AI Overview...
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Substandard Injection - Several cases involve injections found to be substandard due to contamination, particulate matter, or deviation from quality standards. For example, a Dextrose Injection was alleged to be defective and substandard, but evidence was inconclusive regarding its role in causing death (01200022936, 01200001541). Similarly, injections like Sodium Chloride and Zobromin were found to contain foreign particles or be of substandard quality, leading to legal actions against manufacturers and sellers (02700002867, 02200009051). In some cases, the presence of particulate matter alone was insufficient to classify the drug as substandard without proper analysis (02700002867).
References: Krishnamoorthy VS Director, Health & Family Welfare Services, Pondicherry - Consumer, Hindustan Antibiotics Ltd. VS The State of Rajasthan - Rajasthan, PREM PHARMACEUTICALS VS STATE OF M. P. - Madhya Pradesh, BICHITRANANDA VS STATE OF ORISSA - Orissa, RAJ ARORA VS RUSOMA LABORATORIES (P) LTD. - Consumer -
Legal and Regulatory Aspects - Under the Drugs and Cosmetics Act, 1940, the presence of substandard drugs can lead to prosecution, criminal liability, and cancellation of licenses. Courts have emphasized the importance of expert evidence and proper testing to establish substandard quality. For example, the mere presence of particulate matter does not automatically deem a drug substandard; detailed analysis is necessary (01700031230). Cases also highlight that lack of knowledge by license holders does not exempt them from liability if substandard drugs are stocked or sold (02200009051).
References: Hindustan Antibiotics Ltd. VS The State of Rajasthan - Rajasthan, BICHITRANANDA VS STATE OF ORISSA - Orissa, PREM PHARMACEUTICALS VS STATE OF M. P. - Madhya Pradesh -
Medical Negligence and Injection Quality - In medical cases, the administration of substandard injections, such as contaminated or infected vials, has been linked to adverse outcomes like infections. However, establishing negligence requires expert evidence and proper medical records. For instance, allegations that a doctor administered a substandard injection leading to infection were not conclusively proved due to lack of substantive evidence (01200022936).
References: Krishnamoorthy VS Director, Health & Family Welfare Services, Pondicherry - Consumer, RAJ ARORA VS RUSOMA LABORATORIES (P) LTD. - Consumer -
Quality Standards and Storage - Proper storage conditions are critical for maintaining injection quality. For example, adrenaline injections must be stored in specified conditions to prevent deterioration, and tests are conducted to verify compliance with pharmacopoeial standards (01200016992).
Reference: Warren Phanllaceuticals Pvt. Ltd. VS Santhosh Kumar - Consumer -
Conclusion - The determination of whether an injection is substandard depends on detailed scientific analysis, proper storage, and expert evidence. Mere suspicion or presence of foreign particles does not suffice; comprehensive testing and adherence to regulatory standards are essential for establishing substandard quality. Legal actions are often based on violations of the Drugs and Cosmetics Act, with courts emphasizing the importance of evidence and procedural correctness in such cases.
Search Results for "Substandard Injection"
• India - Consumer
M.A.EMILE, V.BAKTHAVATSALU
party gave sub-standard injection could not be accepted - Complainant could not be said to have proved a case of deficiency in service ... of doctor- In case of medical negligence evidence of an expert was essential - Medical record did not indicate that sub-standard injection ... Protection Act, 1986 Sections 12 and 17 - Medical negligence - Cataract in eye of complainant was operated in General Hospital - Due to infection ... It is alleged in the complaint that the doctor who performed the first surgery has administered inject....
2008 0 Supreme(Raj) 2680 • India - Rajasthan
RAGHUVENDRA S.RATHORE
of the proceedings dismissed, held – the Petitioners did not raise any objection to order when cognizance of the offence of the substandard ... sample of Injection Dextrose I.P. found and the stage is not proper to move a petition for quashing of proceedings which were dismissed ... The Inspector is said to have noticed some suspended particulate matter in one plastic bottle of Injection Dextrose I.P. (5% WN) (540 MI.). ... Therefore, the drug was also to be treated as substandard. The copy of the Analyst report was sent....
