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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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EC: HC judgment won’t bar Premalal from contesting

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… former, present polls monitors differ

By Shamindra Ferdinando

Election Commission (EC) Chairman Mahinda Deshapriya yesterday (3) said that the recent Ratnapura High Court ruling, in respect of the 2015 January Kahawatte killing, wouldn’t bar SLPP candidate Premalal Jayasekera from contesting the parliamentary polls on August 5.

 Deshapriya said so when The Island asked for comment on the Ratnapura, High Court sentencing the SLPP candidate, along with two others, to death, over the killing of a person backing the then common candidate Maithripala Sirisena.

At the time of the incident, Jayasekera held the post of Deputy Minister in the SLFP-led UPFA government.

Deshapriya said that there had never been a similar case before though there had been cases of elected lawmakers being unseated after being found guilty by courts.

 “We’ll discuss the issue at hand after the election and decide what to do,” Deshapriya said, adding that there was no change in the status quo as a result of the Ratnapura HC ruling.

The EC consists of Mahinda Deshapriya, Prof. Ratnajeevan Hoole and Nalin Abeysekera, PC.

CMEV (Center for Monitoring Election Violence) spokesman Manjula Gajanayake told The Island that the top SLPP leadership should have considered all aspects before accommodating the former lawmaker on the Ratnapura nomination list. The SLPP could have easily avoided what Gajanayake called unnecessary complication by fielding another in place of Jayasekera, Gajanayake said. The polls monitor pointed out that the SLPP was aware that the Kahawatte case had been heard and the ruling was pending.

Responding to another query, Gajanayake said that the EC as well as political parties, especially those represented in parliament would have to address the issue.

Ratnapura District SLPP list comprises Vasudeva Nanayakkara (leader), Pavitradevi Wanniarachchi, Janaka Wakkumbura, John Seneviratne, Premalal Jayasekera, Dunesh Gankanda, Akila Ellawala, Sanee Rohana Kodituwakku,  Ranjith Bandara, Gamini Waleboda, Muditha Prishanthi, Hettiarachchige Lakshman Premaratne, Athula Kumara Rahubadda and Miyuru Bhashitha Liyanage. SLPP’s 14 candidates, include six former lawmakers. Of them, Dunesh Gankanda was elected from the Ratnapura district on the UNP ticket at the last parliamentary polls in August 2015.

 The SLPP should blame itself for the crisis, Gajanayake said.

 On Feb 26, 2019 four suspects who had been charged with killing of an individual in Kahawatta during the 2015 presidential polls campaign were acquitted and released by the High Court of Ratnapura. However, Jayasekera and two others remained as accused.

 Executive Director of PAFFREL (People’s Action for Free and Fair Election) Rohana Hettiarachchi told The Island that at the time Jayasekera received nomination he hadn’t been found guilty by High Court of Ratnapura. Therefore, there couldn’t be an issue in voters exercising their franchise for Jayasekera tomorrow, Hettiarachchi said. However, the EC would have to seek legal advice before Jayasekera received oaths as a member of parliament. 

 The police arrested Jayasekera in the Beruwela police area while he was hiding after the high profile Kahawatte killing.

 CaFFE (Campaign for Free and Fair Elections) head Ahamed Manas Makeen told The Island that the electorate should exercise their franchise for those who had clean records. Those who abused women and children or encouraged such practices, bribery and corruption and engaged or promoted violence or extremism shouldn’t be encouraged. Makeen said that the CaFFE stand was relevant to all districts not only Ratnapura where a candidate was sentenced to death.

 However Makeen’s predecessor, Rajith Keerthi Tennakoon, in a letter dated Aug 2 addressed to the EC, on behalf of the Samagi Jana Balavegaya (SJB) said that in terms of the Article 89 of the Constitution a convicted murderer is automatically deprived of the right to exercise his franchise. Therefore, Jayasekera couldn’t vote at tomorrow’s general election, Tennakoon said, pointing out that in terms of Article 91 of the Constitution, a person disqualified to vote at the general election couldn’t contest. Tennakoon urged the EC to advice the Returning Officer of Ratnapura accordingly without delay.

 Keerthi functions as the SJB representative at the EC.

 SLPP Chairman Prof. G.L. Peiris said that they were watching the situation.

 

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Police initially believed in what Sampayo told them about Negombo Prison

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Image grabbed from video footage of Sampayo speaking to the media on Sunday at Kurunegala

by Norman Palihawadane

The Negombo Police, probing the alleged links between prison officials and inmates serving time there for drug offences, said that there had been numerous complaints about drug cartels operating from the Negombo Prison but former Superintendent (SP) of the Negombo Prison, Anuruddha Sampayo, always told them that there were no such rackets.

SP Sampayo was of the opinion that some elements were spreading such stories to tarnish the good name of officers attached to the Negombo prison.

Sampayo, who was evading arrest after being issued warrants, surrendered, on Sunday

Following directions of the Attorney General, the Criminal Investigation Department (CID) on July 22 obtained arrest warrants, from the Negombo Magistrate, on Sampayo and three other officials of the Negombo Prison .

Sampayo is the first suspect in the case filed over committing irregularities in the Negombo Prison. The three other suspects in the case – Chief Jailor of the Prison Upali Sarath Bandara, Second Tier Jailer Nishantha Senaratne and Jailer Prasad Kalinga Kaluaggala – surrendered to the police earlier and they were remanded until Aug 04 by the court.

Police Media Spokesman Senior Superintendent of Police Jaliya Senaratne said Sampayo had been handed over to the Criminal Investigation Department after recording a statement.

 

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Expect post-election tax shocks if SLPP wins, warns JVP leader

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JVP leader Anura Kumara Dissanayake flanked by NPP National List candidate Tuan K. Azoor and Kalutara District candidate Dr. Nihal Abeysinghe addressing a press conference held at the party headquarters on Sunday

 

By Saman Indrajith

The government is doing exactly the very obverse of what it had promised to win the presidential election, therefore people should not take the SLPP’s promises seriously, says the JVP.

Addressing the media at the party headquarters, JVP leader Anura Kumara Dissanayake said, on Sunday: “The SLPP came to power promising one law for all, but some persons are above the law. The SLPP has on its platform some characters who have Interpol red alerts against their names. They broke the quarantine laws at many places including the funeral of Minister Arumugam Thondaman. The law was bent to save the person who demolished an ancient royal pavilion at Kurunegala. That is how they maintain the rule of law.”

Dissanayake said that 6.9 million people had voted for the SLPP candidate at the last presidential polls, believing that he would not divest national assets. “There is still no clear statement that it would do away with the Millennium Challenge Corporation compact with the US. People did not vote for the SLPP to sell off the East Container Terminal of the Colombo Port. Trade Unions had to resort to strikes to obtain a promise from the Prime Minister but the problem is far from resolved. There has been a Cabinet paper to demarcate a 10-acre area covering land belonging to the Examinations Department at Malay Street, Police land in the Slave Island

and Air Force premises in adjacent area and to get it under the purview of the Urban Development Authority. We believe that their plan is to sell the entire land off in the near future.”

Dissanayake asked people to brace for massive tax hikes after Aug 5 elections because the SLPP would increase the prices of essential items to raise funds to keep the economy going. “There will be unprecedented price hikes. There will be tax increases. There is a need for a force that could fight against those moves. Only the JVP-led NPP is equal to that task. We’ll have to fight in and outside parliament. We therefore ask the people to cast their votes for the NPP and send as many as NPP members possible to the next parliament.”

NPP National List candidate Tuan K. Azoor and Kalutara District candidate Dr. Nihal Abeysinghe also addressed the press.

 

 

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