REGULATING CLINICAL TRIALS

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 futile.

2. Latest notifications/developments

  1. 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.
  2. 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 environment.
  3. 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.
  4. 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 the states.

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 investors again.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.