Counterfeit or Fake drugs : With the advent of Online pharmacies, the phenomenon of  Fake drugs has gathered momentum not only in India but throughout the world.

Here are a few recent news headlines on Fake drugs:

  • One Out Of 10 Medicines May Be Fake In India, Causing Severe Illnesses States WHO
  • Fake drugs in India may cross US $10 billion in next three years: ASSOCHAM
  • Fake drugs constitute 25% of domestic medicines market in India
  • Majority of the drugs found in India are either fake or ineffective.
  • According to the World Health Organisation (WHO), 35 percent of the fake drugs sold all over the world comes from India and it occupies the counterfeit drug market of nearly Rs 4,000 crore. 20 percent of the drugs sold in India are fake. Drugs prescribed for cold and cough or a headache are mostly either fake or of poor quality.
  • Your medicine box may have fake drugs

 A growing menace everywhere in the world, governments of different countries are always busy fighting the issue of spurious drugs. 

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The ways to control may be different from country-to-country but reporting data from users is the key. Until it is reported, it is really tough to catch the culprits.Usually the pharmaceutical regulatory authorities and pharma companies have online reporting portals available on their sites.

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One of the reasons in increasing incidence of Fake drugs is advent of online pharmacies. It increases the ease of ordering the medication & access, but in a uncontrolled environment it may boost the business of Fake drugs. Online Pharmacy distribution is increasing gradually & precaution is to be taken while buying from these pharmacies.

A few ways to find the credibility of online pharmacies are:

  • If they allow you to buy prescription medicine without a valid prescription
  • Do not have a licensed pharmacist
  • Offer very low prices/higher discounts that seem too good to be true.
  • Send spam or unsolicited email offering cheap medicine.

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These pharmacies often sell medicines that can be dangerous because they may:

  • Have too much or too little of the active ingredient you need to treat your disease or condition.
  • Not contain the right active ingredient.
  • Contain the wrong or other harmful ingredients.
  • All the medicines need stronger temperature controls & proper storage. As the pharmacy may be storing it in an improper way, the medication may suffer loss of efficacy.

Regulatory system in India for Pharmaceutical sector

Legal basis

The Indian drug regulatory system originated in 1940, when the Drugs & Cosmetics Act was passed to address the sudden and rapid expansion of pharmaceutical production in the country. The Drugs Rules were framed in 1945 to give effect to the provisions of the Act.(4) Both the Act and Rules were subsequently amended many times, and various legislative texts were passed to regulate the import, manufacture, distribution and sale of drugs in India, including:

  • The Pharmacy Act 1948;
  • The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954; The Narcotic Drugs and Psychotropic Substances Act 1985;
  • The Medicinal and Toilet Preparations (Excise Duties) Act 1956;
  • The Drugs (Prices Control) Order (DPCO) 1995 (under the Essential Commodities Act), amended in 2013 to cover specified dosages and strengths under the National List of Essential Medicines (NLEM) 2011 and modified to include medicines in NLEM-2015;
  • The National Pharmaceutical Pricing Policy, 2012 (NPPP-2012) The Patent Act Amendment 2015 (includes amendments in the Patent Act 2002); and
  • The National Health Policy 2017.

Today, most of the Indian health products are governed by the Drugs & Cosmetics Act, which covers a wide variety of drugs, therapeutic substances, diagnostics and medical devices. The regulatory mechanisms and are in line with relevant technical guidelines from international organizations such as WHO, the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and others.

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, Drugs and Cosmetics Act, 1940 and Rules, 1945  As amended up to the 31st December, 2016.

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CHAPTER IV, MANUFACTURE, SALE AND DISTRIBUTION OF, [DRUGS AND COSMETICS]

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 be 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.

17A. Adulterated drugs-For the purposes of this Chapter, a drug shall be deemed to be adulterated,

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been

contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which

may render the contents injurious to health; or

(d) if it bears or contains, for the purposes of colouring only, a colour other than one which is

prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

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.

