White-paper: Unlicensed Drugs VS Counterfeit Drugs

    1. What is the difference between unlicensed and counterfeit drugs?

      A.Un-licnesed drug : This is a drug which is not available in the UK due to low disease incidence

      For Example : Prevalence of Tuberculosis is low in UK so many drugs related to Tuberculosis are not licensed by MHRA in UK.

      If a pharmaceuticals wholesaler from the UK authorised by MHRA for imports of “Specials” imports such an unlicensed drug – it’s called Import of Unlicensed.

      Unlicensed here means – not licensed by the MHRA for general sale in UK.

      B.Counterfeit – As the term implies : this is a counterfeit or a fake of the original.

      For Example : Viagra is a original brand and if someone other than the Trademark owner tries to manufacturer and sell Viagra it’s called a Counterfeit.

    2. Why do people sometimes confuse the term and think they are the same thing?

      These terms are technical and industry specific, not commonly used in public domain, hence the confusion.

    3. Do you think that unlicensed and counterfeit drugs are an issue?

      Unlicensed drugs are not an issue, this is a very well regulated industry with close to £ 250 million worth of drugs being imported to UK each year.There are specialised importers in the UK authorised by the MHRA to conduct this business.

      Counterfeit is an issue : This is an unregulated industry operating away from the sight of law enforcement.

    4. What can be done to stop this from happening?

      With a advent of internet, online pharmacies, Bit coin payment, there’s very little the regulators can do. If they close one door, 10 others are opened by racketeers.

      The best possible solution is creating Public awareness – stay away from purchasing medicines from Un-known websites.

    5. Are drugs exported to the UK substandard?

      Drugs officially exported to UK comply with quality standards set the by MHRADrugs imported through illegal channels into the UK have no control and quality is anyone’s guess.

    6. What are the Indian Government doing to address the issue of drugs that could potentially be unlicensed:

      Indian Government: Official exports : Unlicensed :The government of India has made in Mandatory for all pharmaceuticals being exported from India to carry Secondary and tertiary level barcoding as per GS1 protocols. (Global Standards 1).

      At the ports : An export channel has to be followed which involves clearing the drugs through Indian customs and opening a export declaration (Called Shipping bill in India)

      After clearance from Indian customs the drug data has to be uploaded on DAVA Portal – a joint venture with GS1

      This portal captures every details of the drug being exported and is accessible to industry, institutions and governments.

      counterfeit?

      To stop the production of Counterfeits – Government has stepped up Factory inspections and product based permission whereby each product being manufactured in a particular factory has to have license from local Drug office.

      India is actually a victim of Counterfeit – these drugs are manufactured in some other countries but sold with Indian labelling.

      Counterfeits do not follow customs channels and move through human carriers or regular post parcels as personal items.

    7.  Are unlicensed or counterfeit drugs for erectile dysfunction being sold to people in the UK?

      Erecticle dysfunction drugs to not fall under Unlicensed category as several brands have been licensed by the MHRA for UK market.

      But yes, if someone is buying these drugs from online pharmacies there’s no method to ascertain their genunity and hence these can be termed as counterfeit.

    8.  If not, then could someone put a fake label on drugs saying made in India, for example?

      Yes, its not difficult to print a pack or outer carton in Malaysia which read’s made in Thailand.

      Similarly it’s not difficult for the counterfeiters to print a packs and mention any origin they like.

      Currently India is their favourite

 

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