Snippets: Draft Guidelines on Reporting Serious Adverse Events in Clinical Trials

A few days ago I was in a meeting as part of the Ethics Committee of the National Heart Institute, New Delhi and it struck me that drug laws and related issues, such as clinical trials, haven’t received rigorous critical attention, barring instances where the debate on pharmaceutical patents has stirred public interest occasionally.

Even in these debates, drug laws themselves have rarely been discussed and critiqued. This led me to decide that this is an issue which is best addressed holistically along with the Great Indian Pharma IP debate, instead of compartmentalizing different aspects of the pharma business.

To start with, early this May, draft guidelines on reportage of “Serious Adverse Events” in clinical trials were proposed by the Drugs Controller General of India (DCGI) and comments were invited on the draft guidelines. Only a fortnight was allotted for submission of comments, which I think is too narrow a time-window.

Ideally, submission of comments ought to have been allowed for 2 months, which would have given stakeholders sufficient time to get their organizations moving and to come up with meaningful suggestions. Nevertheless, one hopes the DCGI is not too rigid about the deadline.

We welcome our readers to share with us their suggestions on the draft guidelines.

Image Courtesy: www.cartoonstock.com

Chinese Counterfeits Undermine Indian Generics

This Monday, I read an article in The Mint titled “Made in India, Faked in China”, written by Roger Bate. This article seems to have captured even the attention of the Indian Government, so much so that one can read it on the website of the Ministry of External Affairs.

Roger Bate is someone who has done extensive work on counterfeit drugs and their implications on public health. From what little of his work that I have read, he believes in calling a spade a spade.

In this article on counterfeit Chinese drugs, he says that while the developed world is pre-occupied with India on the issue of counterfeit drugs which emanate from here, “a vast Chinese network behind the fakes is getting away”.

He backs this claim with an empirical study that his team has undertaken since 2006. Here’s the relevant portion of the article:

“My research team collected drugs from 22 cities in 20 countries over the past four years. Of these, 911 antimalarial and antibiotic products were, according to their packaging, made in India. They were procured from 14 countries, mainly in Africa, but also in Thailand and India. Of those products, 79 (or 8.7%), failed basic quality control tests and hence were unfit for their intended use. Of these 79 products, we were able to establish that 37 were counterfeits. 

More products may have been counterfeit, but without responses from the manufacturers or regulatory agencies, it was not always possible to be sure. Of the 37 counterfeits identified, 22 were definitely faked in China and delivered straight to African nations from China. Hence, from our small sample, over half (59%) of the fake Indian drugs were actually made in China.” 

Dr.Paul Orhii, head of Nigeria’s anti-counterfeit drug agency, who helped Bate with his study, discovered that there were vast Chinese criminal networks which had successfully infiltrated every aspect of drug production and distribution.

Bate, in fact, goes to the extent of saying that even counterfeits found in India could be largely of Chinese origin...Should we be probing another angle to this issue...namely State-sponsored counterfeiting?

Most of these drugs apparently source their origins to the Shenzhen free-trade zone in China. Given that China isn’t exactly a democracy as we understand it, State supervision is usually presumed, particularly in commerce. Is it possible that the Chinese State has absolutely no knowledge of manufacture of counterfeits in its most popular and successful Special Economic Zone?

Empty speculation without further research may not do justice to a topic of such gravity...I’ll write more on this after further reading.