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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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Inescapable need to deal with the past

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The sudden reemergence of two major incidents from the past, that had become peripheral to the concerns of people today, has jolted the national polity and come to its centre stage.  These are the interview by former president Ranil Wickremesinghe with the Al Jazeera television station that elicited the Batalanda issue and now the sanctioning of three former military commanders of the Sri Lankan armed forces and an LTTE commander, who switched sides and joined the government.  The key lesson that these two incidents give is that allegations of mass crimes, whether they arise nationally or internationally, have to be dealt with at some time or the other.  If they are not, they continue to fester beneath the surface until they rise again in a most unexpected way and when they may be more difficult to deal with.

In the case of the Batalanda interrogation site, the sudden reemergence of issues that seemed buried in the past has given rise to conjecture.  The Batalanda issue, which goes back 37 years, was never totally off the radar.  But after the last of the commission reports of the JVP period had been published over two decades ago, this matter was no longer at the forefront of public consciousness.  Most of those in the younger generations who were too young to know what happened at that time, or born afterwards, would scarcely have any idea of what happened at Batalanda.  But once the issue of human rights violations surfaced on Al Jazeera television they have come to occupy centre stage. From the day the former president gave his fateful interview there are commentaries on it both in the mainstream media and on social media.

There seems to be a sustained effort to keep the issue alive.  The issues of Batalanda provide good fodder to politicians who are campaigning for election at the forthcoming Local Government elections on May 6.  It is notable that the publicity on what transpired at Batalanda provides a way in which the outcome of the forthcoming local government elections in the worst affected parts of the country may be swayed.  The problem is that the main contesting political parties are liable to be accused of participation in the JVP insurrection or its suppression or both.  This may account for the widening of the scope of the allegations to include other sites such as Matale.

POLITICAL IMPERATIVES

The emergence at this time of the human rights violations and war crimes that took place during the LTTE war have their own political reasons, though these are external. The pursuit of truth and accountability must be universal and free from political motivations. Justice cannot be applied selectively. While human rights violations and war crimes call for universal standards that are applicable to all including those being committed at this time in Gaza and Ukraine, political imperatives influence what is surfaced.  The sanctioning of the four military commanders by the UK government has been justified by the UK government minister concerned as being the fulfilment of an election pledge that he had made to his constituents.  It is notable that the countries at the forefront of justice for Sri Lanka have large Tamil Diasporas that act as vote banks. It usually takes long time to prosecute human rights violations internationally whether it be in South America or East Timor and diasporas have the staying power and resources to keep going on.

 In its response to the sanctions placed on the military commanders, the government’s position is that such unilateral decisions by foreign government are not helpful and complicate the task of national reconciliation.  It has faced criticism for its restrained response, with some expecting a more forceful rebuttal against the international community. However, the NPP government is not the first to have had to face such problems.  The sanctioning of military commanders and even of former presidents has taken place during the periods of previous governments.   One of the former commanders who has been sanctioned by the UK government at this time was also sanctioned by the US government in 2020.  This was followed by the Canadian government which sanctioned two former presidents in 2023.  Neither of the two governments in power at that time took visibly stronger stands.

In addition, resolutions on Sri Lanka have been a regular occurrence and have been passed over the Sri Lankan government’s opposition since 2012.  Apart from the very first vote that took place in 2009 when the government promised to take necessary action to deal with the human rights violations of the past, and won that vote, the government has lost every succeeding vote with the margins of defeat becoming bigger and bigger.  This process has now culminated in an evidence gathering unit being set up in Geneva to collect evidence of human rights violations in Sri Lanka that is on offer to international governments to use.  This is not a safe situation for Sri Lankan leaders to be in as they can be taken before international courts in foreign countries. It is important for Sri Lanka’s sovereignty and dignity as a country that this trend comes to an end.

COMPREHENSIVE SOLUTION

A peaceful future for Sri Lanka requires a multi-dimensional approach that addresses the root causes of conflict while fostering reconciliation, justice, and inclusive development. So far the government’s response to the international pressures is to indicate that it will strengthen the internal mechanisms already in place like the Office on Missing Persons and in addition to set up a truth and reconciliation commission.   The difficulty that the government will face is to obtain a national consensus behind this truth and reconciliation commission.  Tamil parties and victims’ groups in particular have voiced scepticism about the value of this mechanism. They have seen commissions come and commissions go. Sinhalese nationalist parties are also highly critical of the need for such commissions.  As the Nawaz Commission appointed to identify the recommendations of previous commissions observed, “Our island nation has had a surfeit of commissions. Many witnesses who testified before this commission narrated their disappointment of going before previous commissions and achieving nothing in return.”

Former minister Prof G L Peiris has written a detailed critique of the proposed truth and reconciliation law that the previous government prepared but did not present to parliament.

In his critique, Prof Peiris had drawn from the South African truth and reconciliation commission which is the best known and most thoroughly implemented one in the world.  He points out that the South African commission had a mandate to cover the entire country and not only some parts of it like the Sri Lankan law proposes.  The need for a Sri Lankan truth and reconciliation commission to cover the entire country and not only the north and east is clear in the reemergence of the Batalanda issue.  Serious human rights violations have occurred in all parts of the country, and to those from all ethnic and religious communities, and not only in the north and east.

