A few weeks ago, I got a call from the Editor of Quartz India. Sruthijith was surprised (shocked?) that his go-to-drug for cold was actually withdrawn elsewhere for safety reasons. Could I explain why it was okay for Indians to consume medicines that other countries balked at?
Now drug safety as some of you might have noticed over the years, is a bit of a pet peeve with me. But after working myself up time and again over it, I began to feel a bit like a stuck record. Now I only keep my fingers crossed and pray. (No, an activist I most definitely am not). I almost visibly slumped when I heard what he wanted. But then I roused myself. Surely, this was an opportunity for many reasons. The most important : more people read Quartz India than they do Apothecurry. But seriously, it was great that a general news website was interested in carrying an explanatory piece on drug safety. And without any horrifying news trigger like deaths or disabilities. Just because it is an important issue.
So I tried. I was warned, in no uncertain terms, to keep it simple and easy to understand for a lay audience. Now, as Somerset Maugham pointed out “To write simply is as difficult as to be good.” To my rescue came the words of Fortune magazine writer Sheridan Prasso whose writing workshop I once attended. “Write so your mother-in-law can understand.”
The result is here. It is lengthy and my thanks to Sruthijith for sparing the cuts. Many of you are from the drug industry and so won’t find any surprises here. But perhaps you could share this with your moms or mothers-in-law. Don’t give me their feedback though. I am a coward and experience has taught me they are ruthless.
Apothecurry 
Hi Gauri,
Well written and totally agree that India should have its own database and adverse drug reactions reported from its population to determine the benefitrisk profile of the drug and to justify to market it.
LikeLike
Nicely written article. There were times when a new combination product was introduced only because a company needed to introduce x number of new products! Further behind the changing stance of bans is also the commercial consideration of companies and how important the brands are to specific companies.
LikeLike
Hi Gauri!
I congratulate and appreciate you very much, for this comprehensive and sensible article! I am glad to see that your views on drug safety in India are balanced.
A major challenge to Indian pharmacovigilance is not only the lack of regulations and their implementation (especially in the postmarketing scenario) but also the dichotomy in our system. For example, the PvPI collects adverse events from clinicians and the CDSCO receives the PSURs from the pharmaceutical companies that submit them.
The safety data accumulated by the PvPI is not available to the concerned pharmaceutical companies and therefore, the PSURs they submit to the CDSCO do not contain these pearls of information. I would like to invite you to read my article on a similar topic by clicking on http://bit.ly/WbPRm1. Please do share your views with me in this regard.
With thanks & regards,
Dr J Vijay Venkatraman.
LikeLike
Thank you for pointing that out Dr Venkataraman. Perhaps the CDSCO should pass the PSURs on to the PvP for their records. That way, everything is captured in a single database. I don’t know if this is already happening.
LikeLike
Hi Gauri, while I agree to your views in the article, but there is another angle to the bans etc.whether it is a established market or a developing market. The role of vested interests in getting a drug banned or unbanned has also to be considered. Why is it that as soon as a big MNC launches a new drug for an indication which is patented to it, it suddenly finds that the old generic and cheaper drug available for the same indication has so many side effects that it has to be outrightly banned? Pioglitazone and Rosiglitazone were banned during the period when Sitagliptin was getting introduced in the markets.
LikeLike
Hi Sanjeev,
Thanks for reading and your relevant comment. One has heard several conspiracy theories to this effect. What we need is proof or lacking that rigorous research to examine if there is a a strong co-relation between new launches in a particular class or group of drugs and red flags being raised over the older substitutes. That would be up your alley, I think!
LikeLike
Brilliant blog Gauri!
LikeLiked by 1 person