BMJ 2014;348:g60 doi: 10.1136/bmj.g60 (Published 7 January 2014)
Page 1 of 1
News
NEWS Counterfeit and substandard drugs in India may be smaller problem than claimed, say government findings Cheryl Travasso Mumbai
Only a very small fraction (0.05%) of drugs made in India and tested by the Central Drugs Standard Control Organisation between 2009 and 2012 were “spurious” (counterfeit) or substandard, government data have shown.
In 2009 the drugs agency published its Report on Countrywide Survey for Spurious Drugs concerning what it believed were mostly unverified and sensational reports that between 10% and 25% of Indian drugs were “spurious.”1 Spurious drugs are defined as those that are manufactured under another drug name or that wrongly claim to be another manufacturer’s product, or imitation drugs, or drugs that are partly or completely replaced with another drug.
The agency found that 11 of the 24 136 samples tested (0.046%) were spurious and that three of the 305 chemically analysed samples (1%) were substandard (these three contained between 85% and 89% of the active ingredients). For three years the agency then tested between 40 000 and 50 000 drugs each year. Of the 137 000 drug samples tested, 345 (0.003%) were found to be spurious and 6500 (0.05%) were considered substandard.2 The data were provided by India’s Ministry of Health and Family Welfare in response to a request made under right to information legislation.
In 2013 Ranbaxy USA, a subsidiary of the Indian drug manufacturer Ranbaxy Laboratories, agreed to pay a $500m (£330m; €385m) fine to settle charges relating to drug safety and fraud.3 The United States contended that certain drugs manufactured at Ranbaxy’s factories in Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) did not match the strength, purity, or quality required and were not aligned with the US Food and Drug Administration’s approved formulation.
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This is not the first time that India has been the subject of reports of counterfeit and substandard drugs. In 2003 Indian media alleged that a World Health Organization report had stated that 35% of the world’s fake drugs were produced in India. However, a health ministry report said that India’s drugs controller general had made inquiries on the subject to WHO, which then stated that there was no actual WHO study to support those conclusions.4 Nakul Pasricha, chief operating officer of PharmaSecure, a software and technology company that helps drug companies protect against counterfeiters, told the BMJ that the problem of substandard and counterfeit drugs in India was growing, although the statistics showed considerable variation. However, he noted that most of the top 20 drug companies were looking at technological solutions to curb the problem. Pasricha said that government legislation to improve awareness and protect drugs sold in India was vital, as well as consumer awareness programmes. 1 2 3 4
Central Drugs Standard Control Organisation. Report on countrywide survey for spurious drugs. 2009. http://cdsco.nic.in/report_book_13-7-10.pdf. Dabas M. Substandard, and not spurious, is the problem with drugs in India. DNA 30 Dec 2013. www.dnaindia.com/india/report-substandard-and-not-spurious-is-the-problem-withdrugs-in-india-1942567. Kay M. Indian generics manufacturer Ranbaxy agrees to pay $500m to settle US fraud and drug safety charges. BMJ 2013;346:f3536. Ministry of Health and Family Welfare. Report of the expert committee on a comprehensive examination of drug regulatory issues, including the problem of spurious drugs. 2003. http://cdsco.nic.in/html/Final%20Report%20mashelkar.pdf.
Cite this as: BMJ 2014;348:g60 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
Page 1 of 1
News
NEWS Counterfeit and substandard drugs in India may be smaller problem than claimed, say government findings Cheryl Travasso Mumbai
Only a very small fraction (0.05%) of drugs made in India and tested by the Central Drugs Standard Control Organisation between 2009 and 2012 were “spurious” (counterfeit) or substandard, government data have shown.
In 2009 the drugs agency published its Report on Countrywide Survey for Spurious Drugs concerning what it believed were mostly unverified and sensational reports that between 10% and 25% of Indian drugs were “spurious.”1 Spurious drugs are defined as those that are manufactured under another drug name or that wrongly claim to be another manufacturer’s product, or imitation drugs, or drugs that are partly or completely replaced with another drug.
The agency found that 11 of the 24 136 samples tested (0.046%) were spurious and that three of the 305 chemically analysed samples (1%) were substandard (these three contained between 85% and 89% of the active ingredients). For three years the agency then tested between 40 000 and 50 000 drugs each year. Of the 137 000 drug samples tested, 345 (0.003%) were found to be spurious and 6500 (0.05%) were considered substandard.2 The data were provided by India’s Ministry of Health and Family Welfare in response to a request made under right to information legislation.
In 2013 Ranbaxy USA, a subsidiary of the Indian drug manufacturer Ranbaxy Laboratories, agreed to pay a $500m (£330m; €385m) fine to settle charges relating to drug safety and fraud.3 The United States contended that certain drugs manufactured at Ranbaxy’s factories in Paonta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh) did not match the strength, purity, or quality required and were not aligned with the US Food and Drug Administration’s approved formulation.
For personal use only: See rights and reprints http://www.bmj.com/permissions
This is not the first time that India has been the subject of reports of counterfeit and substandard drugs. In 2003 Indian media alleged that a World Health Organization report had stated that 35% of the world’s fake drugs were produced in India. However, a health ministry report said that India’s drugs controller general had made inquiries on the subject to WHO, which then stated that there was no actual WHO study to support those conclusions.4 Nakul Pasricha, chief operating officer of PharmaSecure, a software and technology company that helps drug companies protect against counterfeiters, told the BMJ that the problem of substandard and counterfeit drugs in India was growing, although the statistics showed considerable variation. However, he noted that most of the top 20 drug companies were looking at technological solutions to curb the problem. Pasricha said that government legislation to improve awareness and protect drugs sold in India was vital, as well as consumer awareness programmes. 1 2 3 4
Central Drugs Standard Control Organisation. Report on countrywide survey for spurious drugs. 2009. http://cdsco.nic.in/report_book_13-7-10.pdf. Dabas M. Substandard, and not spurious, is the problem with drugs in India. DNA 30 Dec 2013. www.dnaindia.com/india/report-substandard-and-not-spurious-is-the-problem-withdrugs-in-india-1942567. Kay M. Indian generics manufacturer Ranbaxy agrees to pay $500m to settle US fraud and drug safety charges. BMJ 2013;346:f3536. Ministry of Health and Family Welfare. Report of the expert committee on a comprehensive examination of drug regulatory issues, including the problem of spurious drugs. 2003. http://cdsco.nic.in/html/Final%20Report%20mashelkar.pdf.
Cite this as: BMJ 2014;348:g60 © BMJ Publishing Group Ltd 2014
Subscribe: http://www.bmj.com/subscribe
