Opinion
Making Immunoglobulin is no picnic

by Geewananda Gunawardana,
Ph. D.
Medicinal drugs can be divided into three major categories depending on their route of administration to patients: oral, parenteral, and topical forms. The parenteral (par = beyond, enteral = intestines) means administration not involving the intestinal or oral route. The parenteral drugs can be further classified in to four types depending on the site of administration: intravenous, intramuscular, subcutaneous, and intradermal drugs. The aim of this write up is to highlight the safety precautions involved in the manufacture of intravenous drugs as their quality, or lack of it, can be a matter of life or death for the patient.
Human skin and the lining of the alimentary canal, the epithelium, function as protective barriers preventing many environmental or food borne pathogens from entering vital organs and tissues. For example, snake bites can be lethal, but getting venom on intact skin or ingestion by a healthy person does not pose the same risk. Venoms, which are proteinaceous in nature, are digested just like any other protein and rendered harmless. On the other hand, despite its nutritious value, injection of milk intravenously is deadly. There are mechanisms to neutralize and eliminate most food borne pathogens in healthy individuals to a certain extent. However, patients are a different class as their protective mechanisms can be weakened; therefore, any form of medication is expected to meet high standards of safety and quality, but intravenous drugs require much higher standards.
Intravenous drugs (IV drugs) are directly injected into the blood stream. As a result, they bypass almost all protective mechanisms that the body has in place; and substances that are ubiquitous in our environment and are otherwise harmless, must be painstakingly eliminated fully and completely from IV drugs. Therefore, extraordinary measures must be taken to prevent contamination with such harmful substances and pathogens during manufacture, storage, and administration of IV drugs. These challenges become even harder when the drugs are derived from biological sources, as is the case with immunoglobulin that has drawn much attention lately. That is in addition to ensuring the efficacy of the drug, which is another challenge that is not addressed here.
What are the substances that must be painstakingly removed? Microorganisms including bacteria, fungi, amoeba, and their spores are the first concern. They can be eliminated by applying heat, but in the case of biologics such as immunoglobulin, heat, or terminal sterilization as it is known, cannot be applied as heat denatures the drug. Avoiding contamination of not just the drug, but any excipients and solvents etc. used, is also critical as even if the living microorganisms are destroyed, the chemicals they produce, known as endotoxins and pyrogens, survive posing serious risks. Therefore, contamination with microorganisms must be avoided throughout the supply chain, which includes water used anywhere during the process. Yes, water sounds innocuous enough, but drinking water is not good enough for IV injections. The purification of water used in IV drug manufacture is yet another involved process.
The next concern is the presence of viruses, especially when drugs come from biological sources. There are many viruses that can be transmitted this way, but the most concerned ones are Hepatitis, Human Immunodeficiency Virus (HIV), and Human T-Cell Lymphotrophic Virus. They are removed through complex filtration methods. Another concern is a type of protein known as prions, the causative agent of mad cow disease (BSE/TSE). This becomes an issue if dairy products such as lactose are used as an excipient.
It is also necessary to ensure that the materials used for the manufacture of containers and closures used to store and package the drug are compatible with it. Many plastics and metals tend to shed some of their constituents to the contents even if they do not come into direct contact. They are known as extractables and leachable, and there must be procedures in place to avoid such contamination.
To keep IV drugs safe and efficacious, the regulatory agencies have produced stringent guidelines, which the pharmaceutical manufacturers follow diligently. There are three aspects to these practices. Primarily, there must be appropriate facilities that are approved by the regulatory agency and inspected regularly for compliance. For example, the air and water in such facilities must meet specifications given in guidance. Second, the personnel must be appropriately trained, and tested routinely for their proficiency in following Good Manufacturing Practices (GMP). Third, there must be procedures in place to ensure that GMP are followed and traceable from cradle to grave of the drug.
Therefore, IV drug manufacture is not a simple undertaking; even in the developed world there are only a limited, specialized organizations that can manufacture safe and efficacious IV drugs. For example, the shortage of several IV drugs in the USA last year was caused when one manufacturing facility was taken offline. Making sure that all safety measures are taken, and the drug stays safe all the way to the patient’s bedside is a gargantuan task that everyone involved takes very seriously. This writer has worked for a major IV drug manufacturer in the USA, and the supreme question in the minds of all involved was “Would you give this drug to your loved ones, or take it yourself if the need arises?” If there was any doubt, that drug would never leave the facility. Yes, there were serious repercussions for failure to do so, but more than anything else, it was a moral and ethical obligation one has to fellow humans who are in vulnerable situations that drove that conscience. It is unthinkable that any creature would neglect such sacred values with total disregard for life that they are elected or selected to safeguard. Sadly, not only such actions are criminal, but they also cast serious doubts about our calling them humans.
