SpicyIP Tidbit: WSJ criticizes DCGI report on spurious drugs in India


The Wall Street Journal in its Sept 3rd edition carried an article by Dr. Roger Bate criticizing an exhaustive report on spurious drugs in India that was prepared jointly by the office of the Drug Controller Of India and the Indian Statistical Institute (ISI). This report which can be accessed over here was released late last year and was one of the most comprehensive reports on the prevalence of spurious drugs in India. (Please click here to access a well written summary of the report in the Mint). Dr. Bate belated criticism of the report questions the methodology adopted by the report in collecting samples for analysis.

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.

Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

4 comments.

  1. AvatarAnonymous

    The issue is not the statistical analysis at all which even Dr. Bate (not Bates) concedes is “well-conducted.” The issue is the data. The point being that well-conducted analysis with biased data can give you misleading results. In other words, garbage in, garbage out.

    In particular, what Dr. Bate claims is that retail pharmacists are aware of surveys being conducted and take care not to give fake drugs to the people conducting such surveys. This is not implausible.

    It follows then that the sampling methodology must find ways of overcoming this bias. Whether the study did this or not is unclear; Dr. Bate claims that the importance of the sampling protocol is discussed in one sentence and the actual protocol not discussed at all.

    I guess many of us, including myself, are so cynical that we would believe Dr. Bate rather than the government study. I would love to be proved wrong.

    As an aside, the movie which launched Amitabh, Zanjeer, had fake drugs as a theme. The movie came out in 1973 I think. If Dr. Bate is right, then it is disheartening to know that after 37 years, nothing much has changed.

    Reply
  2. AvatarAnonymous

    Prashant,

    Its ridiculous that you did not allow my comment to be posted regarding the NPPA and pricing issue; where I highlighted the issue of sub-standard and spurious drugs being circulated in India; due to which prices can be minuscule when compared to branded drugs.

    But I believe that might have opened up your grey matter and also the french beard of yours; because of which you posted this WSJ article.

    Just don’t harp only on one side of the coin; My advise see the other side also…..then you will realize the actual world.

    Regarding the article on WSJ; its self explanatory; nothing to comment on it. Mr. [and not Dr.] Bate has rightly pointed out the deficiencies in the Govt. Report and he being a foreigner has even pointed out the places where we can find fake drugs. This is for us to be shameful about.

    You can be well sure about the methodology adopted by CDCSO and how fallicious it could be.

    I know for the fact; that you will not post this comment also; but I will keep writing so that your grey matter is enlightened and your French beard shaved off!!

    Reply
  3. AvatarPrashant Reddy

    Anon (11:05 PM)

    Firstly – relax dude!

    Secondly – I shaved my french beard off 2 years ago.

    Thirdly – It’s Dr. Bate. He has a PhD. You can email him and ask him: [email protected].

    Fourthly – Your last comment on the NPPA post would have been allowed on this blog except for the fact that it was completely disparaging Cipla and its products. While you are anonymous and cloaked from any kind of liability, we at SpicyIP are completely open to being sued for trade libel. If you are ready to comment once again without abusing anybody, we will be more than willing to publish the comment.

    Fifthly – Stop flattering yourself 😉 I would have anyway covered Dr. Bate’s article regardless of your earlier comments. I’ve covered even his previous study along with Dr. Debroy.

    Regards,
    Prashant

    Reply

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