SYNDICATE ACTIVITY

GROUP – D GODAVARI

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Interpretation of Definition of Drug, Manufacture, Spurious, Adulterated, Misbranded Drugs and Section 18C of Drugs and Cosmetics Act

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Participants : T/NIHFW/M/06-24/16 to 20 and

T/NIHFW/M/06-24/36 to 40

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Drug (section 3 (b))

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes;

(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette;

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Drug contd…

(iii) all substances intended for use as components of a drug including empty gelatin capsules;

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

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Manufacture Section 3 (f)

It includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug [or cosmetic] with a view to its [sale or distribution] but does not include the compounding or dispensing [of any drug, or the packing of any drug or cosmetic,] in the ordinary course of retail business; and ―to manufacture shall be construed accordingly]

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Spurious drugs (Section 17(B))

(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

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Spurious drugs contd…..

(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.

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Adulterated drugs (Section 17 (A) )

(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.

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Misbranded drugs (Section 17)

(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

(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.

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*17 (b) – Drugs which does not comply the Labeling requirements given in Drugs & Cosmetics Rules, 1945 (Rule 96 to Rule 104)

*17 (c) - Drugs which does not comply the Rule 106 of Drugs & Cosmetics Rules, 1945.

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Section 18 (C)

Manufacture for sale or for distribution, or sell, or stock or exhibit or offer for sale,] or distribute any drug [or cosmetic], except under, and in accordance with the conditions of, a license issued for such purpose under Chapter IV of Drugs and Cosmetics Act 1940.

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Without license manufacture, sale, distribution, stock of drug or cosmetics

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Investigation & Launching of Prosecution with respect to illegal purchase & sale of Spurious Drugs�(Liposomal Amphotericin B Injection)

• Patient’s relative bought 42 Amphotericin Liposomal Injections at a higher price than the MRP from Accused No. 1.
• Some of these injections were administered to the patient who was suffering from mucormycosis.
• After administering 22 injections, the patient’s condition deteriorated instead of improving and eventually he expired.
• The doctor suspected the quality of the product.
• Patient’s relative lodged a complaint at the local police station.
• Police requested our participation in the investigation.
• We went to the police station and took legal samples.
• The remaining quantity of injections were seized by the police under the Essential Commodities Act for charging higher than the MRP.

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• Joint Investigation Findings:
• One of the accused, a production supervisor in a manufacturing company, had stolen some vials of another product from the company.
• He also stole labels of liposomal Amphotericin injection from the quarantine area of the company.
• He removed the original labels from the stolen vials and affixed them with the stolen Amphotericin labels.
• He then sold these mislabeled vials at a higher price to several accused in this case, eventually reaching Accused No. 1 who sold them to the patient’s relative.
• Sampling Result in Form 13: Nil Content (Declared Spurious)

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Violations

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Original Product Vial: Yellow Color Lyophilized Cake

Spurious Product Vial: White Color Lyophilized Cake

TEAM – GODAVARI GROUP IV�1) Mr.Gaurang Shirgaonkar 6)Mr.Gourav Kumar Singh�2) Mr.Mahek Shah 7)Mr.Chandan Kashyap�3) Mr.Saumin Patel 8)Mr.Prakash Koli�4) Mr.Dinesh Rana 9)Mr.Premdas Sakhare�5)Smt.Neelima Ashok Kottan 10)Mr.Manish Suman

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