ATTN:JAYESH PANDIT Extent of Spurious Medicines in India

[Guest guest]

Dear Jayesh:

Thanks for your interesting and very informative attachments. I totally agree with you that this is a topic which is fraught with very serious ramifications on the health and well-being of humanity worldwide as well as on our national and regional economies. This topic deserves as much deliberation as possible. We need to ponder on the factors responsible for proliferating this menace in our country and need to come out with suggestions to curb this evil with utmost urgency. Please comment on the factors contributing towards proliferation of this trade worldwide and in India.

With regards

Dr. Geer M. Ishaq

Sr. Lecturer

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

E-mail: ishaq@...

Website: http://ishaqgeer.googlepages.com

[!! SPAM] Re: Extent of Spurious Medicines in India

Dear Dr.Geer,

This is really a nice topic to discuss.

Due to busy schedule, I am not able to keep in touch.

Congratulations for editing and publishing a wonderful news-letter for NetRUM.

Spurious/fake/ counterfeit drugs can cause many problems in patient care system.They are not efficious.Clinician s are then tempted to either increase the dose or change the medicine.Patients are at risk of developing adverse drug reactions.They have to spend more on medicines.

It will be interesting to discuss how at various levels such drugs are generated and reach the market.

Please don't be disheartened. Your enthusiasm will make this discussion a successful one.

DR. BHARAT GAJJAR

ASSOCIATE PROFESSOR,

DEPARTMENT OF PHARMACOLOGY,

PRAMUKHSWAMI MEDICAL COLLEGE,

KARAMSAD-388325.

DIST.-ANAND (GUJARAT) INDIA.

MOBILE- 09428153344.>> Dear Members:> Contrary to my expectations nobody has so far responded to my request for definitions of medcines that are not of standard quality and efficacy. Consequently I present the same for your kind information here. I can only hope that in the coming days this discussion will not be a one-way traffic any more. The term,

‘Counterfeit’ that is commonly used worldwide for spurious drug does not appear in Drugs and Cosmetic Act but the below given definition of spurious drug comprehensively covers counterfeit drug also. The Drugs and Cosmetics Act also defines “Misbranded Drugâ€, under Section 17 and “Adulterated Drugâ€, under Section 17A. A drug is considered “Not of standard Quality†or substandard if it fails to comply with any of the parameters of the overall standards laid down for it either in a recognized Pharmacopoeia or otherwise pre declared by the manufacturer. According to WHO, a counterfeit medicine is one which, is deliberately and> fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without

active ingredients, with insufficient active ingredient or with fake packaging. The Food and Drug Administration, USA defines counterfeit drug as : “A drug which, or the container of which, or labelling of which, without authorization, bears the trademark, trade name, other identifying mark, imprint or device or any likeness, there of a drug manufacturer, processor, packer, or distributor other than the person, or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by such other drug manufacturer, processor, packer, or distributor.†A counterfeit medicine is one that has no> active ingredient or is an expired drug which has been re-labelled and sold. It’s slightly different from a fake drug, which may not resemble the original in any way.

Counterfeit medicines range from random mixtures of harmful toxic substances to inactive, useless preparations. Occasionally, there can be “high quality†fakes that do contain the declared active ingredient. In all cases, contents of counterfeits are unreliable because their source is unknown or vague and always illegal. Fake drugs can cause harm to patients and sometimes lead to death.The definition of spurious drug included in the Drugs and Cosmetics Act by the Amendment Act of 1982 is given as under:> (a) If it is imported under a name which belongs to another drug ; or > ( 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 contained 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> © 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 only truly a product.Section 17B. Spurious drugs. ��"A drug shall be deemed to be spurious, - > Section 17A. Adulterated drugs. ��"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> ( 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 > © If its contained 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 17. Misbranded drugs.. ��" 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 better or greater therapeutic value than it really is ; or> ( If it is not labelled in the prescribed manner ; or> © If its label or contained or

anything accompanying the drug bears any statement, design or device which is false or misleading in any particular.Section 16. Standards of Quality> According to Section 16 of Drugs and Cosmetic Act 1940, “Standard Quality†means that the drug complies with the standards set out in the Second Schedule. The Second Schedule stipulates that all drugs imported or manufactured in the country have to comply with the standards laid down in the India Pharmacopoeia. The drugs that are not included in the Indian Pharmacopoeia should comply with the standards specified in the official Pharmacopoeia of any other country. The patent or propriety medicines have to comply with the formula displayed on the label or otherwise pre-declared by the manufacturer. A drug is considered not of standard quality, (NOSQ) or sub-standard, if it fails to comply with any of the parameters of the over all standards laid

down for it either in a recognized Pharmacopoeia or otherwise stipulated by the manufacturer. WITH REGARDS> DOES ANYBODY WANT TO ADD SOMETHING TO THESE DEFINITIONS? > Dr. Geer M. Ishaq> Sr. Lecturer> Dept. of Pharmaceutical Sciences> University of Kashmir> Srinagar-190006 (J & K)> Ph: 9419970971, 9906673100> E-mail: ishaq@ ...> Website: http://ishaqgeer. googlepages. com > > > Explore your hobbies and interests. Go to http://in.promos. / groups/>

Meet people who discuss and share your passions. Join them now.

Bollywood, fun, friendship, sports and more. You name it, we have it.