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NMRA boss says prices of all medicines regulated under the law ‘No need for a regulator if prices can be increased arbitrarily’

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bY SURESH PERERA

Amidst flak from the pharmaceuticals industry over the move by the regulatory watchdog to call for the cancellation of registration and import licenses of 10 drugs imported by five companies for “arbitrarily and unilaterally increasing their retail prices”, Prof. Asitha de Silva, Chairman of the National Medicines Regulatory Authority (NMRA) says there is no need for a regulator if anybody can bring medicines, sell at whatever prices they want and increase prices whenever they want.

“In terms of the regulatory provisions, we not only look at the safety, quality and efficacy of drugs, but also the key aspect of affordability”, he outlined in the backdrop of the pharmaceutical industry’s representative body slamming the regulator for displaying, what it termed, “a dangerous, discriminatory trend by selectively issuing cancellation notices”.

 

What the NMRA has done is illegal because the 10 imported products concerned do not fall within the ambit of “price-controlled essential drugs”, protested Ms. Kasturi Wilson, President of the Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI).

 

How can the NMRA claim the importers had violated price regulations by “arbitrarily and unilaterally increasing their retail prices” when the regulator has authority only over 74 essential drugs within the price control mechanism?, she queried.

 

Under a gazetted order, the prices of all medicines are regulated and cannot be increased willy-nilly, Prof. de Silva clarified. “To claim there’s no price regulation on all medicines is patently false”.

 

Can anybody assert that one medicine is more useful than the other, depending on the illness of a patient under treatment?, he asked.

 

In 2015, the Supreme Court made an observation that affordability was key to patient centric medicines and NMRA’s function and duty should be to make medicines affordable to the common man, he recalled.

 

“Under Section 3 of the NMRA Act, we have wide powers to regulate prices of all medicines with the objective of bringing them within the reach of the public”, de Silva continued.

 

What the importers of the drugs did was to marginally adjust prices, which was inevitable due to the challenging situation of the Rupee vs Dollar depreciation, Ms. Wilson explained. “They didn’t even take into account the manufacturing cost fluctuations”.

 

“If there was an adverse impact due to currency fluctuations, they should have discussed the issue with us without arbitrarily increasing prices of drugs”, the NMRA boss reasoned.

 

On July 17, 2020, the NMRA issued notice calling for the cancellation of registrations and import licenses in relation to 10 specific drugs imported by Hemas Pharmaceuticals (Pvt) Ltd., (trade name of medicines: Zeos 10mg, Herbesser 100mg, Xon Ce), A. Baur & Co (Pvt) Ltd., (Rivotril 0.5mg & 2mg, Calcivita), Euro Asian Pharma (Pvt) Ltd., (Levitoz 5mg, Dozil 5mg &10mg), Pettah Pharmacy (Pvt) Ltd., (Daktacort cream) and Robert Hall & Co. (Pvt) Ltd., (Betadine cream), for “violating conditions of registration”.

 

In issuing notice, the NMRA said the arbitrary increase in the price of drugs in violation of conditions of registration will cause much hardship to patients, especially in the background of the ongoing Covid-19 pandemic. Therefore, punitive action has been taken against offending companies under powers vested with the Authority to ensure affordability of medicines available to the public.

 

The NMRA has not canceled the registration and import licenses of the five pharmaceutical companies so far. With notice issued, they can make their submissions for consideration, the Chairman elaborated.

 

There is no stated condition either in the primary registration certificate, the renewal registration certificate or in any associated existing document or communication that a price increase cannot be made, the SLCPI asserted.

 

The SLCPI is merely trying to fall back on one line in the regulatory framework and use it to its benefit. Taken as a whole, the NMRA is legally empowered to regulate prices of all medicines, the senior Professor of Pharmacology further said.

 

At a time there is a global shortage of Vitamin C, one of the importers has been taken to task for adjusting the price of the product Xon Ce, Ms. Wilson noted. “The NMRA should be conscious of the plunge of the Rupee against the USD, and the serious situation of shortages globally caused by the Covid-19 pandemic”.

 

“Our top priority is to ensure a continuous supply of drugs to patients”, she stressed, while adding that if there is a disruption, the products will be brought down through unauthorized channels and sold for double or treble the original prices.

 

Under the circumstances, the industry was compelled to do some marginal price adjustments to prevent any shortages of these drugs in Sri Lanka, she elaborated.

 

What is the use of the NMRA Act passed by Parliament if importers can arbitrarily decide on pricing?, de Silva asked. “Only a few countries has a unique piece of legislation on these lines, which deals not only with safety, quality and efficacy but also on affordability of drugs”.

 

“We investigated consumer complaints on arbitrary price increases. For example, it was found that the price of a certain medicine sold at Rs. 700 in January this year was pushed up to Rs. 960 by July – within just six months”, he said.

