1. Ministry issues formula to determine quantum of compensation
in deaths occurring during clinical trials
The proposed formula will prove to be a great aid in computing
the quantum of compensation in the cases of SAEs of deaths
occurring during clinical trials. The criteria on which it is based
includes the age of the subject and the risk factor depending on
the seriousness and severity of the disease, presence of
co-morbidity and duration of disease of the subject at the time of
enrolment in the clinical trial. As per the new formula, the
compensation amount will vary from Rs. 4 lakhs - Rs. 73.60 lakhs
depending on the age of the deceased and the risk factor. However,
in case of patients whose expected mortality is 90% or more within
30 days, a fixed amount of Rs. 2 lakhs would be given. The expert
committee has also said that the trials can only be carried out in
accredited centers and the principal investigator and ethics
committee of the institute where the trial is being done, should
also be accredited. During the deliberations, the expert committee
felt that the criteria used to determine the quantum of
compensation should not be discriminative in nature due to
socio-economic conditions like income and education, and it should
not discriminate gender/sex. The criteria should not be such which
may have minimal impact but may create large variability and the
formula should be such that the inter group variability of
compensation value so arrived at, has little scope of discretion,
thus avoid possible bias.
PSA view -It is an appreciable development that
the formula has finally been created and introduced in public
domain. It would be good to see that at implementation stage the
formula is applied without any bias and no discrimination is caused
owing to factors such as income, sex, gender etc. Secondly, the
payment of compensation should be done in a timely manner,
otherwise this practice of creating the formula will be rendered
2. Latest notifications/developments
Ministry has confirmed that the National Institutes of Health
(NIH) under the US Government suspended enrollment of participants
in 35 interventional trials in India and raised concerns about how
these new requirements will be implemented, particularly the
specific provision related to compensation. The Health Minister Mr.
Azad also confirmed this in Parliament.
In a latest development, the DCGI has asked the sponsors of
clinical trials to furnish details of the contracts with the
investigators with regard to the financial support, fees and
payments in kind, while making the applications for trial
permissions. The Indian Society for Clinical Research has expressed
concern over the DCGI's intention in seeking this information
and another roadblock to a organized clinical trial
The proposed Drugs and Cosmetics (amendment) Bill pending in
Parliament has proposed to incorporate a separate chapter (11A) on
"Import, Manufacture, Sale, Distribution and Export of Medical
Devices." This will give the medical device sector the
necessary regulations and clarity in the framework which were
missing so far. The Bill also seeks to expand the scope of the
existing Drugs Consultative Committee by renaming it as "the
Drugs, Cosmetics and Medical Devices Consultative Committee,"
which will advise the government and other advisory bodies on any
matter tending to secure uniformity throughout India in the
administration of this Bill, when it becomes an Act.
Expressing discontent over the process and pace of collection
of overcharged amounts from defaulting companies, a Parliamentary
panel has asked the National Pharmaceutical Pricing Authority
("NPPA") to device mechanism to monitor
prices of non-scheduled formulations before introduction. On a
different note, it has also advised NPPA to adopt alternate tools
like arbitration to mitigate litigation cases. Meanwhile, the
Ministry has dropped the idea of setting up units of NPPA in all
PSA view - There has been a drastic decrease in
the number of clinical trials in the country. Though government has
taken several steps to improve the regulatory environment but steps
to boost the confidence of the investors are yet to be taken. There
are Bills still pending in the Parliament, which can further
streamline the pharma sector. Unless these Bills see light of the
day and the clinical trial regulations clarified to the
stakeholders, it would be difficult to ascertain when things will
improve. The recent judgement of the Supreme Court against Novartis
and the granting of compulsory license have already forced the
investors to think twice before setting foot in India. Certain
relaxation in FDI norms is too little a step to attract the
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