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Supreme Court directs MoHFW to provide details of deaths and SAE
The 10th hearing of the writ petition filed by Swasthya Adhikar Manch took place today before a bench of the Supreme Court consisting of Justice R.M Lodha and Justice Kurian Joseph. The case was filed in February, 2012 and the last hearing was held on 31st January, 2014. The court today, directed the Ministry of Health and Family Welfare (MoHFW) to provide details of deaths and SAE as mentioned in the following table by the petitioners along with details of 506 cases of SAEs who have not been compensated.


Serious Adverse Effects (SAEs), Deaths and Compensation


SN

Type

Jan 05 to June 12

July 12 to Dec 12

Jan 13 to Dec 13

Total

1

SAEs

11972

1226

1122

14320

 

2

Deaths

2644

224

590

3458

 

3

Total

14616

1450

2938

17778

 

4

SAEs due to trials

506

No information

No information

506

5

Deaths due to trials

80

9

No Information

89

6

Compensated only in deaths not in SAEs

80

9

No information

89



The Respondent-Ministry has admitted that the information regarding deaths/SAEs caused by clinical trials have been provided by drug companies. It has not come on record whether the total number of deaths/ SAEs have been verified by the DCGI and MoHFW.

The Ministry has not been forthcoming about details regarding the approval, specifically whether the approvals were granted by the Technical Committee and the Apex Committee only after considering the three parameters, which were directed to be followed, i.e. (i) safety and efficacy, particularly in terms of risk and benefit to patient; (ii) innovation vis-à-vis existent therapeutic option; (iii) unmet need in the country.

Further, the Ministry has not disclosed important details regarding new chemical entities. The Supreme Court directed the MOHFW to file a detailed response within 4 weeks. The MOHFW had already confirmed that the 215 gas-victims who were subjects of clinical trials were not paid the requisite compensation and that the Serious Adverse Events (SAEs) including death cases were not reported in time. The petitioners also raised a point about Dr. Ranjit Roy Choudhary, being a member of the Technical Committee.

Neither our country nor citizens are deriving any benefit from clinical trials of new chemical entities. If these new chemical entities were actually beneficial, they could easily be used in our country after following due procedure. The question to be asked is why Indian subjects are used for testing new chemical entities by multinational pharmaceutical companies. There is obviously no rational answer, which could indicate the existence of any national or public interest.

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