Counterfeit products are a growing problem for businesses all over the world, resulting in huge economic losses and possible harm to consumers. The effects of counterfeiting are felt in almost all industries, but the one in pharma and the food industry, it can be life-threatening and henceforth, needs to be tackled critically. In the pharma industry alone, the lack of regulatory standards and inadequate enforcement have allowed the growth of spurious drugs to alarming proportions. This intentional and calculated reproduction of a genuine product misleads the recipient/buyer into believing that he/she is receiving the genuine article. Thus, manufacturers of such articles profit by misusing the trademark benefits of the original brand by sales of the fake drug. In fact, some companies have estimated fake drugs to account for one-sixth of the total sales turnover of their popular brands. What defines counterfeit products? The definition of SFFC drugs (spurious/ falsely-labeled/ falsified/counterfeit drugs) varies from country to country and in general, the use of such drugs may lead to treatment failure or even death. In India, under the Drugs and Cosmetics (Amendment) Act 2008, any drug is deemed to be adulterated or spurious if when used by any person for, or in, the diagnosis, treatment or prevention of any disease (or disorder), it is likely to cause their death or cause harm on their body. SFFC medicines are also defined as ‘medicines which are deliberately mislabelled with respect to identity and/or source, and which may include the products with correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging.’ In India, as per the Drug and Cosmetic (D and C) Act, 1940, poor quality drugs are segregated as either a) misbranded, b) spurious, or c) adulterated drugs. With the 2008 amendment of the D and C Act, the Indian drug regulatory authority, Central Drugs Standard Control Organization (CDSCO), has categorised the ‘not of standard quality’ (NSQ) products in three categories A, B and C. This categorisation is very important and is helpful during quality evaluation. Measure ingredients that can be found in spurious drugs are:
- Heavy metals
- Poisons
- Common household items
- Other low-cost medicines
- No medicine at all
Undoubtedly, the effect of such ‘medicine’ on the consumer can be adverse since it does not cure the disease at all, and may even worsen the state of the patient. Unfortunately, this is how patients or their doctors become the first identifiers of fake drugs.
Damage to the society: Spurious drugs not only damage companies by loss of sales, but they also tarnish their image and the reputation of their brands. The consumer gets cheated, as spurious drugs do not treat the ailment and consumer continues to suffer. In critical cases, this could even be life-threatening. Besides the company and the consumer, the government also suffers revenue loss, as manufacturers of spurious drugs do not pay any kind of taxes. Likewise,since trade the spurious drugs trade largely goes unaccounted for, those selling these drugs also do not pay the tax thereon.
Control over the expansion of spurious drug industry: The union health ministry has issued a draft notification to amend the Drugs & Cosmetic Rules 1945 to stop unqualified ‘pharmacists’ from dealing in wholesale and in the distribution of drugs.
Only registered pharmacists will be able to deal with the supply and storage of medicine for distribution to retail pharmacy outlets. This was not the case until a few decades ago. Previously, the government used to receive several complaints of spurious, adulterated and misbranded medicines being supplied by distributors to chemist shops. To arrest this issue, the government
- Has increased NABL accredited lab for drug testing
- Worked on implementation of track and trace, which got an extension till 1st July 2019
- Is in the process of drafting a policy for e-pharmaciesMade a policy of compulsion of three months of stability for all the new product launches in local markets.
However, there is still a large grey area that the government has to deal with for a problem as complicated as fake drugs. There is an urgent need for time-bound decisions on legal cases against fake drug manufacturers, sales and distributors. There is also a need for special courts for timely and speedy disposal of such cases.
Role of supply-chain: Most of the adulteration and the misbranding is done during distribution. There is a need for the supply of counterfeit medicines to be checked at pharmacies. There have been many instances across India that drug dealing posts run by unskilled persons were found to be involved in malpractices, especially in wholesale markets of Agra, Patna, Bhagirath Place (in New Delhi), Maharashtra, Gujarat, Chhattisgarh, etc. Deputing a trained pharmacist may halt the supply of fake drugs at the distribution point itself.
