Govt introduces new pharmaceutical importation system

…privileges brand-name medication
…more expense for ordinary citizens

A regional hub will now recommend approval for pharmaceuticals to be imported into Guyana and other member States.
The Caribbean Public Health Agency (CARPHA) will HOST the Caribbean Registration System (CRS) – a body established to assess drugs for importation into various Caricom countries. This is according to Government Analyst-Food and Drug Department (GA-FDD) Head, Marlan Cole.

The measure was signed by Public Health Minister Volda Lawrence on March 3, 2017 without consultation with stakeholders.
But even as Cole made the new measures known, local importers are up in arms over the move, which will now be more favourable to large foreign companies, such as Ansa Mcal.
This newspaper was told that this new measure will now mean that majority of generic medicines, from India, China, Brazil will now be banned from entering Guyana. This according to one local importer will mean additionally expenses for ordinary citizens since only costly “brand-named” medicines will be permitted in the country.
Previously, suppliers would have submitted dossiers to local regulatory bodies for review and approval of the drugs they wanted to sell on the market.
With the new system in place, suppliers will now have to make electronic submissions to the CRS, for it to peruse and do an assessment of the drug.
Following the assessment, the CRS would make recommendations for that drug to be registered in the respective territory.
In Guyana’s case, Cole told reporters during a public meeting with drug importers at Cara Lodge on Tuesday, the CRS is using a system of reliance whereby it would depend on the certification from either a World Health Organisation (WHO) prequalified site or the particular medicine’s marketing authorisation issued in Canada, the United States, the United Kingdom, Australia, Argentina, Cuba or Mexico.
“They now would do an assessment based on WHO format of assessing the drug and ensuring there is all the checks and balances as it relates to the drug bioavailability, dissolution test, acid test, disintegration test,” he explained.
Cole continued, “And then they would make a recommendation to the member states and then you have a sovereign right now to issue or not to issue a market authorisation.”
In addition to that objective, the CRS has other mandates, Cole noted which includes to conduct assessments for rapid review of dossiers, assessments to make generic drugs available on the market and pharmacovigilance as it relates to adverse drug reactions in order to keep checks on drugs that are spurious, falsely labelled, substandard, falsified or counterfeit.
Moreover, Cole further explained that the CRS project would only deal with generic drugs at this point in time.
“They will be strictly focusing on generic…they will be concentrating on drugs that are on the essential drug list in the Caribbean, drugs that are for HIV, malaria, TB, and drugs that would have been prequalified by the WHO, so that is their criteria,” he stated.
“So, if you come with a drug that is a brand name drug; they (CRS) would not be assessing those currently. We (Food and Drug) would have to continue to; if you have a brand name drug, we would have to still continue our methodology of trying to do an assessment.”
Addressing concerns about the implications of this new project on the importation of drugs from major countries like India, Cole assured that there would be no adverse effects.
He explained that most of the generic drugs were manufactured in India and most of the manufacturing sites were prequalified by WHO, or they were manufactured on behalf of companies in countries that can do full assessment.
He warned, however, of some concerns when it comes to importing drugs from India.
“The issue with India – this is listed anecdotally and this is not proven or tested – [there is] in excess of 3500 clandestine operating facilities in India, or sometimes they say it is more than that. So, in order to safeguard your society against those facilities, you depend on them being either certified by one of the ABC countries, WHO or in some cases, Argentina, Mexico and Cuba,” he explained.
He noted too that the CRS was relying on documents and certification from Cuba, Mexico, Argentina and Brazil as well, so drugs could come from those countries.
Company favoured
However, Former Health Minister, Dr Leslie Ramsammy, in a letter to the press, has pointed out that by design this new policy benefits Ansa McAl since this Trinidadian-based company represents several branded drug companies selling their products at exorbitant prices, which was publicly exposed in the recent Georgetown Public Hospital Corportaion (GPHC) sole-sourcing fiasco.
Dr Ramsammy pointed out that not registering a generic medicine in America does not automatically mean that these medicines are inferior. “For many non-US, non-Canada, non-UK generic companies, the high cost of meeting the barrage of ever changing import barriers designed to protect American, Canadian, British pharmaceutical companies make marketing low-cost medicines in those markets uneconomical.”
He added that it is noteworthy that citizens from America, Canada, the UK, Europe and other countries travel to India to procure medicines because they cannot afford to purchase these medicines in their own countries. The Caricom Ministerial Body for Health gave its approval to implement the CARPHA CRS programme in 2014.