National Drug Regulatory Authority Bill: An insight

26 March 2015 04:30 am - 0 - {{hitsCtrl.values.hits}}

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The National Drug Regulatory Authority Bill was subjected to an evolutionary process before it was passed in Parliament recently. The long fight to instil justice in the field of pharmaceuticals was won by Dr. Senaka Bibile who was the founder of the Senaka Bibile Essential Medicines concept. Up until now, this policy was amended to be what it is today. However, since the enactment of this new policy was part of the 100-day programme under the good governance regime, its contents and the potential benefits to patients were not broadly highlighted. Therefore, in order to get a clear view of its contents and the potential benefits, the Dailymirror spoke to Professor R. L. Jayakody, Professor of Pharmacology of the Faculty of Medicine, University of Colombo.

Drug Regulatory Authority (DRA)
“Before looking at the existing legislature, and, if we look at the previous Bill, it was called the Cosmetics, Devices and Drugs Act which was brought about in 1980. Since the word drug is used for substances such as heroin, we have stressed on medicines or pharmaceuticals. The DRA has numerous functions. The area of medicine includes medical technology and supplies, medical devices and so forth... but its focal point is pharmaceuticals. Materials such as cosmetics are mostly chosen by the people to improve their appearance rather than being prescribed by a doctor.”

New criteria
“If you look at the criteria for evaluating drugs, we are a big importer of them. A majority is imported on a regional level. We have two sources from where we get medicines where they are either imported or are manufactured locally. So we need to look at the quality, storage, distribution, wholesale/retail price, pharmacies, surplus medicines being brought, outdated and discarded stocks. When taking the field as a whole, there are numerous activities to be regulated. Through this act we may have probably strengthened these regulations.”

Pharmaco-economic analysis

“Throughout the world, there is a criterion for registering medicines. Here we need to look at the safety, efficacy and quality of the medicine. In addition to these aspects, we have also included the cost of medicine and the need of the products to the country. On the other hand, we have also brought in the economic dimension to the country and we have conducted a pharmaco-economic analysis. Some doctors complain that certain brands are quite expensive. So through this Act we have given an opportunity to the companies to tell us the prices.”

Involvement of the Consumers Affairs Authority (CAA)
“When considering the prices of the pharmaceuticals, we have spoken to the CAA to be a part of the pricing. But they have told us that under the present legislature they cannot contribute any input to the initial pricing of pharmaceuticals. However, if there is a revision of prices, they will request for a reduction in the pricing. Also in this new Act, we have given authority for them to ask the price. We have included a bracketing range, for example, a certain tablet could be between Rs.1 and Rs. 3, so they can mark their price within this range and not above it. If so, the authority can oversee these monopolies and have a range of reasonably-priced products.”

Appeal committee
“Previously there was no formal party involved in the Appeal Committee. The new Committee includes a retired Judge from the Court of Appeal and a Senior Medical Consultant. If either a pharmacist or a consumer is not satisfied with the product, he/she can make an appeal to the authority. Also there are other routine aspects such as prohibition and prescribing which we have included.”

Generic name versus Trade name
“In my understanding, we need to look at the market. There are certain drugs which have patent holders, and therefore they maybe priced higher. Therefore, if the practitioners prescribe these, it will be quite costly for most people. There is a large range of products that come with the trade name, which may have a lower price compared to the initial price. Since there is a large volume of drugs, exclusively writing the generic name will not be acceptable for a doctor’s profession. Therefore we included a clause asking the practitioner to write both the trade name and the generic name. So when somebody wants to purchase a drug, the pharmacist can tell the range of drugs available and then he/she can buy the drug that he/she can afford.”

When will the Bill be enacted?
When asked about how soon the Bill would be enacted, Professor Jayakody mentioned that the Committee too has the same question. “The Honourable Minister should first set-up the authority now and afterwards we can form the regulations to cover the necessary areas.”

What happened to the amendments?
At the time the Bill was being presented in Parliament, many politicians brought in Amendments for the benefit of the people. However, the Daily Mirror found out that these Amendments were not entertained. Speaking on this issue of Amendments, Professor R.L. Jayakody said, “Some Amendments cover what we have already mentioned, and therefore, we didn’t take them up. Certain others were proposed for the benefit of certain Committees, and therefore, we were not much in favour of them either. Some of the Amendments cover the Essential Medicines concept and this exists at all hospitals. So there was no need for us to insert another additional clause.”

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National Drug Regulatory Authority Bill: An insight

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