• India - Crimes
AJAY RASTOGI
Act, 1940—Sections 27(b)(i), 27(d), 27(c ) r/w 18 (a)(i), 18(a)(vi), 18(b), 16(i)(a), 17(b), 17A(a) —Sample of “Dexamethasone” injection ... found to be of substandard quality—Order summoning manufacturing firm and its partners—Petition there against—For criminal liability ... to the hospital and after supply to Hospital’s Wards on 26.7.1988, 44 vials of such injection in its stock were found having change in its original colour besides seemingly infected by fungus. ... This letter was endorsed to Drugs Inspector who after inquiry prepare....
1989 0 Supreme(MP) 161 • India - Madhya Pradesh
K.L.SHRIVASTAVA
drug, namely, intravenous fluid Sodium Chloride injection, which was found to contain particles of foreign matter. ... Whether the drug in question was substandard within the meaning of Section 18 of the Drugs and Cosmetics Act, 1940? 2. ... The drug cannot be said to be substandard merely on the ground of the presence of particulate matter, in the absence of analysis ... Labelling : The label on the container of the injection intended for intravenous infusion states (1) that the injection contains 150 ....
1986 0 Supreme(Ori) 200 • India - Orissa
K.P.MOHAPATRA
One of the drugs, Zobromin Injection, was found to be of substandard quality by the Government Analyst. ... DRUGS AND COSMETICS ACT, 1940 - SECTION 27(A)(I) AND (II) - CONVICTION FOR STOCKING AND SELLING SUBSTANDARD DRUGS - LEGALITY OF ... attorney holder of his wife who had a valid license under the Drugs and Cosmetics Act, 1940, was convicted for stocking and selling substandard ... He had no knowledge that any drug was of substandard quality. ... One of the drugs namely, Zobromin was found to be of #....
2019 0 Supreme(Kar) 240 • India - Karnataka
JOHN MICHAEL CUNHA
Drugs and Cosmetics Act, 1940 - Prosecution for selling substandard drugs - Section 34 - Section 470 of Cr.P.C. - Complete analysis ... period for filing complaint Fact of the Case: The petitioners sought to quash the proceedings against them for selling substandard ... Responsibility of individuals in a company, Limitation period for filing complaint Ratio Decidendi: The test report's indication of substandard ... -250 Cefotaxine for Injection IP B.No.GM-134, D/M: 09/2008, D/E: 08/2010. ... CSI Hospital Pharma was of #....
2020 6 Supreme 420 • India - Supreme Court
Appellant is a licensed drug manufacturer – Drugs in question have been found to be misbranded and not spurious or adulterated – Injection ... with Oxytetracycline injection), thus violating clauses 8.12 and 8.23 of the Tender of 2006-07. ... The product was not substandard or spurious veterinary medicine. 4. ... The label 'XYO701' on the injection was an inadvertent human error. The brand name of the medicine was correctly mentioned as "OXY-125". The composition of the medicine was also correctly mentioned as "Oxytetrac....
2022 0 Supreme(Guj) 1326 • India - Gujarat
ARAVIND KUMAR, ASHUTOSH J. SHASTRI
The court found that the rejection of the petitioners' bid was justified based on their debarment for supplying substandard quality ... For example, Amoxycillin Capsules 250 mg is a medicine demanded some 5 crores and more, whereas Atracurium Besilate Injection in large quantity and State machinery is quite clear that no substandard supply to be permitted from any corner and as such, in larger public interest also, it is not desirable ... Item Code 1017 Amoxicillin Capsules IP 250 mg, Item Code 1403 Trimethoprime & Sulphamethoxazole 160 m....
• India - Consumer
S.S.SANDHAWALIA, BASANTI DEVI, S.KULWANT SINGH
Arora allegedly caused by the administration of a Dextrose Injection. ... The complainant, the deceased's widow, claimed that the injection was defective and sub-standard. ... analyzed the allegations of medical negligence and the quality of the Dextrose injection administered to the deceased. ... The batch number of the Dextrose injection is then sought to be put in doubt and it is pointed out that there is no evidence whatsoever that either the death of the deceased was due at all to the Glucose injection#HL_....
• India - Consumer
The name of the drug is mentioned 'as Ugnoz 2%1A Injection. ... It has to be kept in a cool dark place with a temperature between 8-25, learned Counsel invited our attention to ''The Extra Pharmacopoeia, twenty eighth Edition, page 2, where under the heading' Adrenaline injection it is stated as follows:- ... "Injection should be stored in a cold ... We are inclined to hold that as the test was intended to find out whether the drug was of substandard quality all the required tests necessary to find out truth of allegatio....
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