Dealing with the past can only be successful in the context of a “system change” in which there is mutual agreement about the future.  The longer this is delayed, the more scepticism will grow among victims and the broader public about the government’s commitment to a solution. The important feature of the South African commission was that it was part of a larger political process aimed to build national consensus through a long and strenuous process of consultations.  The ultimate goal of the South African reconciliation process was a comprehensive political settlement that included power-sharing between racial groups and accountability measures that facilitated healing for all sides. If Sri Lanka is to achieve genuine reconciliation, it is necessary to learn from these experiences and take decisive steps to address past injustices in a manner that fosters lasting national unity.  A peaceful Sri Lanka is possible if the government, opposition and people commit to truth, justice and inclusivity.

 

by Jehan Perera

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Unleashing Minds: From oppression to liberation

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“Private tuition centres, private schools, and institutions offering degree programmes for a fee all play a significant role in deepening the disparities between different social classes.”

Education should be genuinely ‘free’—not just in the sense of being free from privatisation, but also in a way that empowers students by freeing them from oppressive structures. It should provide them with the knowledge and tools necessary to think critically, question the status quo, and ultimately liberate themselves from oppressive systems.

Education as an oppressive structure

Education should empower students to think critically, challenge oppression, and envision a more just and equal world. However, in its current state, education often operates as a mechanism of oppression rather than liberation. Instead of fostering independent thinking and change, the education system tends to reinforce the existing power dynamics and social hierarchies. It often upholds the status quo by teaching conformity and compliance rather than critical inquiry and transformation. This results in the reproduction of various inequalities, including economic, racial, and social disparities, further entrenching divisions within society. As a result, instead of being a force for personal and societal empowerment, education inadvertently perpetuates the very systems that contribute to injustice and inequality.

Education sustaining the class structure

Due to the widespread privatisation of education, the system continues to reinforce and sustain existing class structures. Private tuition centres, private schools, and institutions offering degree programmes for a fee all play a significant role in deepening the disparities between different social classes. These private entities often cater to the more affluent segments of society, granting them access to superior education and resources. In contrast, students from less privileged backgrounds are left with fewer opportunities and limited access to quality education, exacerbating the divide between the wealthy and the underprivileged. This growing gap in educational access not only limits social mobility but also perpetuates a cycle where the privileged continue to secure better opportunities while the less fortunate struggle to break free from the constraints of their socio-economic status.

Gender Oppression

Education subtly perpetuates gender oppression in society by reinforcing stereotypes, promoting gender insensitivity, and failing to create a gender-sensitive education system. And some of the policymakers do perpetuate this gender insensitive education by misinforming people. In a recent press conference, one of the former members of Parliament, Wimal Weerawansa, accused gender studies of spreading a ‘disease’ among students. In the year 2025, we are still hearing such absurdities discouraging gender studies. It is troubling and perplexing to hear such outdated and regressive views being voiced by public figures, particularly at a time when societies, worldwide, are increasingly embracing diversity and inclusion. These comments not only undermine the importance of gender studies as an academic field but also reinforce harmful stereotypes that marginalise individuals who do not fit into traditional gender roles. As we move forward in an era of greater social progress, such antiquated views only serve to hinder the ongoing work of fostering equality and understanding for all people, regardless of gender identity.

Students, whether in schools or universities, are often immersed in an educational discourse where gender is treated as something external, rather than an essential aspect of their everyday lives. In this framework, gender is framed as a concern primarily for “non-males,” which marginalises the broader societal impact of gender issues. This perspective fails to recognise that gender dynamics affect everyone, regardless of their gender identity, and that understanding and addressing gender inequality is crucial for all individuals in society.

A poignant example of this issue can be seen in the recent troubling case of sexual abuse involving a medical doctor. The public discussion surrounding the incident, particularly the media’s decision to disclose the victim’s confidential statement, is deeply concerning. This lack of respect for privacy and sensitivity highlights the pervasive disregard for gender issues in society.

What makes this situation even more alarming is that such media behaviour is not an isolated incident, but rather reflects a broader pattern in a society where gender sensitivity is often dismissed or ignored. In many circles, advocating for gender equality and sensitivity is stigmatised, and is even seen as a ‘disease’ or a disruptive force to the status quo. This attitude contributes to a culture where harmful gender stereotypes persist, and where important conversations about gender equity are sidelined or distorted. Ultimately, this reflects the deeper societal need for an education system that is more attuned to gender sensitivity, recognising its critical role in shaping the world students will inherit and navigate.

To break free from these gender hierarchies there should be, among other things, a gender sensitive education system, which does not limit gender studies to a semester or a mere subject.

Ragging

The inequality that persists in class and regional power structures (Colombo and non-Colombo division) creeps into universities. While ragging is popularly seen as an act of integrating freshers into the system, its roots lie in the deeply divided class and ethno-religious divisions within society.

