Counterfeit drugs in India: significance and impact on pharmacovigilance

Shah, Nehal A.; Sattigeri, Bhagya; Patel, Nirav; Desai, Haresh A

doi:10.18203/2320-6012.ijrms20150596

Cited by 10 publications

(4 citation statements)

References 5 publications

(8 reference statements)

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“…This finding also corroborates with previous studies reporting that India is among the biggest suppliers of drugs circulating in Africa. 29 Regarding the drug products, CFX represented 38% of the collected samples, followed by CFD (23%), AZT (21%), and ERH (18%). Indeed, 11 different manufacturers of CFX were identified in the region, versus eight for AZT, seven for CFD, and six for ERH.…”

Section: Resultsmentioning

confidence: 98%

Detection of Substandard and Falsified Antibiotics Sold in the Democratic Republic of the Congo Using Validated HPLC and UV-Visible Spectrophotometric Methods

Tshilumba,

Ilangala,

Mbinze Kindenge

et al. 2023

The American Journal of Tropical Medicine and Hygiene

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The access to afford safe, effective, and genuine medications is a major challenge for people in low- to middle-income countries. This study aimed at developing and validating simple, accurate, and inexpensive analytical liquid chromatography and ultraviolet-visible spectrophotometric methods to ensure quality control of antibiotics sold in formal and informal pharmaceutical markets. It focused on four antibiotics (azithromycin [AZT], cefadroxil [CFD], cefixime [CFX], and erythromycin [ERH]) used to treat infectious diseases in the region of Haut-Katanga in the Democratic Republic of the Congo (DRC). The total error strategy (accuracy profile) matching with the validation requirements of International Council on Harmonization was used for the validation. The validation results showed that three analytical methods of AZT, CFD, and ERH were validated according to the accuracy profile obtained, whereas the proposed method of CFX was not validated. Therefore, the United State Pharmacopoeia method permitted to quantify CFX samples. The dosage intervals ranged from 25 to 75 µg/mL for CFD, from 750 to 1,500 µg/mL for AZT, and from 500 to 750 µg/mL for ERH. The application of the validated method to samples collected (N = 95) allowed the detection of 25% substandard antibiotics with a rate of poor quality much higher in the informal circuit compared with the formal one (54% versus 11%; P < 0.05). The routine application of these methods will strengthen the quality control of drugs marketed in DRC. This study gives evidence for the availability of poor-quality antibiotics in the country, requiring the immediate attention of the national medicine regulatory authority.

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Section: Resultsmentioning

confidence: 98%

Detection of Substandard and Falsified Antibiotics Sold in the Democratic Republic of the Congo Using Validated HPLC and UV-Visible Spectrophotometric Methods

Tshilumba,

Ilangala,

Mbinze Kindenge

et al. 2023

The American Journal of Tropical Medicine and Hygiene

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“…5 The global market for counterfeit drugs is estimated to be at US $200 billion in which India repercussions worth of 15 billion dollars. 6 There are several reasons for counterfeit medication, the most common are lack of pharmacies or health clinics in rural area, cost effective (relative cheaper), poor legislative and regulatory framework for monitoring drug quality and imminent awareness of society towards its adverse effect. 7,8 The present questionnaire study was based on knowledge and attitude towards counterfeit medication among the medical practitioner in tertiary care hospital.…”

Section: Discussionmentioning

confidence: 99%

A questionnaire-based study on knowledge and attitude towards counterfeit medication among the doctors in tertiary care hospital

Yadav¹,

Budania

Mondal

et al. 2018

Int J Basic Clin Pharmacol

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Background: Counterfeit drugs are a global problem and suffered almost all developing and developed countries worldwide. In India, it is a major problem which results life threatening issues as well as financial loss on health system. So, we conducted a cross sectional questionnaire-based study on knowledge and exposure to counterfeit drugs of doctors at SHKM Govt. Medical College, Nuh, Haryana, India.Methods: A structured questionnaire was distributed to 100 registered doctors. The questionnaire was based on knowledge, attitude and its consequence on the heath system by the practices of counterfeit medication.Results: There were Twenty questionnaires excluded from the study due to incomplete information. Only 57.77% (46/80) subjects having the knowledge of questionnaire correct meaning of counterfeit drug. However, almost 90% (72/80) subjects were aware about its dangerous effects. More than 50% of the subjects have suggested that modern technology is capable to control counterfeiting of the medicine.Conclusions: Counterfeit drugs create a people health hazard and waste to consumer income. The proper knowledge, awareness and modern technological approaches are the devices may helpful in diminution of counterfeit medication practices.

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“…Several factors are chargeable for this, including the extent of corruption in a very country and its poverty rate. E) Request surpassing stock: Disappointment of a nation's production network to satisfy the requirement for meds, as within the occurrence of plagues, urges e-ISSN: 2321-6794 [11] forgers to flood the market with misleading medications Exorbitant costs. ( 9)…”

Section: D) Lack Of Enforcement Of Existing Regulationsmentioning

confidence: 99%

A Comprehensive Study on Counterfeit Medicine and its prevention in India through its Regulatory Approach

Singh¹,

Gupta²

2022

Int J Drug Reg Affairs

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A counterfeit medication is one which is intentionally and false mislabeled with relevance identity or source. Counterfeiting applies to both brand and generic products which incorporate items with wrongs ingredients, without active ingredients, with inadequate active ingredients. Worldwide, each nation is that the survivor of substandard or spurious drugs, which end in life threatening issues, loss of consumer and manufacturer and loss in trust on health system. Internationally, the trade in counterfeit drug is of the quickest developing grey economies – after narcotics, terrorism, and arm trade. In term of revenues, India Is world’s leading in generic companies. India has the notoriety of being a significant producer of the world's counterfeit drugs. Counterfeit drugs structure 10% of the counterfeit drugs in line with the world Health Organization (WHO). As Per BASCAP-"Drug industry is that the premier falsified industry in India". The point of this enumerative review was to clarify the effect of poor-quality drugs with their outcomes on public health and also the preventive measures taken by the Indian drug administrative framework by CDSCO. India should adopt the technologies present in other countries to combat counterfeit medicine.

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Counterfeit drugs in India: significance and impact on pharmacovigilance

Cited by 10 publications

References 5 publications

Detection of Substandard and Falsified Antibiotics Sold in the Democratic Republic of the Congo Using Validated HPLC and UV-Visible Spectrophotometric Methods

Detection of Substandard and Falsified Antibiotics Sold in the Democratic Republic of the Congo Using Validated HPLC and UV-Visible Spectrophotometric Methods

A questionnaire-based study on knowledge and attitude towards counterfeit medication among the doctors in tertiary care hospital

A Comprehensive Study on Counterfeit Medicine and its prevention in India through its Regulatory Approach

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