Opinion
Prof. Harshana Sasanka Rambukwella: A Charismatic Pedagogue

Yesterday, a sumptuous rainbow manifested over Pera. I could not but think of you, my friend!
Harshana was my batchmate at Pera in 1997.
Since he was the only boy among a bevy of girls, taking the first year English course offered by the English Department, Professor Erskine called him the “thorn among roses” at the very first lecture we had with him. But Harshana Sasanka Rambukwella was never a thorn in anyone’s side, so the name did not stick.
He was a lovely human who was happy to spread goodwill among all he associated with. What I remember most distinctly about him is that he was level-headed even as a raw fresher and could argue a point with strength without showing an ounce of unnecessary aggression. Though he had a temper it was reserved for what called for anger.
My most distinct memory of him is when he and I went to the E.F.C. Ludowyk memorial lecture, when Dr. Jayantha Dhanapala spoke on Neruda, as a poet and diplomat. We were awe -struck and though shy as freshers enjoyed the academic atmosphere and the sophistication Dr. Dhanapala exuded. I am glad we did not know of Neruda’s darker side then. That would have spoilt the experience.
I also remember that we chortled when Professor Walter Perera told us not to partake of the refreshments, sotto voce because he had not thought that many people would show up. Then later, good old “Wally,” told us to go on and tuck in because there was enough to go around, with very visible relief. The two of us laughed and chuckled all the way home.
Those were good times.
I was reminded of his temper when I met him as my Professor in my Sociology of Education class, which he taught with Professor Harini Amarasuriya. It was one of the most enjoyable sessions that I was fortunate enough to attend. He would speak on Pierre Bourdieu with such magnanimous expertise helping even the most reluctant of students understand the depth of the French sociologist and philosopher’s views on education and other matters, relating these theories as they should be adopted in the teaching of English in Sri Lanka. When students in his zoom meetings were quiet, he would say with severity, ” the level of engagement is very low.”
The Charismatic Pedagogue was the title on one of his kuppi talks contributions. He was indeed a charismatic Pedagogue.
When he brought up the notion of the Brown Sahib and Thomas Macaulay, I could not help but feel nostalgic, reminded of the time we had spent as raw freshers at Pera. There was Ramila, who remained his best friend until he passed away and of course Prashani and many others. There was nothing very raw about Harshana. He was always a gentleman whether as a young man or as the gentleman I met last on 6th August 2022, when I first visited the PGIE. He would always check my availability when he called me later on and I would say “What men! Don’t stand on ceremony just call anytime!”
It was pure irony that he was one of the judges at a competition and when my entry which went without my name won, his happiness on my success was very evident when he called to congratulate me.
As a scholar, Professor Rambukwella has made many notable contributions both as the director of PGIE and also through his quite prolific writing and research which include research papers such as , Anagarika Dharmapala: the nation and its place in the world, Patriotic Science–The Corona Virus Pandemic, Nationalism, and Indigeneity, and the countless papers he co-authored with the best in the field, and his explorations on Sri Lankan English and last but not least his magnum opus: ‘The Politics and Poetics of Authenticity: A Cultural Genealogy of Sinhala Nationalism.’ This work translated by his good friend Professor Wasantha A. Liyanage, “Amare,” will influence the Sri Lankan reader for time to come. It was a timely and necessary work which will in future help countless students, scholars and readers make sense of the dialogue surrounding the notion of Sri Lankan Nationalism as manifest in politics and literature and Sri Lankan culture. He was not simply an academic he was a man of taste who lived and loved and partook of culture.
Harshana’s life, though brief made its mark on the world because he was not simply an idealist, he was an activist and a trade unionist. He led by example and was a mentor to countless people, students, writer and scholars and a miscellany of others who defy labelling. This must be a trait that he inherited from his father, who was a mild gentleman when we met him during his stint at the English Teaching Unit, but had a reputation as one of the best teachers and school masters Dharmaraja College, Kandy could boast of.
Harshana was a great scholar, a teacher par excellence and a warm kind hearted human being. He will be missed, not only by Prashani, and the two lovely girls about whom I have heard so much, but by everyone who knew him however briefly.
Rest easy my friend! You will be loved. Your life though brief is a cause for celebration not for lament!
