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The Pharmaceuticals Market in Sri Lanka: Ending the Chaos

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By Dr. Dayanath Jayasuriya, President’s Counsel

In 1949 whist debating the Food and Drugs Bill, Dr. N. M. Perera stated, with almost prophetic vision, that “there has been all sorts of muck, if you will permit the use of the word, labeled under the name of drugs in this country.”

More than 70 years later these words are equally true if one were to look at what is available in some places – drugs banned even in the country of origin, expired drugs, drugs in relabeled packages, drugs unregistered with the regulatory authority, drugs of dubious quality, drugs the importation of which specialist committees have cautioned against and drugs from certain manufacturers not known for good quality production facilities.

The list can be much longer. Public sector hospital pharmacies lack even some of the basic essential medicines. In-patients are asked to bring with them cotton wool to surgical equipment if planned surgeries are to take place. Daily qualified specialists as well as young doctors leave the country in search of greener pastures.

From the late 1950s and early 1960s onward Sri Lanka gradually developed a system for the regulation of pharmaceutical products. Initial efforts were due to the singularly impressive work of Professor Senaka Bibile who developed a hospital formulary to rationalize the availability of drugs in the hospitals. Later during his tenure as the founder Chairman of the State Pharmaceuticals Corporation, he found good and relatively inexpensive sources to partially satisfy the country’s demand for imported drugs.

With trade liberalization in 1978, there was an exponential increase in the number and type of medicines that flowed into the country.

In 1980, Sri Lanka enacted the Cosmetics, Devices and Drugs Act. It was based on the Canadian regulatory system. Provisions in the Act and regulations that were enacted five years later provided the basic model of legislation required for developing countries (see, further, D. C. Jayasuriya, Regulation of Pharmaceuticals in Developing Countries: Legal issues and Approaches, WHO, Geneva, 1985). As the country gradually progressed with the expansion of the health-care system, the Act required further amendments but many years later an ill-advised measure was taken to repeal it lock, stock and barrel.

In early 2005 I published a 156 page book entitled Towards a National Drug Policy: Sri Lankan Perspectives. Its nine chapters enumerated measures to be taken based on good practices.

During the drafting of the National Medicines Regulatory Authority Bill, which later became an Act of Parliament (No. 5 of 2015), various groups lobbying to dilute its clauses were very much active. A few professionals posing as independent consultants or experts either lacked expertise in legal drafting or clearly had conflicts of interest. The strongest lobby was for the exclusion of cosmetics from the purview of the legislation, opening the flood gates to import all kinds of products at great cost to the country.

In 2015, a National Medicinal Drug Policy for Sri Lanka was adopted. Its Preamble stated that “Sri Lanka had a partly written Drug policy from the 1960s. It was “written” as elements of a policy, beginning from selection of drugs for the government drug supply and the Ceylon Hospitals formulary in early 1960s, the Bibile-Wickremasinghe report in 1971, the Cosmetics Devices and Drugs Act (1980). However, there was no comprehensive document. There were attempts to develop a NMDP in 1991 & 1996; while the documents were accepted by the Ministry of Health, they did not reach the final step of cabinet approval.” The Policy stated as follows:

A National Standing Committee will be appointed by the Ministry on the recommendation of the Director General of Health Services, comprising all stakeholders to oversee the implementation of the National Medicinal Drug Policy (NMDP).

The Essential Medicines List will prioritize the medicines that are important. The medicines will be selected according to valid scientific evidence, the disease pattern in the country and cost-effectiveness. A standing committee comprising all stakeholders will be established to define and regularly update the National Essential Medicines List. It will formulate, review and update Standard Treatment Guidelines, Drug Index, the Sri Lankan Formulary and Government Drug procurement Documents.

A pricing policy/ mechanism should be adopted to ensure affordability. Retail pricing should be based on a dispensing fee rather than cost markup. Legislation requiring generic prescribing and allowing cost effective generic substitution with the consent of the patient (and where possible informing the doctor) should be enacted.

