Half Knowledge is Dangerous – Regurgitating talking points is even worse
The Hindu published an opinion piece a few days back titled “Taking a myopic view of foreign made generic drugs” by Srividhya Raghavan, Professor of Law at Texas A&M University on July 9, 2019....
View ArticlePOST-MARKET QUALITY SURVEILLANCE PROJECT MATERNAL HEALTHCARE PRODUCTS...
A study, funded by US-Aid & run by the U.S. Pharmacopeia, was performed in Ghana on two life-saving medications used during labor — Oxytocin & Ergometrine. The results were both astonishing and...
View ArticleIndia’s generic pharma industry is trying to rollback mandatory stability...
One of the most shocking discoveries during the course of my research into the Indian drug regulatory system over the last few years were the minutes of the 46th meeting of the Drugs Consultative...
View ArticleJudicial and policy quackery behind the regulatory restrictions on Oxytocin
Author: Prashant Reddy Thikkavarapu, republished with the author’s permission from the original SpicyIP post There has been panic and alarm amongst doctors, especially gynecologists, since the...
View ArticleHistory doesn’t repeat itself, it rhymes
The Economic Times reported today of my petition to the Prime Minister to hold the Ministry of Health and Family Welfare to account for all the promises it made to the Parliament of India over several...
View ArticleBuclizine: A reminder of lack of accountability at the Ministry of Health
According to a recent report in the Mint, the Drugs Technical Advisory Board (DTAB), a statutory authority under the Drugs and Cosmetics Act, 1940 was to meet this week to deliberate amongst other...
View ArticleIncentivise Integrity
The following piece was published in the Indian Express (although abridged) on March 13, 2018 A common theme among the pundits these days on Television and in Newspaper articles is whether the country...
View ArticleThe fate of the much-hyped mandatory generic prescription plan
It appears that the Ministry of Health has put a kibosh on the much-discussed mandatory generic prescription plan after all. Newspaper reports say that they have advised the Prime Minister’s office of...
View ArticleThe misplaced propaganda about evolving standards
When the story about Ranbaxy pleading guilty to seven counts of criminal felony broke in May 2013, the standard response across the Indian pharma industry and the Indian drug regulator CDSCO was that...
View ArticleNational List of Essential Medicines and Price Caps
It has been widely reported that an RSS Affiliate (Swadeshi Jagran Manch) has taken issue with the recommendation of the Niti Ayog to delink the Drug Price Control Order (DPCO) from the National List...
View ArticleAffordable Generic Drugs: The end-game
This is my last blog in the series discussing affordability of medicine in India. In my past blogs, we have tried to understand the problem, the nomenclature that confounds this issue, and elements of...
View ArticleAffordability: What does procurement have to do with it?
In the last blog, we looked at how we can enable pharmaceutical manufacturers to use quality as a differentiator and empower the citizens of our country to make more informed decisions about the...
View ArticleA step toward affordability
In this series of blog posts, I have described the challenges with the proposed simplistic approach to make drugs affordable, including the nomenclature we use, the factors confounding the problem and...
View ArticleGeneric prescriptions: Do we want a nanny state?
In my last two blogs, I have tried to outline the complexity of the problem when it comes to affordability of medicines in India. In this post, lets take a look at a few factors that confound the...
View ArticleTransaction Price Vs Long Term Outcome: What does the data say about...
Now that we understand what “generic” means in the Indian context, lets look at whether we have any historical evidence of these “generic” medicines actually saving us money. The only studies that I...
View ArticleThe real answer to affordability
Over the last two weeks, there has been a spirited debate about how to make medicines affordable to the citizens of India. Driven by the Prime Minister’s call to make less expensive medicines available...
View ArticleAn open letter to K L Sharma
Shri K L Sharma, Joint Secretary (H), Ministry of Health and Family Welfare Dear Shri Sharma, If you recall, I met you in May 2015 after the PMO forwarded my letter to them to you for your...
View ArticleWill we ever learn?
There is news today that the US FDA made observations about Sun Pharma’s facility at Mohali that are very similar to what led to the import alert for products manufactured at this facility back in...
View ArticleDifferences in approach to regulation: why leadership and science matters
In my past blogs, I have documented how the CDSCO and the Drugs Consultative Committee (DCC) have taken decisions that adversely affect public health and give the industry a free pass even in cases...
View ArticleRevision to the Drugs & Cosmetics Act – Call for public comment
On June 6, 2016 the CDSCO published a notice announcing that it was going to revisit the Drugs & Cosmetics Act, 1940 and Rules, 1945 “to match up with the current regulatory requirements related to...
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