Complaint evaluation – in-house standard operative protocols (SOPs): Generally, the complaints are received through the distribution or the marketing departments in a company which then undergo evaluation process depending on their SOPs. Usually, the standard process is as follows: At first, the complaint is forwarded to the CQA / QA department which does
1. Review
2. RM / PM analysis
3. Report /Findings
4. Conclusion
5. CAPA
Next, the RM analysis may reveal the following possibilities:
1. API is the same as original but of low potency or strength
2. Some other API, albeit non-harmful, is used
3. API is toxic and adversely affects the consumer
4. No API is used and only placebo is used
An RM analysis, to some extent, can help to understand the source of the API used in the fake drug, thereby helping in identifying its primary source. Then, PM analysis is carried out on primary and secondary packaging material thoroughly. Based on that, a comparative can then be made based on observation, in reference to:
1. GSM ,CALIPER , GRADE OF PAPER
2. Dimensions
3. In case of base films of PVC / PVDC, IR spectra can be compared
4. Make of tubing in case of glass ampoules
5. Type of glass/plastic used
6. Colour differences in both packs
7. Text, fonts, inks and varnishes used
8. Printers identification marks on the secondary, etc
Various departments involved may be QA, QC, production, packaging development, legal, and administration. The manufacturer can then register a police complaint and depute an external agency like a private detective to reach to the guilty and evaluate the root causes. However, in many cases, it is difficult to find the source of the spurious drug and hence, there is a need for corrective actions and preventive measures to avoid the damage as much as possible.
Preventive measures which may help drug firms
1. Registration of trademarks is an important step in protecting your brand
2. Taking help of the police department and the government agencies to identify the suppliers of spurious drugs
3. Implementation of technology
4. Educating consumers about your brands
5. Following a stringent process of vendor evaluation. The RM/PM vendors must be qualified and updated with GMP practices
6. Packaging plays the most vital role — A well-designed pack will be difficult to copy. As long as counterfeit products continue to damage brands and harm consumers, the anti-counterfeiting labels and the packaging market will continue to grow and evolve. One of the first steps that brand owners can take towards protecting their brand is to learn about various anti-counterfeiting techniques.
Anti-counterfeit labels and packaging techniques: There are mainly two types of anti-counterfeiting techniques for labels and packaging which are often used together to create a comprehensive security solution. Overt and covert features and hidden details make it easier to detect fakes and increase traceability across the supply-chain, and makes it harder to counterfeit products.
1) Track And Trace: 2D Barcodes — A two-dimensional (2D) barcode looks like a square or rectangle and contains many small, individual dots. The two most popular types are Quick Response (QR) Code and DataMatrix, but there are other options available. According to GS1, “A single 2D barcode can hold a significant amount of information and may remain legible even when printed at a small size or etched onto a product. 2D barcodes are used in a wide range of industries, from manufacturing and warehousing to logistics and healthcare.”
2) Watermarks: Watermarks are images or patterns that are embedded in the design of a package or paper to authenticate products and support brand identity. Watermarks can be generic or customized using a logo, brand name, or other symbology.
3) Microtext: Like watermarks, micro text is used to authenticate products. Extremely small text, codes, or symbols are very hard to replicate or copy without using advanced detection and printing equipment. Microtext can be inserted into overt images, larger text, and other design elements without being noticeable to the naked eye. Since micro text is indiscernible, counterfeiters would be unaware that it exists or where to look for it.
4) Holograms: A hologram is a three-dimensional image formed by the interference of light beams from a laser or other intense light source. Hologram technology is popular for anti-counterfeiting because it can incorporate various data forms and product tracking information.
5) RFID Tags: Radio Frequency Identification (RFID) technology uses radio waves to automatically identify people or objects.
6) Tamper evident seals with consolidated label
Tamper evident seals can be printed in different styles to fit your security and packaging needs. At the consolidated label, we can print shrink sleeve labels with a perforated seal or shrink bands.
Commonly known as ‘shrink sleeves’, these full-body labels make products stand out with visually attractive graphics that completely wrap around a container. They’re more than a pretty face — they’re harder to counterfeit than pressure sensitive labels because they’re more complex. Shrink bands are film strips that are shrunk to fit around the cap and neck of a bottle or jar to show the product hasn’t been opened. You can choose between non-perforated or perforated for easy removing, and blank or custom printed design (recommended for brand identity and anti-counterfeiting).
Tamper evident seals and anti-counterfeiting techniques offer brand owners many benefits like product security, brand identification, and product authentication.
7) ePedigree label: The ePedigree label tracks the origin of prescription drugs through an electronic pedigree and provides data on the history of a particular batch of a drug. When the system is set up, this tracking is done during the reception and the dispatching stages of the batch. On the reception side, Pedigree IDs are automatically generated when purchase order lines, holding batch/date controlled items, are activated for ePedigree tracking.
Thus anti-counterfeit packaging, which is mainly intended to prevent brand reproduction can also enable brand protection and enables clients to distinguish between original and counterfeit.