The state should provide sufficient funding for procurement and supply of necessary medicines with priority for essential medicines, monitor appropriate use and prevent waste. Public and private sector health insurance schemes will be encouraged to develop reimbursable lists of medicines.

The responsibility for ensuring a continuous availability of Essential Medicines in the country is a shared public/private sector responsibility. The state should continue centralized bulk purchase and supply to its institutions. Preference should be given to local manufacturers in supply of medicines to the state sector. Good pharmaceutical procurement practices and management of the supply chain should be enacted for both the public and private sector. There should be a private/public mix of suppliers to the private sector

The regulatory authority should have transparent mechanisms and adequate human resources. Medicines should be registered based on the criteria of quality, safety, efficacy, need and cost effectiveness. An accredited drug quality Assurance Laboratory should function within the authority with appropriate fees for services keeping with WHO Good Clinical Practice Guidelines.

Once the NMDP is adopted, it will be the responsibility of the Minister of Health on the recommendation of the Director General of Health Services, to appoint the National Standing Committee within three months to oversee the implementation of the policy. This policy will be reviewed, and revised if necessary, in five years.

A few months ago guidelines were issued on the tender process for drug procurement. Work on this commenced in 2004 when I was a founder director of the National Procurement Agency set up by the then President HE Chandrika Bandaranaike Kumaratunga.

Quality control problems with a few drugs manufactured in India have been well documented in the past but what is of concern is that still reports appear.

For instance, The Washington Post of April 4, 2023 had an analysis entitled ‘Just How Dangerous Are India’s Generic Drugs?’ The commentator noted: “For a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight. In the last six months alone, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated. The children who died — mostly under the age of five years — were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts.

The eye drops contained extensively drug-resistant bacteria. So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed, some went blind, the Centers for Disease Control and Prevention reported on March 21. The Indian company issued a voluntary nationwide recall for the drops.

The Wall Street Journal of June 19, 2023 reported that drug shortages stem from quality problems in Indian factories; eye drops, chemotherapy drugs raise concerns about generic products.

Whilst Sri Lankans have to be thankful to India for a generous credit line to import drugs, importation must be done in a structured manner under the oversight of qualified medical specialists.

The priority now is to rapidly compile an inventory of all drugs available in Sri Lanka. Pharmacies must be under a strict legal obligation to provide within a stipulated time-frame material information of the drugs in stock and new drugs on order. Non-compliance must be severely dealt with without fear or favour. Bespoken software is available to systematically enter the data and then to rationalize by an expert committee through a scientific and transparent process what is needed and how gaps need to be met. Otherwise, Sri Lanka will soon become just another junk yard of unwanted and hazardous drugs, negating all the gains from the time of Bibile and other trail-blazers who did their best to ensure that Sri Lanka has one of the best drug regulatory and health-care systems in the developing world.

(The author has advised more than three dozen countries on drug regulatory issues and has published four books and over 50 articles on the subject).



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Misinterpreting President Dissanayake on National Reconciliation

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President Dissanayake

President Anura Kumara Dissanayake has been investing his political capital in going to the public to explain some of the most politically sensitive and controversial issues. At a time when easier political choices are available, the president is choosing the harder path of confronting ethnic suspicion and communal fears. There are three issues in particular on which the president’s words have generated strong reactions. These are first with regard to Buddhist pilgrims going to the north of the country with nationalist motivations. Second is the controversy relating to the expansion of the Tissa Raja Maha Viharaya, a recently constructed Buddhist temple in Kankesanturai which has become a flashpoint between local Tamil residents and Sinhala nationalist groups. Third is the decision not to give the war victory a central place in the Independence Day celebrations.

