Unauthorised foreign drugs entering medicine markets

Foreign drugs are entering the country's local markets through informal channels due to lax monitoring and supervision, insiders have said.
According to them, though authorised agencies are allowed by the Directorate General of Drug Administration (DGDA) to import only registered medicines, about 20 to 25 per cent of foreign medicines enter the local markets through unauthorised channels.
"Most of the unregistered drugs are being brought into the country from India especially as  luggage," said a manager of a local medicine importing and distributing agency.
Preferring anonymity, officials of some medicine importing agencies told the FE though approval of the DGDA is mandatory to import medicines, some dishonest agencies or people are continuously bringing various kinds of unregistered drugs by adopting different illegal ways where they don't have quality guarantee and price policy.
Md, Ali Arshad, Manager, Regulatory of Suvro Limited, an importer of foreign drugs, told the FE that they import Albutein and Alfanet from Singapore which are certified by the US Food and Drug Administration (FDA).
He said these drugs are used for treatment of liver cirrhosis and burn diseases which have to be carried with great level of caution ensuring required temperature by frozen means.  
"We notice that such products are also being illegally imported from India by dishonest traders but this is risky as they cannot ensure such required carrying methods where quality is alarmingly hampered. Moreover, these products don't have authenticity and the customers are bluffed here by the suppliers", he added.
"Retail price of our imported 20 per cent 50 ml Albutein is Tk 3,200 and 100 ml is Tk 6,400 while 25 per cent 50 ml is Tk 3,809 and 100 ml is Tk 7,500. The price of Alfanet is Tk 8,200 while unregistered products may cost Tk 200 to Tk 300 less," he added.
He said dishonest traders use different techniques and mediums to supply these unregistered products by evading the DGDA watch.
However, Md. Wahedod Zaman, proprietor of the Medicine Fair, a local medicine and operations equipment parts wholesaler and retailer in the city's Mitford area, told the FE that such importers actually take the advantage as a significant number of Bangladeshi patients go to India for treatment where doctors prescribe them Indian medicines but those are not authorised in the country's local markets.
 "We can't sell such products as we strongly comply with the rules of the DGDA but we observe that if we offer same brands of the local companies, they prefer to have prescribed brand's drugs creating demand for Indian medicines in the local market and dishonest traders take this advantage," he added.
He also urged the DGDA to fully stop such imports or give registration to a few Indian medicines, especially anti-cancer drugs, which have demand in the local market so that they can also sell the products.
Talking to the FE, one of directors of the DGDA Ruhul Amin said about 98 per cent of the country's total medicine demand is being met by local companies where only two per cent is met by imported drugs.
He said around 900 types of medicines and devices are registered by the DGDA for import into the country," he added.
He said these imported drugs are actually hi- tech products which are supplied by the multinational companies operating in the country or their authorised local agents but if at least three local companies manufacture an item, the DGDA doesn't give registration for import of such an item.
"In this case, the DGDA has distinct policy and every entity which wants to import medicine must follow certain process," he added.
He said to be registered, first of all, the drug must be imported from at least seven countries of which one must be developed country. After that, it will go to the drug control committee where they scrutinise the drugs in terms of demand, quality, price and availability. Then it goes to the final committee and if this committee recommends, it will be registered.
"In this case, the DGDA also fixes the retail price in consideration of cost and freight and the importers must sell their registered products at this rate," he added.
When asked about illegal drugs he said the DGDA follows strict rules and never tolerates any irregularities in this important sector. But he admitted some dishonest traders adopt different techniques to import unregistered products.
"We continuously check and raid the country's different medicine hubs and if we get any unregistered items or irregularities, we seize such drugs and fine them," he added.
He said however such imports have been reduced to a great extent as the DGDA has undertaken some stiff measures to combat such intrusion.
However, Mr. Amin said the country's dependency on this insignificant import is also falling gradually as some leading local companies are also moving to produce hi-tech products which are being imported now.
The country's pharmaceuticals industry is almost self-sufficient and exporting medicines to more than 100 countries including highly-regulated markets of the USA, the EU, Australia and the GCC. In the fiscal years 2015-17, the country exported drugs worth $ 82.11 million.
    wazeddu@yahoo.com