In several countries, the term ‘counterfeit drugs’ has come to represent poor quality medicines and is used in common parlance, although there are major differences in definitions. On account of these differences, there is a great difficulty in exchange of information between countries as well as in estimating the global problem of poor quality medicines. To address this concern, in 2009, the WHO came up with a definition that was considered by many to be broad and ambiguous. A broad definition often creates confusion between legitimate generics and dangerous fakes—therefore, it has been suggested time and again that the term ‘counterfeit’ should not be used in the context of medicines. Responding to the above criticism, during the 63rd World Health Assembly, it was proposed that until a consensus is reached on how poor quality medicines are defined, the acronym—substandard, spurious, falsely-labelled, falsified, counterfeit medical products or SSFFC—be used. This has given rise to yet another challenge for defining poor quality medicine, as anything in SSFFC becomes everything in SSFFC.
There have been several reports of spurious medicines in the Indian market and in order to map the magnitude of this problem a study is currently ongoing under the aegis of the National Institute of Biologicals, which promises significant improvements over earlier surveys. A recent study undertaken by the authors found that depending on how poor quality drugs are defined and how these definitions are interpreted, all these surveys may not be talking about the same category of drugs. To put forth a clear picture, a brief description of the composition of a medicine is required.
A medicine primarily comprises of two components—the active pharmaceutical ingredient or API (the substance behind the therapeutic effects) and the excipients (substances required to facilitate the administration, preservation and absorption of the API by the body). These two components are then formulated together to give the medicine a final pharmaceutical form (tablets, capsules, syrups, etc). Modifications with respect to the dose of API, the type of an excipient and the formulation are brought about to bring a desired change in the therapeutic response (for example, immediate release or sustained release, etc). A truly legit medicine would contain the right dose of the correct API along with an excipient as enlisted on the packing, along with the true identity of the manufacturer. A wrong dose of the correct API or a right dose of the incorrect API would make it either a substandard/not of standard quality (NSQ) product or a spurious product, while the pack label may further decide the nomenclature of the medicine.
The Drugs & Cosmetics Act 1940 (DCA) does not mention the terms counterfeit, substandard or falsified drugs; instead, the terms misbranded, adulterated and spurious are mentioned in Sections 17, 17A and 17B of the Act, respectively. In India, the term ‘counterfeit’ is attributed with a narrow legal sense, i.e. wilful trademark infringement as defined in Trade Related Aspects of Intellectual Property (TRIPS) documentation. In India, if a legit manufacturer wilfully chooses to label its product with someone else’s trademark, only then the product is deemed to be a counterfeit (a category of spurious drugs). In case the manufacturer chooses to label its product without revealing its identity and source, the same may be referred to as a spurious drug, but not a counterfeit. Subsections (a) (b) and (e) of Section 17B of the DCA, which defines spurious drugs, effectively subsume this narrow legal definition of counterfeit drugs. Hence, counterfeit drugs are equivalent to spurious drugs, but spurious drugs are not just counterfeits but other fake products as well.
Another important issue is that of absence of a clear distinction between spurious and substandard drugs. A distinction between ‘substandard/NSQ drugs’ and ‘spurious drugs’ as two separate classes based on the DCA should come under scrutiny because the interpretation of these terms is not uniform across states—they are distinguished only after an investigation by a drug inspector. In some cases, the starting point of this investigation is the presence of the word ‘substituted by’ in Form 13, i.e. drug test report issued by a government analyst in a government drug testing laboratory. The term ‘substituted by’ acts as a surrogate to establish the intent of the manufacturer (in a case where the API is found to be in deviation with the prescribed pharmacopeia standard), distinguishing it from a lapse in quality assurance or poor handling. A product with 0% API is referred to as spurious, while a product with even 1% can be considered as grossly substandard depending upon the contents of Form 13 provided by a government analyst.
For most people outside the regulatory sphere, the terms ‘spurious’, ‘counterfeit’, and ‘substandard’ are synonymous with ‘fake drugs’. Making these distinctions have a strong bearing on pinpointing the true extent of the problem of poor quality medicines in any country. Hence, it becomes all the more necessary to bring factual clarity in terms of the nomenclature of poor quality medicines as defined under the SSFFC framework. It is important that policy-makers pay heed and stress upon including a clear description of SSFFC terms in any ongoing or future studies instituted to quantify the extent of poor quality medicine. This is not the same as redefining quality of medicine or bringing in new terms, instead merely an appeal to remove obscurity from this important conundrum.
This article draws upon the authors’ ICRIER working paper Drug Quality and Safety Issues in India