The World Health Organisation (WHO), in December 2008, proposed the following new definition, as prepared by the International Medical Products Anti-Counterfeiting Taskforce (IMPACT):“A medical product is counterfeit when there is a false representation in relation to its identity and/or source. This applies to the product, its container or other packaging or labeling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.”This definition, indeed, created a furor in India. The Ministry of Health of the Government of India initiated discussions, on this issue, with the stakeholders and by mid-January, 2009 a consensus was arrived at between the Drug Controller General of India (DCGI) and the generic industry on much debated definition of counterfeit drugs. It was reported that the Government had decided to place this definition before the World Health Organisation (WHO) in its next meeting on the subject. The consensus definition, after the above meeting, was reported as follows:

“A medical product (medicine, vaccine, diagnostics and medical implants/devices) is counterfeit when it is deliberately and fraudulently mislabelled with respect to its identity and/or source. Counterfeit can apply to components with wrong ingredients/components without active ingredients, with incorrect amounts of active ingredients, or with fake package”

In end-January 2009, although it was reported that under pressure from the developing countries like, India, WHO has dropped this new definition, it is very likely that the initiative is now just on a ‘pause’ mode.

Let us now try to explore the ‘Eye’ of this stormy debate and its relevance to India. The ‘eye’ of the storm lies mainly within the following 3 key concerns of the opponents of the definition:

1. False representation of identity and source applies not only to labeling but also to the ‘product,
its container or other packaging’
2. The new definition could include Intellectual Property Right (IPR) issues and as a cosequence of
which, Indian generics could run into the risk of being branded as counterfeit
3. Removal of the words ‘fraudulent and deliberate’ from the original definition and replacing them
with ‘false representation’ will shift the burden of proof

In India, the share of voice of those opposing this definition was undoubtedly much more than those who were supporting it. However, the rationale for supporting the definition, in Indian context, appears to be much stronger than opposing it.

While arguing on this point, I am of the view that most of the apprehensions expressed above have been abundantly clarified in the definitions of Misbranded drugs (section 17), and Spurious drugs (Section 17 B) of the Indian Drugs and Cosmetics Act, 1940.

Let us now have a quick look at the Section 17 and Section 17 B of the Drugs and Cosmetics Act to find out whether the WHO IMPACT definition is way off the definitions for Misbranded and Spurious drugs as indicated in the above Act.

“Section 17. Misbranded drugs – For the purposes of this Chapter, a drug shall be deemed to be misbranded –

(a) If it is so coloured, coated, powdered or polished that damage is concealed or if it is made to appear of better or greater therapeutic value than it really is; or

(b) If it is not labelled in the prescribed manner ; or

(c) If its label or container or anything accompanying the drug bears any statement, design or device which makes any false claim for the drug or which is false or misleading in any particular.”

Does Section 17 of the Drugs and Cosmetics Act, 1940 answer the ‘concern 1’ above?

“Section 17B. Spurious drugs – For the purposes of this Chapter, a drug shall be deemed to be spurious

(a) If it is manufactured under a name which belongs to another drug; or

(b) If it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) If the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) If it has been substituted wholly or in part by another drug or substance; or

(e) If it purports to be the product of a manufacturer of whom it is not truly a product.”

Does Section 17B of the Drugs and Cosmetics, 1940 Act answer the ‘concern 2′ above?

The ‘concern 3’ above deals with shifting the ‘burden of proof’ with replacement of the words ‘fraudulent and deliberate’ by ‘false representation’. Many legal experts opine that this change will only mean that “criminal intent (fraudulent and deliberate) shall be considered during the legal procedures for the purpose of sanctions.”

What could then possibly be the reasons for opposing the revised WHO IMPACT definition of Counterfeit Drugs in India, especially when we have similar definition in place in our own Drugs and cosmetics Act, 1940? Does it make sense for the Government to reinvent the wheel? Who knows?

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.