Even in the opposition, when his party held only three seats in parliament, Anura Kumara Dissanayake took his role as a public educator seriously. He used to deliver lengthy, well researched and easily digestible speeches in parliament. He continues this practice as president. It can be seen that his statements are primarily meant to elevate the thinking of the people and not to win votes the easy way. The easy way to win votes whether in Sri Lanka or elsewhere in the world is to rouse nationalist and racist sentiments and ride that wave. Sri Lanka’s post independence political history shows that narrow ethnic mobilisation has often produced short term electoral gains but long term national damage.

Sections of the opposition and segments of the general public have been critical of the president for taking these positions. They have claimed that the president is taking these positions in order to obtain more Tamil votes or to appease minority communities. The same may be said in reverse of those others who take contrary positions that they seek the Sinhala votes. These political actors who thrive on nationalist mobilisation have attempted to portray the president’s statements as an abandonment of the majority community. The president’s actions need to be understood within the larger framework of national reconciliation and long term national stability.

Reconciler’s Duty

When the president referred to Buddhist pilgrims from the south going to the north, he was not speaking about pilgrims visiting long established Buddhist heritage sites such as Nagadeepa or Kandarodai. His remarks were directed at a specific and highly contentious development, the recently built Buddhist temple in Kankesanturai and those built elsewhere in the recent past in the north and east. The temple in Kankesanturai did not emerge from the religious needs of a local Buddhist community as there is none in that area. It has been constructed on land that was formerly owned and used by Tamil civilians and which came under military occupation as a high security zone. What has made the issue of the temple particularly controversial is that it was established with the support of the security forces.

The controversy has deepened because the temple authorities have sought to expand the site from approximately one acre to nearly fourteen acres on the basis that there was a historic Buddhist temple in that area up to the colonial period. However, the Tamil residents of the area fear that expansion would further displace surrounding residents and consolidate a permanent Buddhist religious presence in the present period in an area where the local population is overwhelmingly Hindu. For many Tamils in Kankesanturai, the issue is not Buddhism as a religion but the use of religion as a vehicle for territorial assertion and demographic changes in a region that bore the brunt of the war. Likewise, there are other parts of the north and east where other temples or places of worship have been established by the military personnel in their camps during their war-time occupation and questions arise regarding the future when these camps are finally closed.

There are those who have actively organised large scale pilgrimages from the south to make the Tissa temple another important religious site. These pilgrimages are framed publicly as acts of devotion but are widely perceived locally as demonstrations of dominance. Each such visit heightens tension, provokes protest by Tamil residents, and risks confrontation. For communities that experienced mass displacement, military occupation and land loss, the symbolism of a state backed religious structure on contested land with the backing of the security forces is impossible to separate from memories of war and destruction. A president committed to reconciliation cannot remain silent in the face of such provocations, however uncomfortable it may be to challenge sections of the majority community.

High-minded leadership

The controversy regarding the president’s Independence Day speech has also generated strong debate. In that speech the president did not refer to the military victory over the LTTE and also did not use the term “war heroes” to describe soldiers. For many Sinhala nationalist groups, the absence of these references was seen as an attempt to diminish the sacrifices of the armed forces. The reality is that Independence Day means very different things to different communities. In the north and east the same day is marked by protest events and mourning and as a “Black Day”, symbolising the consolidation of a state they continue to experience as excluding them and not empathizing with the full extent of their losses.

By way of contrast, the president’s objective was to ensure that Independence Day could be observed as a day that belonged to all communities in the country. It is not correct to assume that the president takes these positions in order to appease minorities or secure electoral advantage. The president is only one year into his term and does not need to take politically risky positions for short term electoral gains. Indeed, the positions he has taken involve confronting powerful nationalist political forces that can mobilise significant opposition. He risks losing majority support for his statements. This itself indicates that the motivation is not electoral calculation.

