How Do Generic Drugs Differ From Brand-Name Counterparts?
Generic drugs are an essential part of our healthcare system. Approximately 80 percent of prescription medications are generic, and a large percentage are produced overseas. Although generic drugs...
View ArticleHow Do Foreign Inspections Affect The Drugs We Take?
Low-cost generic drugs play a critical role in controlling escalating healthcare costs. With the vast majority of generics made partially or wholly overseas to capitalize on lower manufacturing costs,...
View ArticleThe Gold Standard
I have strong respect for the FDA and its dedicated staff. My eight-year effort to expose fraudulent activity at Ranbaxy has given me unique insight into how the FDA works and how it stacks up to...
View ArticleSatyamev Jayate – Truth Alone Triumphs
My eight-year journey for truth and justice came to an end on May 13. On that day, I stood in a U.S. courtroom as Ranbaxy pleaded guilty to multiple criminal felonies and agreed to pay $500 million to...
View ArticleRole of National Regulators in Ensuring High-Quality Drug Supply
One of the key determinants of high quality, safe and effective medicines is the role of a national drug authority in holding pharmaceutical manufacturers accountable for violating cGMP standards. The...
View ArticleWhat can we do about adulterated drugs?
There have been questions raised in the last few weeks as to what it means when the U.S. FDA says a particular drug is adulterated. Although the U.S. FDA has clear criteria by which the agency...
View ArticleHow Do Processes and Standards Affect the Quality of Drugs?
The discussion in India following the resolution of my case against Ranbaxy has been primarily focused on violations of processes that the U.S. Food and Drug Administration (U.S. FDA) requires...
View ArticleRisk-based assessment of compliance with cGMPs
Compliance today is continuous process of assessing and eliminating or minimizing risks associated with the manufacture of pharmaceutical product. The key objective of Current Good Manufacturing...
View ArticleWhat do we do about drug shortages?
On February 25, 2009, the U.S. FDA imposed on Ranbaxy what is akin to a death penalty if you are a pharmaceutical manufacturer: it invoked the Application Integrity Policy1. It cited numerous instances...
View ArticleA Brief Hiatus
Thank you for tuning into my blog. I am taking some time off for the next few months but look forward to re-engaging with you all in the fall.
View ArticleA sincere attempt to improve the quality of medicine for people around the world
For over two and half years now, I have tried very hard to convince the Indian government to do something about the widespread prevalence of substandard drugs in the country. A recent report puts the...
View ArticleCentralising drug licensing in India: The ‘holy grail’ of drug regulatory...
One of the main reasons for the abysmal quality of drugs in India is the multiplicity of regulators. The nation of India, which is a common market, has 36 different drug regulators – 1 each of each...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 1:...
In the next series of blog posts, I will try and explain how the current regulatory structure encourages the manufacture and distribution of substandard medicine in India. These are the arguments we...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 2:...
In my previous post, I explained how unscientific and dysfunctional the sampling process is that is used by both State and Central Drug Inspectors to establish the quality of commercially available...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 3: ‘Casual,...
In my last post, we looked at the investigation process followed by drug inspectors of the Andhra Pradesh Drug Control Administration in three different cases. In this post, lets look at the...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 4: A land...
In the last two posts, I explained how investigations are conducted in Andhra Pradesh and Maharashtra. In this post, I will discuss two investigations in Vellore district of Tamil Nadu. Unlike other...
View ArticleThe CDSCO’s bravado on surprise checks
A couple of days ago, the Economic Times (ET) reported quoting an anonymous source that the CDSCO would soon begin conducting surprise checks for compliance with regulatory standards at pharmaceutical...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 5: A...
In the series of blog posts leading up to this one, we have looked at how various state health regulators conduct investigations and initiate prosecution where they have a preponderance of evidence for...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 6: The...
When we began our research into India’s drug regulatory system last year, one of the first topics that we sought to study was the creation of the Central Drug Standards Control Organisation (CDSCO) and...
View ArticleEnforcement measures under the Drugs & Cosmetics Act, 1940 – Part 6: Who...
One of the issues raised in the 59th Report of the Parliamentary Standing Committee on Health & Family Welfare was that of appropriate qualifications for the post of the Drug Controller General of...
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