The dictionary meaning of counterfeit is 'made to look exactly like something in order to trick people into thinking that they are getting the real thing'. The counterfeiting is the problem for branded products like FMCG, medicines etc. But when the matter of counterfeit medicines is there, one must be very serious as it is directly connected with the health of the public. The counterfeit drugs may be adulterated, spurious or the misbranded drugs. As per the D&C Act 1940 and its amendments the terminologies are defined as follows: Adulterated drugs are defined as the 'drugs consisting of filthy, putrid or decomposed substances, or colours other than those prescribed or drugs processed and stored under conditions which are likely to make them injurious to health or drugs packed in containers composed of poisonous or deleterious substances or drug which contain any harmful or toxic substances which make them injurious to health or drugs which have been mixed up with any substance likely to reduce their quality or strength'.
Misbranded drugs are defined as 'drugs, coloured, coated powdered or polished so as to conceal (hide) damage or to appear of better therapeutic value than they really are, or drugs false and misleading in claims or drugs not labelled in the prescribed manner or imported under name of other drug'.
Spurious drugs are defined as 'drugs imported under the name which belong to another drug or drugs which are manufactured under a name which belongs to another drug or drugs which are imitations or substitutes for other drugs or resemble other drugs in a manner likely to cause cheating or bear names of manufacturers which are made up fictitious (not genuine) and of whom they are truly not the products or drugs which have been partly or wholly substituted by other substances or drugs'.
The counterfeiting of medicines is the basic problem faced by the major pharmaceutical brands. The situation is so serious that combating this problem has become a herculean task for the pharma manufacturers. The counterfeits of the originals are so intelligently prepared that it becomes very difficult to differentiate them. Major brand manufacturers are not only losing their profits but also the identity and consumers’ loyalty to the brand. This is a serious issue which adversely affects the company’s market share in long run. Something must be done to either product or packaging to differentiate the original brands from the counterfeit. There are several ways by which it is possible to combat the counterfeiting, which are proposed to be implemented by the government of India.
Ways to combat counterfeit drugs
Counterfeit drugs is not a new problem, it is in existence from the introduction of the brands. Initially the brands were protected by the copy righted trade name and the trademarked logo. But the counterfeiters are smart enough to copy all the content of the label as the technology advanced. Shining logos are introduced in the nineties to fight against the counterfeits which are still popular. The 1D barcodes with the appearance of group of several vertical straight lines of different thickness are used to protect the genuinity of brands with the stored information. As in software industry anti virus programme is always prepared along with the virus programme, for all these conventional methods the loopholes are there by which the counterfeiters play their game.
Smart ways to combat counterfeit drugs are 2D barcodes, Unique Identification (UID) codes and RFID tags.
2D barcodes
A 2D barcode or data matrix code contains more information than a conventional 1D barcode. 2D barcodes consist of black and white square modules arranged in a square or rectangular pattern. These barcodes contain multiple levels of information such as lot numbers, date of manufacture, expiration date, manufacturer location and distribution channel, component details, and unique serial numbers. 2D barcodes are easily added to cartons and labels that already exist since the amount of space needed is relatively small.
Significant quantities of encrypted information can be stored this way to support pharmacists, regulatory agencies and government authorities in the authentication and tracing of individual drug brands. 2D data matrix bar codes make counterfeit medicines easily identifiable. Scanners in pharmacies can read the bar codes for the authentication. Scanned information is transmitted to an independent electronic data hub and a verification message is quickly returned to the dispensing pharmacist.
UID codes
It is also called as unique randomly generated numeric code. The unique identification is a global asset tracking system for hard products. The UID tracking ensures asset location and operational quality data integrity of the product. The UID is a particular software generated alpha-numeric random code which is given to each unit of product. This software is designed in such a way that it will never produce the same numbers as it has been generated by various permutations and combinations. At the time of purchase, the customer needs to send an SMS with that unique identification to a particular code at nominal SMS tariff to ensure the genuinity of the product. The customer gets informatory response from the company’s side to ensure authenticity and with awareness or instructions of usage of the product. The total process takes five to ten seconds. The number of attempts to validate a particular product can be pre-controlled as well as regulated to ensure no reuse of the code by the duplicators. If it sends a normal default response for the first attempt, for the second attempt, it will send a different response informing its earlier validation. The default responses are of course as set by the product manufacturers and can be updated or changed from time to time. A fully automated process eliminates all chances of errors.
Features and benefits of UID
There are few other major benefits of unique identification (UID). The UID provides a regular and very useful database to the manufacturer with mobile number, location, frequency of purchase and mobile numbers with location, attempting validation with wrong code. This will again help the manufacturer locate the most effected locations of the market by the duplicates, so one can take required necessary steps particularly there.
With all the above mentioned features and benefits, the UID becomes a full proof tool to fight the counterfeits in the market and eliminate them from the root. The manufacturers must use it to retain its satisfied customers in the long run.
RFID tags
The Radio Frequency Identification (RFID) is a semiconductor in a label or tag that stores information. Data is read or written to the tag when it is exposed to radio waves of the correct frequency. The RFID technology uses RFID tags affixed on cases and consignments and a serialised electronic product code for identification, detection and subsequent segregation of genuine and counterfeit drugs.
Indian drug industry and UID
It is a good news and really a new wave of wind that, Drug Consultative Committee of India has proposed and recommended to mandate 2D barcodes and unique identification on the labelling of the drugs. The recommendation has been sent to Drug Technical Advisory Board (DTAB) and final notification is yet to come from the Union health ministry.
As per the recommendations, Government will have to amend Rule 96 (manner of labelling requirement) of the D&C Act, saying "every drugs manufactured in India shall bear on its primary label unique identifier code and 2D barcodes that shall be used for anyone to verify the drug through a system of SMS by mobile phone." As the amendment in Act is very tedious to implement in the Indian government system, but it is the need of present time and must implemented as soon as possible in lieu of the public benefit.
If implemented, India will join Italy, Malaysia and the EU to make 2D barcodes and UID mandatory in an effort to combat spurious and counterfeit drugs.
It is matter of pride that some Indian drug makers have already taken the plunge independently of any government mandate. Last year for example, Unichem Laboratories implemented barcodes in order to protect its anti-anxiety drug Trika (alprazolam) and Losar (losartan) for high blood pressure from counterfeiting and diversion.
The move is expected to meet opposition, however, from small and medium-sized pharmaceutical manufacturers, which are concerned about the extra cost involved in adding barcodes and UIDs to product labelling. However, sufficient time must be given to manufacturers to implement the changes.
Conclusion
The counterfeit and spurious drug is the basic problem that Indian drug industry faces. By present labelling requirements and tools to protect counterfeiting, it is very difficult for the regulatory agencies to differentiate brands and their counterfeits. Therefore, it is right decision and appropriate time to implement smart systems like unique identification and 2D barcodes system for the Indian drug industry. Although, initially the cost of the medicines will slightly raise but the medicines will ensure the safety and efficacy by combating with the counterfeit and spurious drug. The cost per pack would fall dramatically once the technology is widely adopted.
(The author is with Veerayatan Institute of Pharmacy, Bhuj-Mandvi Road, Jakhaniya, Tal- Mandvi- Kutch, Gujarat 370 460).