Current scenario of spurious and substandard medicines in india: A systematic review

Abstract

Globally, every country is the victim of substandard or spurious drugs, which result in life threatening issues, financial loss of consumer and manufacturer and loss in trust on health system. The aim of this enumerative review was to probe the extent on poor quality drugs with their consequences on public health and the preventive measures taken by the Indian pharmaceutical regulatory system. Government and non-government studies, literature and news were gathered from journals and authentic websites. All data from 2000 to 2013 were compiled and interpreted to reveal the real story of poor quality drugs in India. For minimizing spurious/falsely-labelled/falsified/counterfeit drugs or not of standard quality drugs, there is urgent requirement of more stringent regulation and legal action against the problem. However, India has taken some preventive steps in the country to fight against the poor quality drugs for protecting and promoting the public health.

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“…Counterfeit and fraudulent medication is a growing problem, especially in parts of the world where regulation and cooperation between governments is lacking (McLaughlin, 2012). Detailed and trustworthy pharmaceutical provenance and chain-of-custody information could be built into a blockchain solution, such that local distributors and consumers could audit their own supply and combat fraudulent practices such as relabelling of expiration dates and counterfeiting (Buckley & Gostin, 2013;Khan & Khar, 2015;McLaughlin, 2012;Sprink et al, 2016). Pharmaceuticals are part of a much more general case: everything we consume affects our health, and recently major retailers and food companies have announced a collaboration to identify major areas in the global food supply chain that could benefit from tracking through blockchain technology (Aitken, 2017).…”

Spurious drugs: do we neglect during our clinical practice? a systematic review

“…When treatment fails, the prescriber should consider that spurious medicines would be the cause. 14,15 The physician should follow the provisions of state act like Drugs and Cosmetic act 1940, Pharmacy Act 1948 and other acts for optimum protection and promotion of public health. For those doctors who purchase and dispense medications, they do have the responsibility to avoid any infiltration of spurious medicines with a legitimate food chain.…”

Counterfeit drugs in India: significance and impact on pharmacovigilance

“…High levels of impurities and contaminants (8.5%). 4 India does not have an official definition for counterfeit drugs. Section 17-B of Drugs and Cosmetics Act, 1940 has defined spurious drugs (subsequently amended in 1980) as "A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer."…”

“…Section 17-B of Drugs and Cosmetics Act, 1940 has defined spurious drugs (subsequently amended in 1980) as "A drug shall be deemed to be spurious if it is manufactured under a name which belongs to another drug, if it is an imitation of another drug or if it has been substituted wholly or partly by another drug or if it wrongly claims to be the product of another manufacturer." 4 Spurious drugs have been divided into the following categories: 3. Category C (Minor defects): Legally licensed companies manufacture such drugs which may have minor defects that do not cause any significant harm.…”