COUNTERFEIT DRUGS - INSTRUMENTS OF CHANGE AND VARIOUS REGULATIONS IN PLACE

Medicines that are brought into the market to be sold with a devious intention regarding their origins and efficacy are called counterfeit drugs. Such drugs are fake and they can be mislabeled purposely which is known as fraud [1], [2].

DATA CONCERNING FAKE DRUGS IN THE MARKET:

1. The actual percentage of fake drugs in the Indian market is 0.3%, as opposed to 10 to 25% reported in the media.

2. The annual transactions of fake drugs is more than 6,500 crores.

3. The percentage of fake drugs sold in Peru is 80%.....a bit contradictory! The same patients are still alive [3], [4].

4. Websites that sell drugs to patients by not mentioning their address accurately, contribute about 50% in the menace of drug counterfeiting [5].

5.
Year | Number of drug samples tested by CDSCO | Number of drug samples found to be fake

2007-2008 | 39,117 | 2,429
2008-2009 | 45,145 | 2,597
2009-2010 | 39,248 | 1,942
2010-2011 | 49,682 | 2,372
2011-2012 | 48,082 | 2,186 [6]


INSTRUMENTS OF CHANGE:

1. Pharmacists - Drugs have to be brought from sources that have some set standards and can be relied upon. In the US, a drug cannot be sold without a prescription across the internet due to the Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Even then this menace of buying and selling counterfeit drugs continues through unapproved websites. Various organizations have contributed their bit to stem this menace; but the most important initiative was taken by The National Association of Boards of Pharmacy (NABP). A database of online pharmacies was generated that are genuine and have proper licenses to operate across the internet.


Various steps can be put in place to check incoming counterfeit drugs:

a) Short supply of drugs can be looked after by making use of alternative drugs and measures to prevent stockpiling. Approval should be granted to new suppliers only after checking their backgrounds, also going through their licensing status as wholesalers, finding out whether any existing cases are present against the organisation etc.

b) It is the duty of the pharmacists to obtain circulars regarding counterfeit drugs from at least one of these associations:
• The American College of Clinical Pharmacy
• National Association of Chain Drug Stores
• National Community Pharmacists Association


The pharmacists have to also ensure that the products bought and sold by them are authentic.

a) The technology for detecting fraud in packaging and dosage forms has to be easy to learn, make use of, cost-effective and secure. Drugs should also be checked for their dubious appearances. Packaged drugs can be protected by holograms, embedded codes, images etc. Computerised systems along with softwares that give a detailed account of the drug's appearance on the receipt provided by the pharmacist bring down the levels of drug counterfeiting.

b) Drug manufacturers can also incorporate physical-chemical identifiers (PCIDs) inside solid oral dosage forms. They are inks, chemical tags etc and can be found out using infrared, ultraviolet technology or even by using magnifying glass.

Theoretical knowledge to educate oneself about counterfeit drugs can be obtained from Partnership for Safe Medicines. The practical aspects of preventing drug counterfeiting can be obtained from World Health Organisation, Royal Society of Great Britain and the International Pharmaceutical Federation.

Medwatch acts as the watchdog for counterfeit drugs. Investigators go to pharmaceutical companies to conduct surprise checks and verification tests, if asked for [7].

2. Doctors - Doctors are in touch with their patients when they are affected spiritually and mentally, with some disease however big or small it may be.

a) Patients should be discouraged from taking drugs on their own without their doctor's advice; this practice may encourage manufacturers and distributors of drugs, to counterfeit drugs.

b) Maintaining good relations with pharmacists so that they give their help and advice in drug dispensation and management. They can also be held accountable for committing mistakes (big or small), if they are present in place of inexperienced persons.

c) Encourage patients to procure drugs from established sources only, when they buy medicines from outside the hospital premises.

d) Stress has to be laid on pharmacists so that they check the packaging of the drug for date of expiry, mistakes in spelling out the drug name etc- well in advance, before purchasing medicines from distributors.

e) Each and every Adverse Drug Reaction has to be made known to the concerned authorities including the absence of the desired effect to be observed upon administering a drug. This would in turn assist in finding out drugs of inferior quality i.e. fake drugs.

f) Letting patients know their schedule of drug consumption and instructing them to mention each and every ADR to their doctor.

g) Spreading knowledge about genuinity of drugs by going through medical journals, magazines etc [8].


