The National Medicine Regulatory Authority Bill – said to be based on Prof. Senaka Bibile’s Essential Medicines Concept

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National Drug Policy Bill : Generic Name vs Brand Name 

The National Medicine Regulatory Authority Bill – said to be based on Prof. Senaka Bibile’s Essential Medicines Concept - was passed with amendments in parliament with a majority of 67 votes. Apart from other objectives , the main focus has been on giving prominence to drugs in their generic name rather than their brand name.

By generic names, the medicinal drugs are to be regarded in their chemical compound rather than their brands. These have exactly the same dosage, intended use, effects, side effects, route of administration, risks, safety and strength and is in every way similar to the branded drug and can only be more genuine. Nevertheless since many are familiar with brand names, they give priority to this and purchase the drug that they are more accustomed to. Therefore, doctors when prescribing medication should specifically mention the generic name since such drugs are more affordable and assure high quality.

The National Drug Policy Bill that has been passed, appears to call for all medicinal drugs to be available in their generic name although certain key elements such as the principles of the bill as well as the Act has not been officially presented to the public. This has left some in a state of confusion.

Naturally, recommending drugs in their chemical components will be a direct threat to the large numbers of drug brands that are available in the market today. If the Government really acts as they promise, it would be interesting to see how they will react to this new set up. Moreover the Bill is said to provide for the establishment of a regulatory authority to be known as the National Medicines Regulatory Authority. The Authority will be responsible for the regulation and control of Registration, Licensing, Manufacture, Importation, and all other aspects pertaining to medicines, medical devices and borderline products.

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What do you feel about drugs being made available in their generic name rather than their brand name?

Nurani

As far as I know, 50% of all prescriptions in Sri Lanka are filled with brand names, the cost of which cannot be borne by an average citizen. It is good if doctors are asked to prescribe only generic named drugs when prescribing a drug to a patient. However there should be a proper mechanism to ensure that unethical pharmacists/sales persons do not make use of this to recommend extensive brands for their own profit. I trust that the National Medicine Regulatory Authority established under the recently passed NMRA Act will be able to play a vital role in addressing this issue in an effective and realistic manner. However at the same time, we should bear in mind that the decision to choose a brand name or a generic name should always involve a patient and his/her doctor as cost is only  one factor when considering the “right medication for a patient’s medical condition. - Nurani

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According to the new National Drug Policy, a regulating Authority consisting of top professionals in the health field should be established to regulate and monitor the activities. One main task will be to  monitor the import procedure for drugs. The policy specifies that tenders should be invited to import drugs under the generic names and not brand names to ensure quality standard drugs in the market at affordable prices. Furthermore the activities of drug companies should also be strictly monitored. If the Regulating Authority performs its duties properly, the availability of generic drugs in the market should ultimately benefit the drug consumers. - Mangala

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It would benefit the public a lot because most of  the time there is a vast difference in price between generic and brand medicines so it would bring down the cost significantly. The quality of medicines imported/manufactured will improve. - Sherine

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It is better if the doctors when prescribing medicines will give the generic names rather than the brand names.  Unfortunately in our country, this is not a practice among many doctors even though this is clearly one of the Principles of rational drug use recommended by Prof. Senaka Bibile. He wanted the drugs to be essential, effective, safe and to be sold at affordable prices. We understand that at present, more than 15000 drugs under various brand names are available in the market whereas the essential number of drugs that we need according to Prof. Bibile, is around 1000. This is a serious problem to the patient. There is a need to control the importation of these drugs by the Government of Sri Lanka, while implementing the recommendations of Prof.Bibile. Also, if the doctors are requested to prescribe drugs in their generic names, then the chances of them being obliged to the multinational drug companies will become less. It is also time to seriously consider manufacturing our own drugs as we already have facilities. What is needed is the commitment and upgrading of the existing lab facilities. I believe rather than wasting time on passing health bills in parliament of which the public are clueless, it is better to implement the recommendations of Prof. Bibile which are still valid and even led the WHO to promote the use of his model in other developing countries. -

Subhashini

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Shiranthini

It's a good thing.  The Act is said to ensure the quality of drugs too. The choice to choose is ours as well. This will solve only part of the misery I have with our medical sector. It costs us so much TIME to see a doctor and get our medication. The GOSL should streamline all its hospitals, to avoid delays. They have the best of doctors, nursing care and the equipment. Who wants to be fleeced by the private sector, which is beyond my reach anyway. - Shiranthini

By Vajini H. Gunaratne