30 September, 2020

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National Medicinal Drugs Regulatory Authority Bill Violates National Medicinal Drugs Policy

The draft National Medicinal Drugs, Devices and Cosmetic regulatory Authority bill clearly violates the principles and directives given by the National Medicinal Drugs Policy of Sri Lanka, Professionals concerned on the threat to the Health of the Nation said today.

Health Minister Sirisena

Health Minister Sirisena

Writing to the Health Minister, the Peoples’ Health Forum today accused the minister for not officially circulating the draft bill which is scheduled to be presented to the Cabinet on 8th May to any individuals or professional organizations for comments.

We publish below the letter to the Minister in full;

Dear Sir,

We would like to draw your urgent attention to several important issues in relation to the National Medicinal Drugs, Devices and Cosmetic regulatory Authority Bill, which is scheduled to be presented to the Cabinet of Ministers on 8th May.

  1. The draft bill was not officially circulated to any individuals or professional organizations for comments up to now.  Only a handful of individuals have dratted this bill, which is kept as a secret from the citizen of this country.  This bill deal with “Life and Death” of the masses of this country. As citizens of this country who are directly affected by this bill we should be given the opportunity to review it.  We as professionals had to obtain a copy of the bill presented to the Cabinet in an unofficial manner.  Our comments are based on the draft obtain through such means.
  2. The purpose of this bill is to formulate a legal framework to implement the National Medicinal Drugs Policy (NMDP) that was approved by the Cabinet of Ministers in September 2005 which was developed based on the principles laid down by late Prof. Senaka Bibile.  However, we find the draft bill clearly violates the principles and directives given by the National Medicinal Drugs Policy of Sri Lanka
  3. The main intention of establishing the National Medicinal Drugs, Devices and Cosmetic regulatory Authority is to rectify the major issues in drug regulation in the country.  It was observed that the present system is not effective and leading to corrupt practices, substandard drugs been imported to the country, frequent quality issues, frequent shortages and huge financial burden to the Ministry of Health. Hence, NMDP clearly decided to establish a Drug Regulatory Authority under the Minster of Health BUT outside the departmental structure of the Ministry of Health.   The initial draft of the Bill done in 2007-2009 period had this clearly stated with a Structure of the “New Authority”. However, we find the present bill has totally changed this structure.
  4. The present bill has suggested a “Authority” mealy to endorse the work done by the existing drug regulatory division.  According to the new bill, National Medicinal Drugs, Devices and Cosmetic regulatory Authority is only a board of management with a CEO.  But the bill does not spell out the structure of the Authority. 
  5. According the new bill, the existing DRA has changed its name to MDR division within the directorate of DDGLS.  Hence, the new bill continues to have the “Actual drug regulatory work “within the existing system without handing over to the proposed “Authority”. This is clear Violation of the National Policy.   As stated above this is an attempt to mislead the whole nation by calming “A new Authority is established under the new Bill”.
  6. If this bill is enacted in this form, the Whole Nation will suffer for generations and the free health system in the country will collapse within a decade.
  7. We earnestly request you to present this bill for public comments and to rectify those gross errors though a fruitful dialogue.  We have only shown one fundamental flaw in the Bill. There are many more to be corrected.
  8. Concerned professionals are ready to explain the gross errors in this bill if we are provided with an opportunity to meet the Minister of Health in person.

Thank you

Professionals concerned on the threat to the Health of the Nation

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Latest comments

  • 2
    0

    The so called Minister of Health, Sirisena, is CORRUPT to the CORE. His brother and family have stolen reservation land from the Parakrama Samudra in Pollonnaruwa to build an ugly hotel called SUDU ARALIYA.

    Health professionals need to call for Sirisena’s immediate RESIGNATION for deaths caused due to corruption in purchase of essential drugs and delaying the National Drugs Policy Bill, and the mess in the Health Sectors. Cancer patients died some time back.
    Nurses are on strike and the ignorant and corrupt Minister is passing the buck instead of solving the problems in the sector and DELAYING as with the National Drugs Bill.

    Time has run out and Sinhalaya Modayas need to rise up and demand ACCOUNTABILITY from the CORRUPT clown Sirisea and from Jarapassa and his Cabinet of uneducated morons who are responsible for strikes and disasters in the Transport and Education sector as well.

    • 3
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      Sirisena does not have to resign.

      Instead Sirisena Co. should be arrested and charged at once for serious corruption.

      Cheers!

      PS: Next Presidential Campaign of the opposition must promise the nation severe & swift punishment to all those who shamelessly steal from this impoverished country.

      Where most people struggle for their daily bread, health services, transport & education.

      Stolen wealth will be ceased from SLFP’s corrupt elite and returned to our overburdened treasury. Period.

      • 3
        0

        Corruption has trickled down from Mahinda Rajapaksa and his family of criminals and cronies.

        The SLFP is full of RENT SEEKERS and the media needs to do a cartoon of all the Ministers and the corruption that they are accused of in the various sectors – Sports, Health, Education, Transport, Energy etc..

        The voter must be educated on the stinking levels of corruption of the Jarapassa cabinet of corrupt and uneducated clowns..

        • 1
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          Good idea! Over to you CT!

          A cartoon of corruption of the Rajapaksa Cabinet would GO VIRAL.

          Mahinda Rajapaksa ‘s cabinet is full of Sinhala and Muslim crooks including Minister of Justice, and Tamil War lords and war criminals..

          for a creative cartoon lampooning corruption – in the Sinhala Language to educated the deluded masses..