In certain faculties, senior students may ask junior female students to wear certain fabrics typically worn at home (cheetta dresses) and braid their hair into two plaits, while male students are required to wear white, long-sleeved shirts without belts. Both men and women must wear bathroom slippers. These actions are framed as efforts to make everyone equal, free from class divisions. However, these gendered and ethicised practices stem from unequal and oppressive class structures in society and are gradually infiltrating university culture as mechanisms of oppression.The inequality that persists in gradually makes its way into academic institutions, particularly universities.

These practices are ostensibly intended to create a sense of uniformity and equality among students, removing visible markers of class distinction. However, what is overlooked is that these actions stem from deeply ingrained and unequal social structures that are inherently oppressive. Instead of fostering equality, they reinforce a system where hierarchical power dynamics in the society—rooted in class, gender, and region—are confronted with oppression and violence which is embedded in ragging, creating another system of oppression.

Uncritical Students

In Sri Lanka, and in many other countries across the region, it is common for university students to address their lecturers as ‘Sir’ and ‘Madam.’ This practice is not just a matter of politeness, but rather a reflection of deeply ingrained societal norms that date back to the feudal and colonial eras. The use of these titles reinforces a hierarchical structure within the educational system, where authority is unquestioned, and students are expected to show deference to their professors.

Historically, during colonial rule, the education system was structured around European models, which often emphasised rigid social distinctions and the authority of those in power. The titles ‘Sir’ and ‘Madam’ served to uphold this structure, positioning lecturers as figures of authority who were to be respected and rarely challenged. Even after the end of colonial rule, these practices continued to permeate the education system, becoming normalised as part of the culture.

This practice perpetuates a culture of obedience and respect for authority that discourages critical thinking and active questioning. In this context, students are conditioned to see their lecturers as figures of unquestionable authority, discouraging dialogue, dissent, or challenging the status quo. This hierarchical dynamic can limit intellectual growth and discourage students from engaging in open, critical discussions that could lead to progressive change within both academia and society at large.

Unleashing minds

The transformation of these structures lies in the hands of multiple parties, including academics, students, society, and policymakers. Policymakers must create and enforce policies that discourage the privatisation of education, ensure equal access for all students, regardless of class dynamics, gender, etc. Education should be regarded as a fundamental right, not a privilege available only to a select few. Such policies should also actively promote gender equality and inclusivity, addressing the barriers that prevent women, LGBTQ+ individuals, and other marginalised genders from accessing and succeeding in education. Practices that perpetuate gender inequality, such as sexism, discrimination, or gender-based violence, need to be addressed head-on. Institutions must prioritise gender studies and sensitivity training to cultivate an environment of respect and understanding, where all students, regardless of gender, feel safe and valued.

At the same time, the micro-ecosystems of hierarchy within institutions—such as maintaining outdated power structures and social divisions—must be thoroughly examined and challenged. Universities must foster environments where critical thinking, mutual respect, and inclusivity—across both class and gender—are prioritised. By creating spaces where all minds can flourish, free from the constraints of entrenched hierarchies, we can build a more equitable and intellectually vibrant educational system—one that truly unleashes the potential of all students, regardless of their social background.

(Anushka Kahandagamage is the General Secretary of the Colombo Institute for Human Sciences)

Kuppi is a politics and pedagogy happening on the margins of the lecture hall that parodies, subverts, and simultaneously reaffirms social hierarchies.

By Anushka Kahandagamage

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New vision for bassist Benjy

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It’s a known fact that whenever bassist Benjy Ranabahu booms into action he literally lights up the stage, and the exciting news I have for music lovers, this week, is that Benjy is coming up with a new vision.

One thought that this exciting bassist may give the music scene a layoff, after his return from the Seychelles early this year.

At that point in time, he indicated to us that he hasn’t quit the music scene, but that he would like to take a break from the showbiz setup.

“I’m taking things easy at the moment…just need to relax and then decide what my future plans would be,” he said.

However, the good news is that Benjy’s future plans would materialise sooner than one thought.

Yes, Benjy is putting together his own band, with a vision to give music lovers something different, something dynamic.

He has already got the lineup to do the needful, he says, and the guys are now working on their repertoire.

The five-piece lineup will include lead, rhythm, bass, keyboards and drums and the plus factor, said Benjy, is that they all sing.

A female vocalist has also been added to this setup, said Benjy.

“She is relatively new to the scene, but with a trained voice, and that means we have something new to offer music lovers.”

The setup met last week and had a frank discussion on how they intend taking on the music scene and everyone seems excited to get on stage and do the needful, Benjy added.

Benjy went on to say that they are now spending their time rehearsing as they are very keen to gel as a team, because their skills and personalities fit together well.

“The guys I’ve got are all extremely talented and skillful in their profession and they have been around for quite a while, performing as professionals, both here and abroad.”

Benjy himself has performed with several top bands in the past and also had his own band – Aquarius.

Aquarius had quite a few foreign contracts, as well, performing in Europe and in the Middle East, and Benjy is now ready to do it again!

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