REGULATIONS & PROGRAMMES IN PLACE TO COMBAT COUNTERFEITING OF DRUGS:

1. India - The Drugs and Cosmetics (Amendment) Act, 2008 was implemented in August 2009- to raise the amount of fine paid by the manufacturers on generating fake or counterfeit drugs. The punishment ranges from 10 years in jail to life imprisonment along with a fine of `10 lakhs or triple the value, of the amount of fake drugs held. A framework for whistle blowers is also on the anvil which will encourage persons to give data on the manufacture and supply of fake drugs [9].

Two senior retired policemen have collaborated with the Indian Pharmaceutical Alliance (IPA) to solve the problem of counterfeit drugs. Also, the Organization of Pharmaceutical Producers of India (OPPI) is assisting the International Federation of Pharmaceutical Manufacturers Association plus the Pharmaceutical Security Institute- to lay down a roadmap by which the phenomena of drug counterfeiting can be reined in [10].

2. USA - A website has been generated for consumers by the FDA and the National Consumers League of the US, to spread data about fake drugs. Using the Med Watch program as a tool, persons working in the healthcare sector can relay the data of fake drugs to the FDA. The hotline of the FDA would then immediately give its interpretation of the suspected wrongdoings [10].

The bill, H.R. 1919, was given the go-ahead, by the U.S. House that would make the setting up of national standards for overseeing the prescription drug distribution, a compulsory requirement. There are restrictions applied on drug suppliers so that they trade with established organizations only [11].

3. UK - The steps in the EU Falsified Medicines Directive became active from January 2013. Stress was laid upon three sections: preventing drug counterfeiting, steps to handle the wrongdoing and the mechanism for finding the guilty. Drug counterfeiting would be prevented by market surveillance, vigilance at UK ports and Pharmacovigilance. Handling the wrong doing would be done by calling back the entire batch of fake drugs and reducing the amount of knowledge that goes out to the public. Finding the guilty party would be through consistent follow-up and prosecution along with the involvement of the money trail [12].

REFERENCES:

1. http://en.wikipedia.org/wiki/Counterfeit_medications

2. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/CounterfeitMedicine/

3. http://www.safemedicinesindia.in/others5.php

4. Central Drugs Standard Control Organisation (Government of India). Report on countrywide survey for spurious drugs. 2009. Website:
http://cdsco.nic.in/report_book_13-7-10.pdf

5. http://www.allcountries.org/health/counterfeit_medicines.html

6. http://www.rediff.com/money/report/surge-in-cases-of-fake-drugs-whistleblower-plan-draws-a-blank/20130211.htm

7. Chambliss W G, Caroll W A. Role of the pharmacist in preventing distribution of counterfeit medications. J Am Pharm Assoc. 2012; 52[2]: 195-199.

8. Dr Akunyili D. Fake and Counterfeit drugs in the health sector: The role of medical doctors. Annals of Ibadan Postgraduate Medicine. 2004; 2[2]: 19-23.

9. http://www.livemint.com/Home-Page/q0T5vAAckF3YlKVLPjZd8N/Stricter-law-on-fake-drugs-now-in-force.html

10. Gautam C S, Utreja A, et al. Spurious and counterfeit drugs: a growing industry in the developing world. Postgrad Med J. 2009; 85: 251-256.

11. http://www.bloomberg.com/news/2013-06-03/u-s-house-passes-bill-to-find-track-counterfeit-drugs.html

12. http://www.securingindustry.com/pharmaceuticals/uk-regulator-launches-new-counterfeit-medicine-strategy/s40/a1234/


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