LUKOSIN: A classic “magical” remedy

I got drawn to the magical remedies of AIMIL Pharmaceuticals early last year and had tweeted about some of their products, two of them BGR34 and Lukosin caught my attention, not only because of the flaunting of DRDO’s logo on the website of this private pharmaceutical company (for Lukosin and a modest mention of the know how by CSIR on the former), but also because of the claims made about cure (not treatment) of Vitiligo. 

Lack of (quality) trials

These products have not been rigorously tested to examine their safety and efficacy. Both safety and efficacy are of paramount importance when it comes to making public claims about a product having pharmaceutical action. Indeed, there is an entire Act governing “…control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith” nicely titled THE DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT, 1954. Indeed both Vitiligo and Diabetes are specified conditions for which this act applies. However, on searching through peer-reviewed literature, I was not able to come across a single published clinical trial that establishes either the safety or the efficacy of either of these medicines.

Evidence presented by the company is an example of how not to do a clinical trial

The only article available as evidence is the one supplied by the company along with a colourful leaflet of their product. See the article here. The article has several fundamental issues:

  1. Unknown journal Medicine Update where this is published. Only appears among UGC approved list of journals (psst…indication of predatory nature check)
  2. No mention of any ethics clearance/oversight
  3. Not registered as a trial
  4. Co-authored by Executive Director of the Pharmaceutical company
  5. 100% efficacy established(!): 65% fully recovered and rest 35% were in the phase of recovery(!)
  6. Abstract and conclusion are a pleasure to read but in no way fulfil being a fair summary of the study
  7. Medicine was given to 600 patients and results provided for 100(!?)

…and so on.

Advertising standards

The advertisements clearly violate basic translation of what we know about these products and potential buyers need to be protected, more so when the company uses logos of DRDO and branding of CSIR, both of them public agencies of some reputation. It is also unclear what kind of agreements/MoUs govern the use of these logos for pharmaceutical marketing purposes.

Thankfully, the Advertising Standards Council of India (which is a self-appointed industry regulator) identifies the product as violating industry standards in advertising codes. See here.

And Preeti Mandal, a doctor/MBBS student has taken the efforts at explaining this elaborately in a quota article here

Anyway, based on this, I have written to various relevant public authorities to take action.

Of all the actors, the ASCI, an industry self-regulating mechanism was the most responsive. See their judgement on my complaint upholding the assertions made in my complaint to them.

The drugs controller responded indicating his inability to act on Ayurvedic medicines, for which he pointed me to AYUSH department, which does not have any mechanism for quality control and/or regulation that is available (to my knowledge from the website).

Response from the Drugs Controller of India to the complaint on Lukosin/AIMIL Pharmaceuticals


Comments

4 responses to “LUKOSIN: A classic “magical” remedy”

  1. The correct quora link: https://www.quora.com/Could-you-elaborate-about-Lukoskin-Is-it-advisable-for-vitiligo-patients-having-a-lot-less-lesions-Some-say-it-will-trigger-the-system-and-more-patches-will-appear-Is-it-so/answer/Preeti-Mandal-7

    It surely cannot be the patient’s responsibility to look at scientific literature before buying drugs. Can we prosecute doctors if they prescribe such drugs?

  2. Thanks. Corrected the link. It’s a bit tough to answer your question though. “Such medicines” (read magical remedies) are widely available. On one hand there is a need to ensure that our strict regulations do not infringe upon people’s right to practice and/or obtain traditional remedies, while on the other, these regulations must protect people from advertising malpractices and misleading claims. This clearly falls in the latter, though it possibly hides behind being “herbal”/”Ayurvedic”. If a doctor is merely pointing to a product that is available in the market (and even having endorsement(?) from CSIR/MoD, I wonder whos to blame…

  3. Venkatesh Panduranganath Avatar
    Venkatesh Panduranganath

    Good effort prashanth doing am eagle’s eye job and reporting to the agency

  4. Venkatesh Panduranganath Avatar
    Venkatesh Panduranganath

    In fact I too have come across 2 similar instances in distant memory of mine, cant figure out what were those

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