Drug suppliers to Ministry now have to provide manufacturer’s authorisation

Suppliers of pharmaceuticals to the Ministry of Public Health (MoPH) will now have to provide an authorisation from the manufacturer of their drugs when bidding for state contracts, the Ministry yesterday announced.

“One very important measure taken to enhance the efficiency of the evaluation of bids and other due diligence processes is to now request for each of our pharmaceutical and medical suppliers to submit recent Manufacturer’s Authorizations offered to them,” the Ministry stated yesterday in an advertisement placed in state-owned Sunday Chronicle.

Calling the decision one of “major changes to the way business is conducted with suppliers of pharmaceuticals and other medical supplies”, the MoPH said that the instruments of authorization are intended to expedite the verification process during the Evaluation period and also to mitigate against any uncertainty.

According to MoPH, a recent Manufacturer’s Authorization or marketing Charter Agreement is considered to be one which is an original parchment of the manufacturer and is dated no earlier than six months from the date it is submitted.

Last year, Minister of Public Health Volda Lawrence signed a Memorandum of Understanding with the Caribbean Public Health Agency (CARPHA), in keeping with commitments the former government had already made in 2014, to pave the way for the implementation of the Caribbean Regulatory System (CRS).

The CARPHA/CRS requires that the medicines it examines have already gone through rigorous regulatory scrutiny, and are approved by a trusted regulatory entity, such as the US Food and Drug Administration, or the Brazilian Authority, ANVISA. It also requires that the medicines it accesses are listed on the WHO Essential Medicines List, most of which are generic.

Head of the Government Analyst-Food & Drug Department Marlan Cole has consistently lamented the need for the vigilance on not only food but the quality of drugs being imported and has hailed the establishment of the CRS.

He believes that will ensure that patients in Guyana and other Caricom countries will have access to generic drugs that are safe and of a high quality. The agency will serve as a support system here for the GA-FDD, he explained.

The CRS website states that the agency’s main purpose is to strengthen regulatory capacity in Caricom member states in support of improved access to safe, quality, efficacious, and affordable medicines and health technologies.

“The CRS strengthens regulatory capacities through the provision of registration and pharmacovigilance support to member states, using efficiencies, such as reliance on reference authorities, to enable a sustainable enterprise in the resource-constrained environment of small states. This contributes to CARPHA’s mandate to prevent diseases, promote health and respond to public health emergencies,” it adds.

Cole pointed out that over the years, there have been complaints by persons in the healthcare fields, in many Caricom countries, that there was limited resources to check the quality and efficacy of drugs brought in.

“What the region recognised is that per country, no one had the resources needed to check the drugs coming in. So it was decided that a hub be created and the CRS will look at drugs for all other regions,” he noted.

The GA-FDD Director has also bemoaned that it was not only fake products he has to deal with daily but forged documents.

“We have people bringing forged documents to us, all these things we have to deal with,” he said.

And while expired and fake foods are troubling for the GA-FDD, the issue of counterfeit and placebo drugs only exacerbates their troubles.

Cole pointed to some drugs, such as the prescription pain reliever Voltaren, which has seen counterfeits popping up in pharmacies across the country. He said it is only one of a myriad list and the department can only do so much at a time to investigate and take them off the shelves.

The Ministry of Public Health has said that it had also received reports of persons waking up during surgery from substandard anesthetics provided.

Pharmaceutical supply companies that bid for ministry contracts have until May 25, 2018 to produce the documents and submit them to the Permanent Secretary of the Ministry of Public Health, Brickdam, Stabroek, and Georgetown.

 

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