President Dissanayake has recognized that Sri Lanka’s long term political stability and economic recovery depend on building trust among communities that once peacefully coexisted and then lived through decades of war. Political leadership is ultimately tested by the willingness to say what is necessary rather than what is politically expedient. The president’s recent interventions demonstrate rare national leadership and constitute an attempt to shift public discourse away from ethnic triumphalism and toward a more inclusive conception of nationhood. Reconciliation cannot take root if national ceremonies reinforce the perception of victory for one community and defeat for another especially in an internal conflict.

BY Jehan Perera

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Recovery of LTTE weapons

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Sri Lanka Navy in action

I have read a newspaper report that the Special Task Force of Sri Lanka Police, with help of Military Intelligence, recovered three buried yet well-preserved 84mm Carl Gustaf recoilless rocket launchers used by the LTTE, in the Kudumbimalai area, Batticaloa.

These deadly weapons were used by the LTTE SEA TIGER WING to attack the Sri Lanka Navy ships and craft in 1990s. The first incident was in February 1997, off Iranativu island, in the Gulf of Mannar.

Admiral Cecil Tissera took over as Commander of the Navy on 27 January, 1997, from Admiral Mohan Samarasekara.

The fight against the LTTE was intensified from 1996 and the SLN was using her Vanguard of the Navy, Fast Attack Craft Squadron, to destroy the LTTE’s littoral fighting capabilities. Frequent confrontations against the LTTE Sea Tiger boats were reported off Mullaitivu, Point Pedro and Velvetiturai areas, where SLN units became victorious in most of these sea battles, except in a few incidents where the SLN lost Fast Attack Craft.

Carl Gustaf recoilless rocket launchers

The intelligence reports confirmed that the LTTE Sea Tigers was using new recoilless rocket launchers against aluminium-hull FACs, and they were deadly at close quarter sea battles, but the exact type of this weapon was not disclosed.

The following incident, which occurred in February 1997, helped confirm the weapon was Carl Gustaf 84 mm Recoilless gun!

DATE: 09TH FEBRUARY, 1997, morning 0600 hrs.

LOCATION: OFF IRANATHIVE.

FACs: P 460 ISRAEL BUILT, COMMANDED BY CDR MANOJ JAYESOORIYA

P 452 CDL BUILT, COMMANDED BY LCDR PM WICKRAMASINGHE (ON TEMPORARY COMMAND. PROPER OIC LCDR N HEENATIGALA)

OPERATED FROM KKS.

CONFRONTED WITH LTTE ATTACK CRAFT POWERED WITH FOUR 250 HP OUT BOARD MOTORS.

TARGET WAS DESTROYED AND ONE LTTE MEMBER WAS CAPTURED.

LEADING MARINE ENGINEERING MECHANIC OF THE FAC CAME UP TO THE BRIDGE CARRYING A PROJECTILE WHICH WAS FIRED BY THE LTTE BOAT, DURING CONFRONTATION, WHICH PENETRATED THROUGH THE FAC’s HULL, AND ENTERED THE OICs CABIN (BETWEEN THE TWO BUNKS) AND HIT THE AUXILIARY ENGINE ROOM DOOR AND HAD FALLEN DOWN WITHOUT EXPLODING. THE ENGINE ROOM DOOR WAS HEAVILY DAMAGED LOOSING THE WATER TIGHT INTEGRITY OF THE FAC.

THE PROJECTILE WAS LATER HANDED OVER TO THE NAVAL WEAPONS EXPERTS WHEN THE FACs RETURNED TO KKS. INVESTIGATIONS REVEALED THE WEAPON USED BY THE ENEMY WAS 84 mm CARL GUSTAF SHOULDER-FIRED RECOILLESS GUN AND THIS PROJECTILE WAS AN ILLUMINATER BOMB OF ONE MILLION CANDLE POWER. BUT THE ATTACKERS HAS FAILED TO REMOVE THE SAFETY PIN, THEREFORE THE BOMB WAS NOT ACTIVATED.