 

When the unauthorized price revisions were taken up with the importers, a letter was received saying, more or less, that “it’s none of our business”, the NMRA chief added.



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Construction of Accident and Emergency unit at Mannar District General Hospital begins under President’s patronage

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Construction work on the Accident and Emergency Unit at the Mannar District General Hospital commenced this morning (16) under the patronage of President Anura Kumara Dissanayake.

The Accident and Emergency Unit, which is being constructed at a cost of Rs. 600 million with a grant from the Government of India, will be equipped with all modern facilities and will further expand healthcare services for the people of Mannar. Construction is scheduled to be completed in the first quarter of 2028.

Upon completion of the project, the people of Mannar will be able to receive emergency trauma care and other specialised healthcare services without having to travel to Colombo or other major cities. At the same time, the Government has taken steps to provide the Mannar District General Hospital with the medical equipment and staff required to support these services.

President Anura Kumara Dissanayake, who attended the commencement of construction work on the Accident and Emergency Unit, also engaged in a cordial conversation with members of the hospital staff.

Addressing the ceremony held thereafter, Minister of Health and Mass Media Dr. Nalinda Jayatissa said that as the Mannar area, which is expected to make an important contribution to the national economy, develops, this project will help ensure quality healthcare services for its people. The Minister further emphasised that, in creating a “A Thriving Nation – A Beautiful Life”, the Government is committed to ensuring healthy and disease-free lives for all 21.7 million citizens of the country.

Further remarks by Minister of Health and Mass Media Dr. Nalinda Jayatissa

“The Mannar District is an area that is expected to make an important contribution to our national economy. A large number of local and foreign tourists will visit this area both now and in the future.

With the development of transport facilities, Mannar will experience further economic growth. In such a context, upgrading the services of the Mannar hospital will be important in ensuring quality healthcare services for the people of this area as well as those who visit the region.

Accordingly, construction of this Accident and Emergency Unit will be completed and the facility will be made available to the public in the first quarter of 2028. In addition, staff quarters for doctors at the Mannar District General Hospital are being constructed in a four-storey building at a cost of Rs. 243 million. These construction activities are also expected to be completed within one and a half years. Construction of the new Paediatric Unit, being built at a cost of Rs. 230 million, is also expected to commence within this year.

Similarly, the CT scanner that you have been continuously requesting will be provided to you by around February next year. It is worth approximately Rs. 250 million. While these building facilities are being developed, we will also provide the staff required by the hospital. You have also received intern medical officers for the first time in the history of this hospital. Several more intern medical officers will be assigned to you this October. At the same time, steps are currently being taken to address the shortage of specialist medical officers.

On 31 October, we will recruit 2,600 new nurses, and a portion of them will be assigned to this hospital. Personnel required for the allied health professions are also currently undergoing training. Once their training is completed, the services of several of them will be made available to this hospital. In addition, we will recruit 1,100 Public Health Midwives, a portion of whom will also be assigned to this area.

This Government is taking numerous measures to provide people with healthy lives. Through these initiatives, we hope to improve the health and quality of life of the people in this area.

More than Rs. 600 billion has been allocated to the Ministry of Health over the past two years, and the President continuously monitors all its projects. Going beyond that, I am deeply grateful to the President for joining us  today.

We have received the support of the Government of India for this project. I extend my special appreciation to the Government of India, including the Prime Minister, and its people, as well as to the High Commissioner of India and his staff, who have been committed to coordinating these activities and ensuring the success of this project.

Among district hospitals, the Mannar hospital is one with very limited facilities. Despite these shortcomings, I appreciate the dedication of all members of the staff, including the doctors, who remain committed to providing the best possible service to the people. I also consider the President’s visit to be a recognition of your service.

Two years ago, on 21 September 2024, the people of this country gave a clear mandate to create a “A Thriving Nation – A Beautiful Life”. That mandate was further strengthened in November 2024. Under the mandate to create a “A Thriving Nation – A Beautiful Life”, we have been entrusted with the responsibility of ensuring healthy and disease-free lives for all citizens of this country.

Your area of residence, profession, wealth or ethnicity is of no relevance to us in this regard. The Government’s objective is to create a beautiful life through healthy and disease-free living for all 21.7 million citizens of Sri Lanka.”

High Commissioner of India Santosh Jha:

“The agreements for the emergency unit in Mannar and the medical ward complex in Mullaitivu were signed under President Dissanayake’s leadership. I am happy to see these commitments transitioning smoothly into swift implementation.

His Excellency the Prime Minister of India, Shri Narendra Modi, has said that the development assistance extended by India to Sri Lanka comes with a deep sense of responsibility, a duty that one naturally feels for one’s family member.

We remain firmly committed to working closely with the Government of Sri Lanka and the people of Sri Lanka for the well-being and prosperity of all communities across the island. As neighboring countries and close partners, we will continue to walk together this shared path toward lasting progress and development of our peoples.”

