Dozens of New Drugs permitted without trial even as unregulated Drug Trials Killed 47 Indians in three years

The union health ministry has permitted entry to dozens of new drugs in the Indian market without the mandatory drug trials at the local level even as poorly regulated drug trials killed 47 Indians in last three years.

Official data released by the union health ministry shows that these deaths occured between 2014-16, all attributed to 'Adverse Events' related to clinical trials.

The break-up of deaths show that 2014 led to maximum number of causalities at 23, followed by 13  deaths in 2013 and 11 in 2016. These deaths happened out of 1202 reported 'Adverse Events' during these three years.







Explaining the cause of these clinical trials related deaths, union health minister Jagat Prakash Nadda told Parliament in a statement on 2 January, 2018 that 'death may occur during clinical trial due to various reasons such as the disease from which the patient may be suffering or due to the investigational product or any other reason.'.

But is it the complete truth is a moot question as lure of easy money forces many of these poor drug trial victims to fall prey by volunteering to different trials without any concern about their health.

Closer home, it may be recalled that Karimnagar has turned into the hub of unregulated drug trials what with the death of Vangaraju Nagaraju of Nagampeta village last year still fresh in mind.

In this context, it is surprising to learn that the union health ministry allowed entry of dozens of new drugs in the Indian market without even testing them on Indians. What if these newly permitted drugs do not suit the physiological make up of Indian patients, leading to adverse effect?





Latest data shows that as many as 47 new drugs were approved for manufacture/marketing in the country without local clinical trial.

The official explanation for this backdoor entry of these drugs was that 'Under certain conditions, such as for drugs indicated in life threatening/serious diseases or diseases of special relevance to the Indian health scenario and in public interest, the clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority'.

So, what are these new drugs?