          • 1
            0

            Dude good idea! A CORRUPTION CARTOON of Rajapaksa’s cabinet of clowns – CT editors please commission a SPITTING IMAGE style cartoon to which CT contributors may add… Would be fun and could be translated into Sinhala too…
            Minister of Youth Affairs, Women;s affairs, health, ed, energy, all the 100 cabinet of clowns…
            a great collective nedia project to raise awareness of the corruption

            • 0
              0

              Dividing, and distracting and ruling the health sector is the motto of the Ministry of Health. Doctors, nurses, paramedics, midwives unions are set up to fight with one another while the corrupt Minister sits Back and makes money from pharmaceutical companies rather than pass the national drugs policy bill..

              This is the Jarapassa mode of DIVIDE, DISTRACT and RULE Sinhala Modayas, applies to the Health Sector. Time to hole Jarapass and the cabinet of UNEDUCATED clowns ACCOUNTABLE.

              Sirisena must RESIGN or be kicked out!

              • 0
                0

                There is a massive student protest on right now at Vihara Maha Devi Park Colombo as the UN World Youth conference in support of Namal Jarapassa goes on in Hambantota…

                Tomorrow the Daily Mirror, Jarapassa rag will have more mug shots of the dictators and his off spring rather than the protest of impoverished and desperate students and youth of Sri Lanka in the Capital!

                The media is a disgrace in its obsession with showing pictures of politicians and the Rajapaksa criminals, rather than protests of the people..

    • 2
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      SM you are spot on!
      Gota the goon is opening a MILITARY HOSPITAL today. Already the de facto military hospital – Lanka Hospitals which was built by Apollo India and taken over by Gota is accused of organ and kidney trafficking!

      The so-called Minister of Health is clueless and corrupt and need to be kicked out. This Sirisena Corrupt joker is paid off by Pharmaceutical companies NOT to pass the National Drugs Bill is a CRIMINAL and must be held ACCOUNTABLE for the deaths due to the mess in the Health Sector.
      It is astonishing that the Doctors have not got together to expose all the corruption.
      The media too seems to be asleep – with Daily Mirror carrying pictures of Jrapassa giving gifts to the Saffron mob rather than exposing corruption in health, education and transport sectors. As for the UNP opposition in Parliament – well that is a joke!

    • 1
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      Journalists and media need to learn to do SERIOUS rather than sensationalist INVESTIGATIVE REPORTING and analysis of SECTORS in collaboration with professionals and experts to expose the Corruption and ROT in ALL the Ministries..

      We need a proper MACRO analysis of the HEALTH SECTOR and expose of all the corruption within..

      And for all the other sectors too.. environment, roads, sports etc. Education

      Systematic sector-wide analysis and exposure of corruption is needed..

      • 1
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        The CORRUPTION KING, Sirisena spent millions from the Health Ministry on the SLFP May Day Perahera at the Chinese Nelum Pokuna to boost himself and Jarapassa…

        He wants to be the next President of Sinhala Modayas and leader of the SLFP.. what a circus!

  • 1
    0

    Enough is enough – Mahipala Sirisena MUST RESIGN! This bill reeks of CORRUPTION and is another attempt to delay. Meanwhile patients are dying due to the corruption in the health sector.

  • 1
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    The system has been corrupt right throughout! The bill will only legalise it!!! The previous minister with the secretary and DG went on till midnight after hours to make the deals with the drug companies. One official was investigated by the then bribery commissioner for having huge sums of money in the account! It was through this official that the money was shunted to the gona’rable minister!! As expected it was swept under the carpet. While negotiating sexploitation also happened since hindrance after hours was minimal. Anyhow everyone gained by the process!
    The basic policy of the chinthanaya is: make money as long as you facilitate our major share while safeguarding us!! You may be the ‘fall guy’ if things go wrong! That’s the risk you take, but for us there is no risk!! Best example of a fall guy……. DIG Vass Gunewardena
    Ashcharyamath subha anagathayak!

    • 0
      0

      Indeed the fat TUB, Nimal Siripala de Silva the other wanna be leader of the SLFP is a criminal crook who prevented passage of the national drugs policy bill during his tenure of as so-called Minister of Health.

      Nimal Siripala and Mahipala Sirisena are both CORRUPT CROOKS and so-called leaders of the SLFP.
      Oh what a mess the 2 main political parties – UNP and SLFP – are. It is the politicians of these two parties that have destroyed democracy and kept the Sinhala Modayas terribly STUPID in order DIVIDE, DISTRACT and RULE the land of the Modayas!

  • 0
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    We are not living in the closed economy of Prof Senaka Bibile. Hence, the principles laid down by late Prof. Senaka Bibile are unsuitable for Sri Lanka, which is emerging as a hub for Medical Tourism.

    The Peoples’ Health Forum consists mostly of retired medical administrators, who consistently created drug shortages through short shipments of 20 to 30% of the substandard drugs imported by them for use in government hospitals. They are free to suggest Senake Bibile policies for generic drugs imported from well known sources with international accreditation, for use in government hospitals. Unfortunately, even at present, majority of the drugs imported for use in our hospitals are from backyard producers, who supply substandard drugs. The focus of the proposed Regulatory Authority should be to ensure that only generic drugs from highly reputed sources are imported for use in the government hospitals.

    The proposed regulatory authority must not kill thousands of people who buy modern drugs supplied in packages that ensure best results or the thriving private hospital sector that is attracting patients not only from the region, but also from many highly developed countries.

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