The DCGI’s report titled ‘Report on Countrywide Survey for Spurious Drugs’ was commissioned in light of sensational media reports which pegged the figure of counterfeit drugs in the market at 35%. In the ‘Executive Summary’ of the report the DCGI puts the figure of counterfeit drugs at a comforting 0.3%. The DCGI also strongly debunks the oft-repeated figure of 25% to 30% of counterfeits as unverified and often wrongly attributed to the World Health Organization (WHO) which itself has disclaimed making any such statement.
For the purposes of the survey, 24,125 drug samples, belonging to 9 therapeutic categories and spread over 61 popular brands were collected. Of all these sample only 11 were rejected by manufacturers, on a physical examination, as not being manufactured by them i.e. 0.046% of the entire batch. Of the 305 samples subjected to chemical analysis only 3 were found to be substandard with respect to content of the active ingredient mentioned on the label i.e. 0.101% of the entire study. An additional 2,671 samples which were subjected to testing on the orders of the Ministry of Health showed 100% conformity.
The report also carries out a comparison with a prior SEARO/WHO report which had pegged the level of counterfeits (on physical examination) in the Indian market at 3.1% against the DCGI’s finding of only 0.046%. While the SEARO/WHO report states that atleast 0.3% of the samples subjected to a chemical analysis failed in meeting the standards specified in the labels, the DCGI report states that only 0.101 % failed to meet the standards specified in the labels when subjected to a chemical analysis.
In his article Dr. Bate summarizes the DCGI report as a ‘well-conducted analysis of probably dubious data’. He states that ‘It’s reasonable to assume that the report generated untrustworthy findings because the samples were biased’. He bases these assumptions on an earlier study which he conducted along with noted Indian economist Dr. Bibek Debroy. That study had pegged the number of sub-standard drugs at 5% of all samples in Chennai and at 12% of all samples in Delhi. These numbers would appear highly inflated in light of the DCGI study.
While I will not comment on the statistical analysis, as I have no expertise in that area, I would like to point out that the DCGI should have stuck to the definitional framework laid down in the Drugs and Cosmetic Act, 1940 i.e. it should have classified the drugs as either “Adulterated drugs” (Section 17A) of the Drugs and Cosmetics Act, “Spurious Drugs” (Section 17B) or “Mis-branded” (Section 17). The term ‘counterfeit’ that the DCGI uses in its report is not found anywhere in the Drugs and Cosmetics Act, 1940.