Open letter to the Prime Minister of Mauritius, the right Honorable Pravind Kumar JUGNAUTH.
As a citizen of Mauritius and as a health professional who has worked abroad for 25 years and has returned back permanently since 2006, I would like to make certain observations and suggestions.
In July 2008 the Report of the Commission of Inquiry on Drug Trafficking (the Lam Shang Leen Report) has in no uncertain words issued an incompetency certificate to the Pharmacy Board, to its Registrar and to the Office of the Director of Pharmaceutical Services.
The Pharmacy Board (the Board) according to section 4 (b) of the Pharmacy Act is called to “exercise control over the manufacture, importation, distribution, sale, and possession of any drug, poison, dangerous drug and psychotropic substance”.
According to Judge LAM SHANG LEEN’s report, the Board was criticized for its lack of accountability and transparency. The report was on drug trafficking, on inspection of retail pharmacies, and on granting licenses to non-professionals instead of registered pharmacists. If one takes into account that no audit has been carried on the Pharmacy Board or the actions of the Registrar, one can easily understand that the amendments of the Pharmacy Act voted under the COVID Law in May 2020 is frightening.
One must be assured that the quality of the pharmaceutical drugs produced and distributed locally is according to known international standards and good manufacturing practices. The Pharmacy Act has been amended to grant the application for a license for manufacture, not later than 15 working days, after reception of the same, under section 36(3). Will the Board have all the tools, human resources to grant the permit within that limit of 15 days, when even to obtain, in a short lapse of time a building permit for a simple 2 bedrooms house is not achieved?
I am flabbergasted by the amendment 36C (8) which stipulates that the Board may exempt any locally manufactured pharmaceutical product from registration. What does this imply? Any pharmaceutical drug produced locally can be sold on the market without any clearance? Why are we going backward? I would like to point out that pharmaceutical drugs imported have to be selected according to the British or European Pharmacopoeia. On this subject, the Pharmacy Act under the COVID Law will extend the definition of “specified standards” to include the Indian Pharmacopoeia. Then why not the Pakistani or Chinese or Israeli Pharmacopoeia? To be able to have a guaranty that there is no counterfeit, international manufacturers have a responsibility to assure quality control, will we have the same here locally?
One may suspect that the pharmacy act has been amended to suit eventual businessmen waiting in the government lobby. In the budget, it is announced that the MAURITIUS INVESTMENT CORPORATION (MIC) will invest in the production of pharmaceutical products, medical devices, and personal protective equipment through a public-private enterprise.
This will be a JACKPOT for some lucky ones.
MY PROPOSITION
An urgent and complete revision of the legal framework to provide for the creation of an Act which will cater for:
The creation of a National Medicine Regulatory Agency (NMRA) to look into the manufacture, import, storage and distribution of drugs. The NMRA will be headed by a Director recruited by the Public Services Commission (PSC ). The Board of the NMRA will consist of Medical Practitioners, Pharmacists, Representatives from Customs, the Tax Payer’s Department of the Mauritius Revenue Authority (MRA), the State Law Office and the Consumers Association.
The Agency will have to be audited at least twice a year and audit reports made public.
This Act will provide also for a corps of Inspectors.
One wants to produce locally LIFE SAVING drugs, but if not addressed properly with all due precautions, it will KILL.
TRUST IS THE KEY ELEMENT.
