FDA Act bans unregulated imports of vaccines

IN light of a Fyzabad businessman's claims of the private importation of covid19 vaccines – a claim since scotched by Commissioner of Police Gary Griffith – Newsday inquired into the laws regulating such imports, plus the penalties for any breach of these restrictions.

The Food and Drug Act (FDA) sets down stringent specifics.

Newsday asked Health Minister Terrence Deyalsingh which laws might be broken by someone claiming to offer efficacious, safe and hygienic vaccines to the public, if in fact these were not officially validated by state agencies.

Deyalsingh replied, "The CMO addressed the issue at the press conference. Please refer to his statement," referring to the ministry's briefing on June 2.

At that time Chief Medical Officer Dr Roshan Parasram said, "In terms of the legal consequences, it's an importation issue. It may be a breach of certain aspects of the FDA Act.

"But I don't want to pronounce on it. It really is a matter for the Attorney General and the Ministry of Legal Affairs. Once the (health) ministry picks up a breach, we send it to them and that part of it will be determined by that ministry (AGLA.)"

Up to press time AG Faris Al-Rawi had not replied to a query for details.

Newsday asked Deyalsingh his advice to anyone who was offered a non-approved vaccine by private individuals.

In a text to Newsday he advised the public, "Only take WHO-approved vaccines offered by the Government. At this time no private-sector entity has applied to import any vaccine."

Newsday asked what action would the Government take if any dubious import of vaccines ever occurs in the future.

He replied that any information coming to him about such imports would be dealt with in the strictest confidence, and then: "The appropriate investigation would be launched to protect the public's health."

The FDA Act gives the Minister of Health general oversight on the quality of items of food or drug being supplied for personal consumption, plus cosmetics.

The minister can order anyone whose business includes the "production, importation, or use" of specific substances to notify the minister of the composition and use of these.

The minister may require details of the composition and chemical formula of the substance, plus how it is used in the preparation of a food, drug or cosmetic. The person must also disclose any investigations into how the substance, or any product formed from it, may harm human health.

Section 4 restricts people from claiming to offer cures for maladies. It likewise bans anyone selling such items.

The act also sets down more specific conditions for handling food, drugs, cosmetics and devices respectively.

Sections 9-13 regulate the sale of drugs, including vaccines ,some of which the bill later on lists among thousands of drugs newly approved by the minister acting on the advice of the Drug Advisory Committee.

The law prevents the contamination of drugs in section 9. It also bans the false advertising of a counterfeit drug, in Section 10. The law insists drugs be kept under hygienic conditions, in section 12.

The FDA Act sets down penalties for violations in section 33.

"Every person who commits an offence under this act is liable on summary conviction for a first offence to a fine of $1,500 and to imprisonment for three months, and for a subsequent offence to a fine of $3,000 and imprisonment for six months; and on conviction on indictment to a fine of $15,000 and to imprisonment for three years."

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