The Sunday Leader

Why Is NMRA A Bitter Pill For Rajitha To Swallow?

  • Health Ministry under fire for delay in implementing Prof. Senaka Bibile Drug Policy

by Nirmala Kannangara

Medicines at pharmacies

Although it is now more than one year since former Health Minister Maithripala Sirisena was elected as the country’s Executive President, the highly regarded Prof. Senaka Bibile Drug Policy of the early 70s which President Sirisena promised to re-implement is yet to see the light of day. It is alleged that the Health Ministry’s delay in implementing this drug policy is due to the action of persons with vested interests.

In the run-up to the 2015 presidential election, not only the former Health Minister but the present Health Minister too assured the people that quality medicine at a lower price would be provided. It was in this backdrop that the National Medicinal Regulatory Authority (NMRA) was established in July last year. Two eminent medical professionals, Prof. Lal Jayakody, Head of the Department of Pharmacology at the Colombo University and Prof. Krishantha Weerasuriya, South Asian Drug Policy Advisor to the World Health Organisation, were appointed as NMRA’s Chairman and Chief Executive Officer respectively. NMRA is an authority set up to regulate medicinal drugs and medical devices.

“Medicinal drugs and devices have to be regulated to ensure that patients get quality medicine at an affordable price,” Convener of the Prof. Senaka Bibile Foundation, Dr. Jayantha Bandara said.

However earlier this month, Health Minister Dr. Rajitha Senaratne in a surprising turn of events asked these two officials to tender their resignations with immediate effect claiming that they were not competent enough to look into drug related matters which had led to a drug shortage.

However, following requests made to President Maithripala Sirisena by other officials and the People’s Movement for the Rights of Patients, Minister Senaratne was given instructions to re-appoint both Prof. Jayakody and Prof. Weerasuriya.

“This was a huge relief to those who wish to have medicinal drugs and devices regulated. Earlier, attempts to get the Drug Policy Bill passed in parliament in order to ensure quality medicine for the people was hampered due to the ulterior motives of multinational drug companies. When the two officials were forced to resign we had a suspicion as to whether multinational drug companies had bribed the ‘big wigs’ in the Health Ministry. If that is the case, it is sad to note how the present Health Ministry officials too have started to dance to the tunes of these drug companies without providing the people a value-oriented health service,” a drug importer who wished to remain anonymous said.

Health trade unions meanwhile accused Minister Senaratne of attempting to sabotage the NMRA work by asking the Chairman and the CEO to tender their resignations. “The Minister levelled baseless allegations against the NMRA Chairman and the CEO who are highly respected professionals in their respective fields. These two officials were a threat to the multinational drug companies as they are in the process of bringing regulations to direct all doctors to write prescriptions by generic name. Once these regulations are introduced, the multinational drug companies would not be able to sell drugs keeping a profit margin of 200% to 800%,” Dr. Bandara said.

According to Dr. Bandara, multinational drug companies sell a fifty cent paracetamol tablet at Rs. 2.50 and sometimes more. According to him, the multinational drug companies have openly stated that they do not wish to see the Senaka Bibile Drug Policy implemented but only a national drug policy since they know that there are no loopholes to import quality-failed sub-standard drugs under the Senaka Bibile drug policy.

“Prof. Bibile played the leading role in developing a rational pharmaceutical policy aimed at ensuring impoverished people have access to quality drugs at a low price. A careful selection of drugs was an essential component of the policies he advocated.

At that time, it was alleged and widely believed that pharmaceutical companies in the country made considerable profits by selling drugs under their trade name giving out biased information about the branded drugs as against those named generically.”

“Prof. Bibile investigated this issue and recommended the establishment of a national policy and a state body to regularise the trade. He became the Founder Chairman of the State Pharmaceuticals Corporation (SPC). The SPC then channelled all imports of pharmaceuticals, calling for worldwide bulk tenders which were limited to the approved drugs listed in the national formulary. The public and private health sectors obtained all their requirements from the SPC. Hence this body regulated the pharmaceutical trade and the sellers were forced to compete with each other. Since 1977 this process has been defunct and the people have been suffering immensely  paying high prices for low quality and substandard drugs,” said Dr. Bandara.

According to Dr. Bandara, the World Health Organisation (WHO) and other UN agencies supported the Prof. Bibile Drug Policy with enormous benefits to third world countries and presently over 100 countries including developed nations have adopted this policy.

“The advantage would be enormous and people would be able to purchase any kind of drug under its generic name for a fair price. If this policy is implemented, the government does not need to spend billions in foreign exchange to import a number of essential drugs with a few hundred varieties. High quality drugs with fixed prices would come into the market instead of sub-standard and quality failed drugs.”

Meanwhile, a source from the  All Ceylon Nurses Services Union alleged that politicians and high ministry officials have been bribed and that this is the reason for their reticence at seeing the implementation of the drug policy.

He further stressed the need to have the National Drug Quality Assurance Laboratory (NDQAL) carry out quality checks on the drugs that enter the country.

“Most of the essential life-saving drugs come from Tamil Nadu, India where it is a cottage industry. These drugs are sub-standard and quality-failed. If Sri Lanka had followed the Senaka Bibile Drug Policy, the quality of drugs would be checked before being shipped and once again checked before unloading. Since the Health Ministry has allowed any drug to be imported from any country without any quality assurance, sub-standard and quality-failed drugs are coming in without any restriction,” the source added.

Meanwhile Dr. Jayantha Bandara said that compared to other Asian countries in the region, Sri Lanka allocates a smaller percentage of its Gross Domestic Product (GDP) for health.

“Compared to other countries, Sri Lanka allocates less for health services and when this money is spent on importing quality-failed sub-standard drugs, even that little allocation goes down the drain. What a waste to spend foreign exchange to buy medicinal drugs that are not suitable for patients,” Dr. Bandara said.

According to Dr. Bandara it is vital to have a drug information center where people can check on the drugs available in the market and their quality.

Meanwhile sources from the People’s Movement for the Rights of Patients (PMRP) said they were surprised when Minister Senaratne requested the Chairman and the CEO of NMRA to tender their resignations without any valid reason.

“The NMRA is an independent body comprising professionals and there should be no political interference in their work. This authority was established only in July last year and it is unfair to ask the Chairman and the CEO to tender their resignations. If there were shortcomings, explanations could have been called for rather than taking hasty decisions,” these sources said.

According to sources, 15, 000 varieties of drugs come into the country when the country’s health sector can manage with just 1,000 varieties. “For instance take amoxicillin which is an antibiotic; there are 100 varieties of this drug and the drug that comes under its generic name is priced at Rs. 3 while the tablet with the same chemical components when imported by multinational companies and packaged in eye-catching boxes, cost around Rs. 100. Although doctors can prescribe these drugs under the generic name, they still prescribe the medicine by the trade name as they are given free tours abroad and other perks,” sources claimed.

Attempts to contact Health Minister Dr. Senaratne for comment failed. Although a text message was sent seeking a comment, there was no response.


1 Comment for “Why Is NMRA A Bitter Pill For Rajitha To Swallow?”

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