EXTRACT FROM SURVEY OF SPURIOUS DRUG REPORT

EXTRACT FROM SURVEY OF SPURIOUS DRUGS REPORT GOVT OF INDIA
BY MANOJ TONGRA DRUGS CONTROL OFFICER RAJASTHAN email manojtongra@gmail.com
+919414002377
The “Report on Countrywide Survey for Spurious Drugs” is published by CDSCO on behalf of
Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India. The survey
report is produced to fulfi ll the requirements prescribed in the Drugs & Cosmetics Rules-1945 for standards of
drugs produced and /or marketed in India and contributes in control of quality of the medicinal products.
The quality of Drug formulations has been a prime concern at National as well as International level.
Circulation of spurious drug can lead to grave & adverse consequences on both consumers (patients) and
genuine manufacturers. According to the report received from various State Drug Controllers, the extent of
circulation of spurious drug in Indian retail market is about 0.3%. However, media often magnifi es it, in a sensational
manner, between 10-25% which is mostly unverifi ed. Indian Pharma Industry expressed displeasure
over the repeated projection of Indian Pharma Industry as major producers of spurious drugs in the world.
Due to dire consequences on public health in view of various projections regarding circulation of spurious
drug, a systematic study was necessary to assess the actual extent of spurious drug circulation in the community
at large.
Report on Countrywide Survey for Spurious Drugs would, no doubt, provide relevant information about the
fl ow of Spurious drugs in National market and bring awareness among the community. Perhaps this is the
fi rst time in world history such a scientifi c study has been carried out by collecting huge number of samples
involving consumer associations and other NGOs. It is expected that people at large will be immensely
benefi ted through this report and their belief in availability of quality medicines in India will be assured &
strengthened.
The sample collection and its verifi cation was a mammoth task and involved strenuous day and night work
on part of NGO’s, CDSCO Offi cials & Laboratories over a period of 7 Months. The team work to bring out
the actual fi gures on extent of problem of spurious drugs in the country is appreciable.
The survey report covers summary of sampling, results, interpretation and gives information about present
scenario of circulation of spurious drugs all over India. Detailed information on determination of sample size
for estimation of counterfeit drugs, format for recording the details of sample drawn and amendments done
in Drugs & Cosmetics Act-1940 are annexed.
Executive Summary
1.1 Background: Circulation of spurious drug can lead to grave, adverse consequences on both consumers (patients)
and genuine manufacturers. According to State Drug Controller, the extent of circulation of spurious drug is about 0.3%.
However, media often magnifi es it, in a sensational manner, between 10%-25% which is mostly unverifi ed. Due to dire
consequences on public health in view of circulation of spurious drug, a systematic study was necessary to assess actual
extent of spurious drug circulation in the community at large.
1.2 Methods : Samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic
categories (anti-infective, anti-malarial, anti-T.B.Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs,
and multivitamin preparations), were collected between November & December 2008. Samples of 61 popular brands of
the above mentioned class were collected. Collection of samples of each brand were made from retail pharmacy outlet
(25 each from metros, big cities, district head quarters, towns and villages) in each zone of CDSCO (East, West, North and
South) with the help of NGOs and consumer associations, who in turn, collected drug without prescription from retail shop
by acting as surrogate patients. Details of the sample (name of drug, brand name, expiry date, batch number, address of
retail pharmacy outlet, etc.) were recorded as per preset format and samples were stored as per required storage conditions.
Samples collected were handed over to authorized quality assurance person of the respective manufacturer for identifi cation
by physical examination so as to establish the authenticity and were asked to return the samples with comments for
undertaking further chemical analysis.
From the samples which were accepted by the manufacturers as genuine product (24,125), fi ve drug samples of each
brand were randomly selected and were subjected to further chemical analysis in Government testing laboratory (Indian
Pharmacopoeia Commission) and Private Testing laboratory (M/s Arbro Laboratory, New Delhi).
Later, on the direction of Ministry of Health & FW, an additional 2,671 samples were also sent for chemical analysis
(11.072 % of the collected samples which were accepted by the manufacturer as genuine i.e. 24,125).
1.3 Findings : Most of the pharmacy retail shops in metro cities refused to sale the scheduled drug without prescription
and in towns and district head quarters there was tendency to replace one brand with other brand. Though most of the drugs
were not available in retail pharmacy outlets, located in villages, availability of all selected brands was uniform throughout
the country. Most of the retail shop did not provide cash memo without request and at times even with request. A total of
24,780 samples were collected by visiting around 40,000 pharmacy outlets, of which 644 samples were of SALA (Sound
Alike and Look Alike). Of remaining 24,136 samples, only 11 samples were not accepted by manufacturers as their genuine
product by physical examination. These unaccepted samples were mainly from Bihar, West Bengal, UP and Gujarat states
accounting fi ve, three, two and one sample respectively. However, none of these samples failed in identifi cation test.
Of 305 samples subjected to chemical analysis, only 3 were found to be substandard with respect to the content of the
active ingredient mentioned on the label (reported results are 86.0, 89.3 and 84.8%). Additional 2,671 samples, which were
subjected to testing on the direction of Ministry of Health & FW, showed 100% conformity with respect to identifi cation and
assay as reported by the government analyst at various central government testing laboratories.
1.4 Interpretation: The extent of spurious drug in retail pharmacy is much below the projections made by various
media, WHO, SEARO, and other studies i.e. only 0.046 % (11 samples out of 24,136 samples).
1.5 Funding: Ministry of Health & FW, Govt. of India
12.0 Conclusions:-
In view of above observations and data obtained from the manufacturers, after physical verifi cation of all the
drug samples and subsequent chemical analysis report on
the representative of samples taken at random, it may be
concluded that:
(i) The extent of spurious drug in retail pharmacy
is much below the projections made by various
media, WHO, SEARO, and other studies i.e. only 0.046 %
(11 samples out of 24,136 samples).
(ii) Extents of substandard drugs among the branded
items are only 0.1 % {Out of two thousand nine hundred
seventy six (2976) unsuspected samples, 03 samples do
not conform to claim with respect to Assay on chemical
analysis}.
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