Drugs, Standards and Control

In one line

The third thing medicine can get wrong is not the doctor or the hospital but the substance itself.

In the wording a student can write in an exam: the Drugs and Cosmetics Act 1940 regulates the product, by prescribing standards of quality, by defining and prohibiting the misbranded, adulterated and spurious drug, by requiring licensing of manufacture and sale, and by providing an apparatus of Government Analysts, Inspectors, sampling and prosecution; and it operates on the supply chain rather than on the clinical encounter, so it protects a population rather than compensating a patient.

Why the law has this at all

The patient is in the worst possible position to judge a medicine. They cannot see what is in it, cannot test it, cannot evaluate the claim on the label, and are frequently taking it because a person they trust told them to. Every assumption on which ordinary consumer law rests fails, for the same reason it fails in the clinical encounter, described in [The Doctor and the Patient].

Two consequences follow, and they explain the shape of the Act.

Regulation must be anticipatory. A defective drug cannot be identified by the person harmed, so control operates before the product reaches anyone: at manufacture, at import, at sale, and by sampling.

The wrong is committed against a population. One contaminated batch injures everyone who takes it, and each individual injury may be small, latent or indistinguishable from the disease. This is the diffusion problem from [Remedies When Technology Causes Harm], and it is why the Act is penal rather than compensatory.

The scheme

Section 3 contains the definitions, and three of them do most of the work: drug, cosmetic, and the categories that make a drug unlawful.

Standards of quality are dealt with by section 16, and the following sections define the three categories of unlawful drug that recur through the Act and through any answer on it:

The distinction matters because it locates the fault. A misbranded drug may be perfectly good medicine wrongly described; a spurious drug is an imitation of another product; an adulterated drug is corrupted in substance. An answer that treats them as three words for "bad drug" has missed the scheme.

Section 18 is the central prohibition. From such date as the State Government may fix by notification, no person shall himself or by another on his behalf manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale, or distribute: