– foresee adverse effect on business
Following the introduction of the new measure whereby a regional hub will now recommend approval for pharmaceuticals to be imported into Guyana, local importers had mixed reactions to the new system with many of them decrying the move, saying that it will “adversely” affect their business.
The new arrangement – which was signed on to by Public Health Minister Volda Lawrence since early March and announced by Head of the Government Analyst-Food and Drug Department (GA-FDD) Marlan Cole on Tuesday at a public meeting with local importers – will see the Caribbean Regulatory System (CRS), a regional regulatory body under the Caribbean Public Health Agency (CARPHA), vetting and recommending pharmaceuticals to be imported into Guyana.
According to Cole, previously suppliers would submit dossiers to local regulatory bodies for review and approval of the drugs they wanted to sell on the market, but with the new system in place, suppliers will now have to make electronic submissions to the CRS for it to do an assessment of the drug.
He added that the CRS would then make recommendations to the GA-FDD as to whether that drug should be registered locally based on 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.
However, local importers are up in arms over the move, claiming that it would more favour large foreign companies, such as ANSA McAL. In fact, this newspaper was told that this new measure will now mean that the majority of low cost generic medicines – from India and China, among other countries – will now be severely curtailed or restricted from entering Guyana. This means the ordinary citizens would have to incur additional expenses since only costly “brand-name” medicines will be permitted into the country.
When contacted on Wednesday, Mike’s Pharmacy Chairman Lakeram “Mike” Singh related that while he was not present at Tuesday’s meeting, he had a representative there and based on what was relayed to him, the new system “looks detrimental in the long run”.
Nevertheless, this publication spoke with the company’s Pharmacist, Radha Rooplall, who attended the meeting and she explained that one of their regular suppliers is an Indian company and with this new regulation, there are new criteria to obtain marketing authorisation.
“So that (new) criteria now makes it difficult for us to register our products from the Indian company, because it’s from India and we would now have to check to see if (those products and the Indian company) would meet those criteria,” she stated.
Another issue that Rooplall pointed out they now face is the uncertainty of approval for shipments of pharmaceuticals that are already on the way from those companies. She indicated that this issue was raised at the meeting, and they were told that the marketing authorisation for some of those registered products would have to be reviewed.
“Remember we have been bringing in products from this company for many years, and we have already marketing authorisation for some of the products, so they are saying we can recall that and review it… So, I don’t know what will be the future in terms of importing drugs from India, but we would have to wait and see,” the pharmacist asserted.
Moreover, Rooplall went on to say that Cole had indicated to them during Tuesday’s meeting that the CRS would only be accepting drugs that were coming from the ABC countries, which would obviously be more expensive.
“So, we would have to work with whatever they are approving… If they don’t give us approval to ship those generic drugs from India, then probably we will have to seek alternatives,” she noted.
Meanwhile, MediCare Pharmacy Managing Director Aneesa Bacchus told this newspaper that her company would not be directly affected by the new system since it bought its supplies locally. However, she added that there would be a transferred effect if their suppliers (other local importers) were affected.
“We’re a retailer, so we wouldn’t be directly affected, but if the importers are adversely affected by this new measure, then we will also be in at the end. And customers will be affected at the end too,” she stated.
Meanwhile, Former Health Minister, Dr Leslie Ramsammy, had 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 Corporation (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. A few Caricom countries including Jamaica, Barbados and Trinidad and Tobago have refused to be part of this progrmme.