People forced to make do with poor quality drugs while NMRA calls the shots

The shortage of pharmaceuticals and the poor quality of the available drugs are common subjects of discussion in our society today. All drugs imported to a country need to be registered and certified by a Drug Authority. We in Sri Lanka had a fairly efficient body called the CDDA (Cosmetic Devices and Drug Regulatory Authority) reporting to the Director of Health of the Ministry. Its functions have now been taken over by a body called the NMRA (National Medicines Regulatory Authority) – an independent body not answerable to the Director.

This body was established to expose the ugly side of international Big Pharma. The NMRA has today become a true ‘Drug Mafia’ of Sri Lanka that decides on the availability and pricing of drugs the way they want without any consultation with stakeholders nor listening to public opinion.

All the well-known drugs used by doctors over many generations have disappeared from the market and only unknown substandard drugs are available for the doctors to prescribe. It is a wonder that the practising doctors are keeping mum about such important issues.

One of the main reasons for the well-known companies to keep away from submitting registrations is due to the NMRA demand for what is called the Site Master File even from the world renowned manufacturers for the registration of a drug. These are highly confidential details indicating the entire process and the site of manufactory of a product which remains a closely guarded trade secret – methods specialized by a given company. Once it is published and given to an organization like NMRA, it can very easily find its way to competitors. This is one of the main reasons for the non-availability of high-quality drugs in the country.

The cost of registration of a drug has not only risen to over US$ 2000 -3000 (priced in US Dollars which must be illegal) while it had been a mere Rs. 2000 under the CDDA. Moreover, the registration process takes a minimum of 12- 18 months during which time patients must wait.

The registration procedure involves only checking the data provided for the registration and comparing with the standard data inhouse. There are about 200 pages in an application dossier which should not take anything more than a week at the most. Accordingly, it is worth finding out the average number of dossiers received per month and the number of pharmacists available.

The delay of finalising a registration dossier is purely due to delaying tactics to earn an extra buck. This practice is taking place from the peon upwards.

L.M. Peiris (Retd. Pharmacist) Via email