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  1. Home
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  3. 2021 - Volume 7 [Issue 3]
  4. Case Study

NOT OF STANDARD QUALITY DRUGS IN INDIA: A CASE STUDY

  •  AMARESH TUMBAGI
  •  BALAMURALIDHARA V.
  •  S. NARMADA
  •  ASHUTOSH MISHRA

Journal of Case Reports in Medical Science, Page 11-16

Published: 25 December 2021

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Abstract


Drugs manufactured by licenced manufacturers have been determined to be “not of standard quality” (NSQ) owing to deficiencies caused by minor variations in the drug. Defects that arise as a result of insufficient pre-formulation checks, in-process controls performed by the supplier, or hazardous conditions. Counterfeit or fake drug products are formulations manufactured to conceal the product's true identity. Spurious drugs are made to imitate another drug, particularly any famous brand. Spurious products are typically developed by unlicensed anti-social elements. Adulterated medicines are those medicines that are found to contain an adulterant or substituted medicines. The Central Drugs Standard Control Organization (CDSCO) has issued notification about 49 products, including eye drops, pain relievers, vitamins, and even antibiotics. Out of the 1,336 samples tested, 1,286 were deemed to be of good quality, 49 were deemed NSQ, and one was deemed spurious. This study analyses the implications of violating the laws and regulations stated in the D&C Act by taking the example of a case brought against a pharmaceutical company that involved in manufacturing of NSQ drugs. The study stresses the need to follow the rules to ensure that the pharmaceutical or cosmetic product is made available to the individuals in the country with acceptable standards of quality, protection and efficacy.


Keywords:
  • Adulterated
  • Drugs and Cosmetics Act
  • CDSCO
  • Quality product
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How to Cite

TUMBAGI, A., V., B., NARMADA, S., & MISHRA, A. (2021). NOT OF STANDARD QUALITY DRUGS IN INDIA: A CASE STUDY. Journal of Case Reports in Medical Science, 7(3), 11-16. Retrieved from https://ikpresse.com/index.php/JOCRIMS/article/view/7391
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References

Bhattacharya N. Between the bazaar and the bench: Making of the drugs trade in Colonial India, ca. 1900–1930. Bull Hist Med [Internet]. 2016 Mar 1 [cited 2022 Feb 6];90(1):61– 91. Available: /pmc/articles/PMC5331622/

Drugs Enquiry Committee (D.E.C.), 1930 - history of drug legislation and pharmacy profession in India | Forensic Pharmacy [Internet]. [cited 2022 Feb 7]. Available:http://www.pharmacy180.com/article/drugs-enquiry-committee-(d-e-c-),-1930-1723/

Drugs and Cosmetics Act [Internet]. Available:https://www.nhp.gov.in/drugs-and-cosmeticsact_mtl#:~:text=The%20Parliament%20of%20India%20formed,conform%20to%20prescribed%20quality%20standards. [Cited 20 July 2020]

Khan AN, Khar RK. Current scenario of spurious and substandard medicines in India: A systematic review. Indian J Pharm Sci [Internet]. 2015 Jan 1 [cited 2022 Jan 22];77(1):2. Available: /pmc/articles/PMC4355878/

Regulator flags 49 out of 1336 drug samples as ‘not of standard quality’ and one spurious The Hindu [Internet]. Available:https://www.thehindu.com/news/national/regulator-flags-49-out-of-1336-drug-samples-as-not-of-standard-quality-and-one-spurious/article30594609.ece [Cited 2022 Feb 8]

Buckley GJ, Gostin LO. Committee on understanding the global public health implications of substandard F and CMP, Health B on G, Medicine I of. Causes of Falsified and Substandard Drugs. 2013 May 20 [cited 2022 Feb 8]. Available:https://www.ncbi.nlm.nih.gov/books/NBK202531/

Gujarat High Court, medipol pharmaceuticals India ... Vs State of Gujarat on 11 April, 2018. Available:https://indiankanoon.org/doc/2162788/ [Cited 24 July 2020]

Atorvastatin oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing - WebMD [Internet]. [cited 2022 Feb 8]. Available:https://www.webmd.com/drugs/2/drug-841/atorvastatin-oral/details

D&C Act and rules 1945 [Internet]. Legislative.gov.in. 2020 [cited 23 July 2020]. Available:http://legislative.gov.in/sites/default/files/A1940-23.pdf

India Code: Section Details [Internet]. [cited 2022 Feb 8]. Available:https://www.indiacode.nic.in/show-data?actid=AC_CEN_12_13_00023_194023_1523353460112§ionId=13995§ionno=3&orderno=3

The drugs and cosmetics Act, 1940 [Internet]. [cited 2022 Feb 8]. Available:https://indiankanoon.org/doc/1891720/

[Internet]. Cdsco.gov.in. 2019 [cited 25 July 2020]. Available:https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTY4
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