Sea Tigers

Carl Gustaf 84 mm recoilless gun was named after Carl Gustaf Stads Gevärsfaktori, which, initially, produced it. Sweden later developed the 84mm shoulder-fired recoilless gun by the Royal Swedish Army Materiel Administration during the second half of 1940s as a crew served man- portable infantry support gun for close range multi-role anti-armour, anti-personnel, battle field illumination, smoke screening and marking fire.

It is confirmed in Wikipedia that Carl Gustaf Recoilless shoulder-fired guns were used by the only non-state actor in the world – the LTTE – during the final Eelam War.

It is extremely important to check the batch numbers of the recently recovered three launchers to find out where they were produced and other details like how they ended up in Batticaloa, Sri Lanka?

By Admiral Ravindra C. Wijegunaratne
WV, RWP and Bar, RSP, VSV, USP, NI (M) (Pakistan), ndc, psn, Bsc (Hons) (War Studies) (Karachi) MPhil (Madras)
Former Navy Commander and Former Chief of Defence Staff
Former Chairman, Trincomalee Petroleum Terminals Ltd
Former Managing Director Ceylon Petroleum Corporation
Former High Commissioner to Pakistan

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Yellow Beatz … a style similar to K-pop!

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Yes, get ready to vibe with Yellow Beatz, Sri Lanka’s awesome girl group, keen to take Sri Lankan music to the world with a style similar to K-pop!

With high-energy beats and infectious hooks, these talented ladies are here to shake up the music scene.

Think bold moves, catchy hooks, and, of course, spicy versions of old Sinhala hits, and Yellow Beatz is the package you won’t want to miss!

According to a spokesman for the group, Yellow Beatz became a reality during the Covid period … when everyone was stuck at home, in lockdown.

“First we interviewed girls, online, and selected a team that blended well, as four voices, and then started rehearsals. One of the cover songs we recorded, during those early rehearsals, unexpectedly went viral on Facebook. From that moment onward, we continued doing cover songs, and we received a huge response. Through that, we were able to bring back some beautiful Sri Lankan musical creations that were being forgotten, and introduce them to the new generation.”

The team members, I am told, have strong musical skills and with proper training their goal is to become a vocal group recognised around the world.

Believe me, their goal, they say, is not only to take Sri Lanka’s name forward, in the music scene, but to bring home a Grammy Award, as well.

“We truly believe we can achieve this with the love and support of everyone in Sri Lanka.”

The year 2026 is very special for Yellow Beatz as they have received an exceptional opportunity to represent Sri Lanka at the World Championships of Performing Arts in the USA.

Under the guidance of Chris Raththara, the Director for Sri Lanka, and with the blessings of all Sri Lankans, the girls have a great hope that they can win this milestone.

“We believe this will be a moment of great value for us as Yellow Beatz, and also for all Sri Lankans, and it will be an important inspiration for the future of our country.”

Along with all the preparation for the event in the USA, they went on to say they also need to manage their performances, original song recordings, and everything related.

The year 2026 is very special for Yellow Beatz

“We have strong confidence in ourselves and in our sincere intentions, because we are a team that studies music deeply, researches within the field, and works to take the uniqueness of Sri Lankan identity to the world.”

At present, they gather at the Voices Lab Academy, twice a week, for new creations and concert rehearsals.

This project was created by Buddhika Dayarathne who is currently working as a Pop Vocal lecturer at SLTC Campus. Voice Lab Academy is also his own private music academy and Yellow Beatz was formed through that platform.

Buddhika is keen to take Sri Lankan music to the world with a style similar to K-Pop and Yellow Beatz began as a result of that vision. With that same aim, we all work together as one team.

“Although it was a little challenging for the four of us girls to work together at first, we have united for our goal and continue to work very flexibly and with dedication. Our parents and families also give their continuous blessings and support for this project,” Rameesha, Dinushi, Newansa and Risuri said.

Last year, Yellow Beatz released their first original song, ‘Ihirila’ , and with everything happening this year, they are also preparing for their first album.

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