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

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 8^th 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