17C. Misbranded cosmetics– For the purposes of this Chapter, a cosmetic shall be deemed to be

misbranded,

(a) if it contains a colour which is not prescribed; or

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

(c) if the label or container or anything accompanying the cosmetic bears any statement which is

false or misleading in any particular.

17D. Spurious cosmetics-For the purposes of this Chapter, a cosmetic shall be deemed to be spurious,

(a) if it is manufactured under a name which belongs to another cosmetic; or

(b) if it is an imitation of, or a substitute for, another cosmetic or resembles another cosmetic in

a manner likely to deceive or bears upon it or upon its label or container the name of another cosmetic unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other cosmetic; or

(c) if the label or container bears the name of an individual or a company purporting to be the

manufacturer of the cosmetic which individual or company is fictitious or does not exist; or

(d) if it purports to be the product of a manufacturer of whom it is not truly a product.

17E Adulterated cosmetics-For the purposes of this Chapter, a cosmetic shall be deemed to be

adulterated,

(a) if it consists in whole or in part, of any filthy, putrid or decomposed substance; or

(b) if it has been prepared, packed or stored under insanitary conditions whereby it may have been

contaminated with filth or whereby it may have been rendered injurious to health; or

(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or

(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or

(e) if it contains any harmful or toxic substance which may render it injurious to health; or

(f) if any substance has been mixed therewith so as to reduce its quality or strength.

Section 27. Penalty for manufacture, sale, etc., of drugs (CDSCO, India)

Applicable to – Whoever, himself or by any other person on his behalf, manufactures for sale or for distribution, or sells, or stocks or exhibits or offers for sale or distributes:

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Clause a) Any drug deemed to be adulterated under section 17A or spurious under section 1 [17B and which] when used by any person for or in the diagnosis, treatment, mitigation, or prevention of any disease or disorder is likely to cause his death or is likely to cause such harm on his body as would amount to grievous hurt within the meaning of section 320 of the Indian Penal Code (45 of 1860), solely on account of such drug being adulterated or spurious or not of standard quality, as the case may be, shall be [punishable with imprisonment for a term which shall not be less than 10 years but which may extend to a term of life and with fine which shall not be less than 10 lakh rupees or three times value of the drugs confiscated, whichever is more.]

What can be the ways to curb the menace of Fake or Spurious drugs???

  1. Online reporting mechanism at Govt. sites & Pharmaceutical company websites
  2. Strict implementation of rules & regulations with quick judgement
  3. India’s Government Is Working to Track Counterfeit Drugs With Blockchain – The technology hopes to crack down on the sale of fake drugs. Whenever medicine is sold, it will get audited on the blockchain.
  4. Make people aware of the fake medications & how to report it. For Example – National programmes can be launched for education purpose.
  5. Online & offline survey by Govt. authorities.
  6. Awarding those who are whistle-blowers or those who report about fake drugs.
  7. Licensing need to be kept stringent.
  8. Online pharmacies should get covered under special rules & regulations.
  9. More Drug inspectors to be brought in into the system.
  10. Central mobile number to check the batch number validity of the drug.
  11. Central repository of all the licensed pharma entities which can be accessed by general public to check the validity of manufacturer as well as distributor.

References:

https://yourstory.com/2017/06/india-fake-drugs/

https://www.indiatimes.com/health/buzz/one-out-of-10-medicines-may-be-fake-in-india-causing-severe-illnesses-states-who-334657.html

https://timesofindia.indiatimes.com/city/delhi/your-medicine-box-may-have-fake-drugs/articleshow/63349428.cms

https://www.indiainfoline.com/article/news/assocham-5971406133_1.html

http://www.downtoearth.org.in/news/fake-drugs-constitute-25-of-domestic-medicines-market-in-india-assocham-45393

https://www.gov.uk/report-problem-medicine-medical-device

https://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/counterfeitmedicine/default.htm

http://www.cdsco.nic.in/forms/contentpage1.aspx?lid=1888

http://www.complex.com/life/2018/04/india-government-working-to-track-counterfeit-drugs-with-blockchain

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