[e-drug] DRA or FDA?

e-drug
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E-DRUG: DRA or FDA?
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Dear E-druggers,

Mongolia is considering to upgrade its existing drug regulatory unit to a
Food and Drugs Authority, with access to a joint Quality Control laboratory
and inspectorate.

Is anyone aware of lessons learned when moving from a DRA to an FDA?
Or has there been any evaluation or comparison between having an DRA or an
FDA?

Who should control biologically active products (now classified as food
supplements; they are not medicines as they have no evidence-based
indications; but they look like medicines and are sometimes promoted as if
they are medicines)

Should veterinary medicines be controlled by the DRA (as they are medicines)
or by the Food Authority (as they used by farmers to grow animals or produce
meat)?

And how to deal with possible conflicts of interest between a Ministry of
Health (protecting humans and public health) and a Ministry of Agriculture
(promoting more food production and supporting farmers)?

Your views or experiences, please!
You can write directly to wilbert@fhsdp.org or to E-drug if it is
interesting to all E-druggers.

Regards

Wilbert Bannenberg

---
Wilbert Bannenberg, team leader, 4th Health Sector Development Programme,
Mongolia
wilbert@fhsdp.org; Mongolia mobile +976-9592 5542; Skype: wilbertb1;
Blackberry PIN: 23b0da13
Mobile when outside Mongolia: +31 6 20873123; Mobile Fax +31 84 7135814
Office: MOH annex next to Springs Hotel, Ulaanbaatar, Tel +976-11-314147,
skype: FHSDP.FHSDP

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E-DRUG: DRA or FDA? (2)
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[The issue is about combining the activities of drug/medicine regulation with those of food regulation and under which arm or sphere of influence certain products should fall. For example the US FDA regulates food quality, packaging, recalls, etc. as well as medicines under two separate divisions. What are some of the lessons learnt in other countries that have moved to this model? Advantages, disadvantages e.g. in regulating food supplements, energy drinks, traditional medicines, baby formulas, animal feeds containing antibiotics, etc. Your views or experiences, directly to wilbert@fhsdp.org or to E-drug if it is interesting to all E-druggers. DB]

Hi,

DRA or FDA, the nomenclature does not matter as long as either is chosen and do its work sincerely.

Medicines, nutritional supplements indicated and advertised for health maintainance, restoration and therapeutic purposes; veterinary medicines, animal, mineral source, plant derived medicines, bioengineered products all should be under the FDA. And so should be all such manufacturing facilities.

In India, currently the pharmaceutical production facilities are under Ministry of Petrochemicals and Fertilizers. Different countries may be having such anamolies. May we know what is happening elsewhere?

Dr Vijay Thawani, India