By Ashanthi Ekanayake
Opinion
Ragging and loss of life

Recently another life of an undergraduate was lost due to barbaric ragging at the Sabaragamuwa University. This is not the first time this happened at this University and sometime back a girl committed suicide due to inhumane ragging. It is pertinent to examine some of the factors as to why this sort of inhumane ragging goes on unabated in the universities. The most important factor as to why ragging cannot be stopped falls on the university administration. Vice Chancellors are mortally scared of these violent student groups backed by their unions to take punitive action against the perpetrators of this violence. This may be because they want to paint a picture of a peaceful atmosphere in the universities to their political masters who appointed them in the first place. These vice Chancellors are also aware of instances where strong action taken against ragging by Vice Chancellors in the past resulted in their removal such as Prof. Epitawatte at Sri Jayewardenepura and Prof, Sujeewa Amarasena at the Ruhuna University. They desist from taking action with the students because of the fear that the students will organiSe protests and even resort to physical violence against them. Academic staff members also turn a blind eye even when they see instances where ragging is openly carried out by the seniors. This may be because they themselves were raggers in the past and see nothing harmful in such sordid instances of ragging. Unlike in the past, ragging today is inhuman, violating privacy and forcing hapless undergraduates into the worst forms of human torture.
Ragging is most prevalent in halls of residence where the wardens and sub wardens simply turn the other way and never try to stop this menace. Wardens are collecting points for their next promotion and do not see that it is their duty to look after the welfare of the students.
Police, too, are to be blamed for not taking action against raggers under the Anti-ragging Act even after the university produces these culprits at the police station. I can well remember the case of a ragging incident at the Peradeniya University, where the accused were handed over to the police and they wanted to record it as a case of two student groups involved in a fight. Some time ago, the Police Department stated that all forms of ragging should be reported to the CID but nothing happened under this arrangement. Similarly, recently the Attorney General gave an undertaking to the supreme court that the vice chancellors have been instructed to prevent ragging in the universities but this is just restricted to actions on paper and nothing substantial has come out. Similarly, the Attorney General’s department takes years to prosecute raggers who have been caught, produced before judges and released on bail. There is a case of some agriculture faculty students who were caught red handed in a safe house outside the University premises at Peradeniya several years ago. The Attorney General has still not filed action against these students.
This year 1250 students have been selected to the Faculty of Arts at the Peradeniya University, where there are only150 males including 30-Buddhist monks. This shows that males shy away from attending a state university and think that it is better for them to go to a private university where there is no ragging. In fact, private universities have more males than females and the underlying reason is the lack of ragging in these private universities.
The political parties who back the student unions cry hoarse for preserving free education but they do not have the slightest idea that these ragging incidents are a big threat to free education. It is up to the Government to set up effective mechanisms to curb ragging including strict instructions to the police and the legal system to deal with these cases under the anti-ragging act.
by Professor O. A. Ileperuma,
Emeritus Professor, University of Peradeniya
Opinion
Remembering Dr. Samuel Mathew: A Heart that Healed Countless Lives

It is with a deeply heavy heart that I express my sincere condolences on the passing of Dr. Samuel Mathew Kalarickal on the 20th of April 2024. Born in 1948, Dr. Samuel was not only a pioneer of interventional cardiology in India but a giant in South Asian healthcare whose influence extended far beyond national borders.
A Beacon of Excellence and Compassion
Known as the “Father of Angioplasty” in India, Dr. Samuel introduced life-saving coronary interventions when they were still rare. His leadership at Apollo Hospitals and Kokilaben Dhirubhai Ambani Hospital brought cardiac care to global standards. But beyond the accolades, it was his humility, compassion, and unwavering dedication to patients that truly set him apart.
A Lasting Impact on Sri Lanka
Dr. Samuel played a pivotal role in shaping modern cardiac care in Sri Lanka. In the 1990s and early 2000s, many Sri Lankan patients sought his expertise in India, trusting him with their lives. He treated them with care and dignity, leaving lasting impressions on families across the island.
He also trained and mentored numerous Sri Lankan cardiologists, generously sharing knowledge of advanced procedures and technologies. His efforts helped uplift cardiac care back home and empowered many of us to bring those skills to our own communities.
A Mentor Who Lit the Path
To me, Dr. Samuel was more than a mentor—he was a fatherly figure. I fondly recall our time at the 2011 Coimbatore meeting, where he urged me to form the Sri Lanka STEMI Forum. His guidance helped us create national strategies and treatment models for heart attack care—an initiative that continues to save lives today.
A Legacy That Lives On
Dr. Samuel leaves behind more than medical breakthroughs. He leaves behind a legacy of service, inspiration, and heart. His memory will live on in every life he touched, every doctor he guided, and every patient he healed.
You will be remembered always, Sir—not just for what you did, but for who you were.
May your soul find eternal peace.
– Dr Gotabhaya Ranasinghe
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