scarcity where Sri Lanka’s medicine requirement cannot be met, either through local production or the usual tender process. Sri Lanka would be assured of quality medicines through a G2G agreement with India.
There had been instances in the past when G2G agreements had been resorted to, said Dr. Mahipala, citing the securing of medicines from the Bangladeshi government several years ago. In case, Sri Lanka signs a G2G agreement with India, as stated in the Cabinet paper, a committee would be set up to identify what drugs would be secured.
He added that the Health Ministry is fully promoting the local production of medicines.
With regard to the second Cabinet paper, which seeks to carry out the “direct contracting method” for the procurement of 37 “essential” medications, the National Medicines Regulatory Authority (NMRA) Chief Executive Officer (CEO), Dr. Saveen Semage, said that there had been no tender participants for these drugs and some of them have been out of stock since January 2024 (this year).
This is why the Cabinet paper was submitted to allow the State Pharmaceuticals Corporation (SPC) to get direct quotations through a tender process from either the innovators of these pharmaceuticals or the World Health Organization (WHO) pre-qualified manufacturers who possess registrations with stringent regulatory authorities, as recommended by the NMRA, as required by the Medical Supplies Division (MSD). These direct quotations, if the proposal is passed by Cabinet, would not be restricted to one country but open to all.
The list of 37 drugs for this Cabinet memorandum had been provided by Dr. Semage along with the Health Ministry’s Deputy Director General (Medical Supplies), Dr. G. Wijesuriya.
Dr. Semage said that discussions with local suppliers and agents about two months back had resulted in registration being sought for two drugs on the list. They were for the treatment of heart and neurological conditions respectively – Digoxin injections 500mcg/2ml amp and Co-Careldopa tab. 25mg/100mg. The NMRA is in the process of registering them following protocol.
Assuring that the proposed direct contracting method would be for an interim period of about six months, Dr. Semage said that they were also looking into the possibility of implementing an “orphan-drugs pathway” to get these medicines. Sometimes no companies registered these drugs with the NMRA because they had to pay a registration fee and considering that the requirement maybe a small quantity, they did not think it was worth their while.
“So we have suggested the orphan-drugs pathway to give them the green light to bring in these drugs after scrupulously following our regulatory mechanisms but without paying a registration fee. This suggestion is being studied by the Legal Draftsman’s Department,” he added.
With regard to the first Cabinet paper, serious concerns from health sources were whether such a G2G agreement with India would give a death blow to the nascent local drug manufacturing companies which are now beginning to expand to fill a dire medicinal need of this country, while also providing jobs to Sri Lankans.
The ‘buy-back guarantee’ of the government with these local drug manufacturing companies, which have invested large amounts of money, is coming up for renewal this year, the Sunday Times understands.
Other issues included the introduction of the Indian Pharmacopoeia (IP) as a standard on par with the British and United States Pharmacopoeia which are currently adhered to by the NMRA. A pharmacopoeia is an official publication containing a list of medicinal drugs with their effects and directions for their use.
If there is a G2G agreement with India, will there be pressure to accept the Indian drug regulator’s decision rather than of the NMRA, many questioned, looking into a bleak future for Sri Lanka’s patients with the NMRA becoming redundant.
Another pointed out that India would be able to monopolize Sri Lanka’s drug supplies, thus wielding major power over this country. He asked whether it would also be the end of the open, competitive tender process.
In a letter dated August 27 to the NMRA on ‘Concerns regarding the Cabinet paper of Medicine Procurement from India’, theSri Lanka Chamber of the Pharmaceutical Industry (SLCPI) has expressed “deep concerns and our strongest opposition” , while reiterating that it would take whatever steps necessary to safeguard the rights of patients.
Arguing that the rationale being given by the authorities was the non-availability of a few products required for the state sector due to various reasons such as the absence of local agents and appointed agents being unwilling to import due to the small quantities required, the SLCPI suggests the “logical” solution of targeting such products individually and devising a method for procuring them as “Exceptions” mentioned in the NMRA Act of 2015 by obtaining waivers of registrations through the NMRA.
“Instead, the first proposal suggests a blanket importation strategy that covers the entire formulary and concentrates all purchases onto one company, HLL Lifecare Limited,” it states,
The SLCPI raises a “fundamental issue” – the document not mentioning “registration with NMRA”.
“The documents emphasize the acceptance of IP standards by the NMRA as a new step. As far as we are aware, the NMRA has long recognized IP standards. Moreover, a product bearing IP or any other standard on paper does not necessarily correspond to that standard – a fact that could only be verified by analysis, which the NMRA is currently unable to perform due to lack of an analytical laboratory,” states the SLCPI.
It adds: “The document mentions two entities, HLL Lifecare Limited and the Jan Aushadi Scheme of India, without explaining how they are interlinked. As far we know, HLL Lifecare Limited is not a renowned pharmaceutical manufacturer in India. We are sure the NMRA is aware that there have been approximately 115 quality failures of products during the recent past, 65 of which were due to Indian products. Given the serious nature of some adverse events, quality should be paramount in any procurement process.”
The suggestions of SLCPI include evaluation and registration of all medicines used in Sri Lanka by the NMRA, with exceptions allowed only in rare lifesaving and epidemic situations and even then, following the specific methodology laid down in the NMRA Act of 2015 by obtaining waivers of registrations through the NMRA.
By Kumudini Hettiarachchi The Sunday Times
While pointing out that India is not the only source of good quality, affordable medicines, the SLCPI requests the removal of blinkers and consideration of other countries in the region such as Pakistan, Bangladesh and even China