Secretary to the Ministry of Health and Mass Media Dr. Anil Jasinghe

“For several decades, injuries and accidents have been the leading cause of hospital admissions in Sri Lanka. As Mannar is geographically somewhat isolated, it is extremely important for the district to have access to quality, free healthcare services without delay.

The assignment of intern medical officers to this hospital commenced this year. Arrangements are also currently underway to purchase a CT scanner for the Mannar District General Hospital. The hospital is expected to receive improved radiology facilities by the end of this year or the beginning of next year.

I must say that, during my 36 years in public service, last year was the only period during which I did not face any financial difficulties in carrying out my duties. The prudent macroeconomic management of the current Government, including President Anura Kumara Dissanayake, has created the fiscal space required to develop the country’s health services.”

Mannar District Bishop Rt. Rev. Gnanapragasam Anthonipillai, Northern Province Governor Nagalingam Vethanayahan, Members of Parliament representing the Mannar District, Secretary to the Ministry of Defence, Air Vice Marshal Sampath Thuyacontha (Retd), Chiefs of the Defence Services, officials of the Ministry of Health, officials of the High Commission of India in Sri Lanka, Consul General of India in Jaffna Sai Murali S. and officials of the Indian Consulate in Jaffna, among others, attended the occasion.

[President’s Media Division]

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Special Cabinet Subcommittee and Officials’ Committee appointed to address El Niño Climate Impact meet

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The Special Cabinet Subcommittee and Officials’ Committee appointed to take necessary measures to address the impact of the El Niño climate phenomenon met for the fifth time at the Presidential Secretariat on Monday (14) afternoon , under the chairmanship of Minister of Environment Dr Dhammika Patabendi.

As the El Niño climate impact is expected to transition from the current dry conditions to wetter weather over the next two months, the committees held an extensive discussion on measures to address the anticipated change in weather conditions.

The committees decided to raise public awareness on potential disasters, including floods and landslides that could occur due to increased rainfall. Attention was also given to conducting disaster preparedness drills to familiarise the public with the appropriate measures to be taken in the event of such emergencies.

It was instructed that initial preparedness drills be conducted in the districts of Kandy, Badulla, Matale and Nuwara Eliya, which are considered vulnerable to landslides and that the necessary measures be taken without delay.

The meeting also decided to implement a public awareness programme through electronic and print media. Discussions were also held on the importance of preparing the public in advance by establishing operational centres at Divisional Secretariat level.

In addition, the committees reviewed the progress of relief measures already being implemented for people affected by the prevailing El Niño conditions, as well as the progress of the planned measures ahead.

Minister of Housing, Construction and Water Supply Dr Susil Ranasinghe, Minister of Plantation and Community Infrastructure Samantha Vidyaratne, Secretary/Convener of the Special Cabinet Subcommittee, Chairman of the Officials’ Committee and Chief of Staff to the President Prabath Chandrakeerthi, Secretary to the Ministry of Agriculture, Livestock, Land and Irrigation D. P. Wickramasinghe, Director General of the Department of Meteorology A. L. K. Wijemanne, Director General of the Disaster Management Centre, Major General Sampath Kotuwegoda (retired), Director General of the National Building Research Organisation Dr Gamini Jayatissa, General Manager of the National Water Supply and Drainage Board Engineer T. Bharatheedasan and officials from the relevant institutions were also present at the meeting.

[President’s Media Division]

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Where is Gnanasara Thera?Police pass buck to court

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Gnanasara Thera

by Norman Palihawadane

Bodu Bala Sena (BBS) General Secretary Ven. Galagoda Aththe Gnanasara Thera’s whereabouts have remained unknown since the Supreme Court, on Monday, annulled a presidential pardon granted to him in 2019.

Prison officers visited the Thera’s temple in Nawala, Rajagiriya, to take steps to return him to prison to serve the unexpired portion of his six-year sentence. However, monks at the temple had reportedly informed the officials that they were unaware of his whereabouts.

Police spokesman ASP F.U. Wootler said a separate court order was required for the police to trace the Thera, or assist in taking him into prison custody. No such order had been issued so far, he claimed.

Meanwhile, sources close to Gnanasara Thera said he was expected to attend a book launch in Colombo tomorrow (17),

The development follows the Supreme Court declaring the 2019 presidential pardon granted to Gnanasara Thera, by then President Maithripala Sirisena, null and void.

A three-member Supreme Court bench held that the pardon had been granted arbitrarily and violated public trust and principles of natural justice.

Gnanasara Thera had been serving a six-year prison sentence for contempt of court when the then President Sirisena granted him the pardon, in May, 2019. He had served only about nine months of the sentence at the time.

With the pardon annulled, the original sentence remains in force and the Thera is now required to serve the balance of his six-year term.

The Supreme Court ruling has raised questions over the procedure to be followed to return him to prison, with police and prison authorities yet to take custody of him.

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