Clinical trials: a step towards ironing out regulatory ambiguities

In 2005, India was the ‘go to’ destination for conducting clinical trials. However, recent articles indicate that, since then, the growth trajectory of the clinical trials industry 
in India has suffered due to the lack of clarity in the regulatory framework governing these trials.

In order to resolve the ambiguity under the current regime and to meet the increasing demand of the industry for monitoring of clinical trials, the government of India is in the process of reforming the regulatory procedures on clinical trials.

To meet this objective, the government has proposed amendments to the principal legislation ie the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetic Rules 1945. These proposed amendments are under three broad headings which are:

  1. conditions for conduct of clinical trials;
  2. regulations in relation to the ethics committee; and
  3. compensation to the study subjects.


To some extent, the Good Clinical Practices (GCP) Guidelines contain certain aspects of the above proposed amendments. Although in terms of Schedule Y of the Drugs Rules, the GCP Guidelines are required to be complied with while undertaking clinical trials and the approval of the ethics committee is a prerequisite, it appears that, for the purpose of eliminating any ambiguity as to its compliance and to harmonise the conditions with the principal legislation, it is proposed that the Drug Rules specifically provide for compliance with the GCP Guidelines and seeking approval of the ethics committee as a precondition for initiating a clinical trial.

A further condition for conducting clinical trials, as proposed in the amendment, is the registration of a clinical trial with the Clinical Trial Registry. Though this condition was introduced by the drugs controller general of India (DCGI) with effect from 15 June 2009, no amendment was made to the Drug Rules to reflect the same. The conditions also provide that the sponsor will be responsible for submitting an annual status report on the clinical trial to the DCGI.

Under the present regulations there is no time frame prescribed for the submission of status reports by the sponsor. The regulations simply provide that the sponsor is required to submit status reports at the prescribed periodicity. Another important condition proposed is the obligation of the sponsor to provide medical care and compensation in case of trial-related injury or death. Presently the Drug Rules do not provide for compensation as a mandatory obligation of the sponsor. It is under the GCP Guidelines that a sponsor is required to only agree to provide compensation. Other conditions proposed are the requirement to communicate suspected serious adverse reaction to the DCGI and inspection of the clinical research organisation (CRO) sites by the Central Drugs Standard Control Organization (CDSCO). These conditions already form part of the GCP Guidelines, 
the effect of these amendments coming 
into force will be the synchronisation of the GCP Guidelines with the Drug Rules to a certain degree.

The proposed amendments also provide for consequences for non-compliance of the conditions that do not form part of the existing regulations. The consequences are:

  1. issuance of a warning letter by the DCGI to rectify the non-compliance;
  2. recommendation that the clinical study be rejected;
  3. suspension/cancellation of the trial permission; and
  4. imposition of restriction on the investigator, sponsor, CRO to conduct future trials.

These ramifications will act as a deterrent and induce the parties that could be affected by it to take compliance of these conditions seriously.


While the GCP Guidelines on one hand provide for payment of compensation to the subjects for any temporary or permanent disablement or injury caused as a result of the trial, they do not impose any binding obligation on the sponsors for payment of such compensation. This creates a dichotomy; in terms of the GCP Guidelines the sponsor is supposed to agree, before the research begins, to provide compensation for any serious physical or mental injury of the subject or to provide insurance coverage for an unforeseen injury. Given the importance of compensating the trial subjects and the lack of clarity as to the responsibility of payment, the government has proposed to make 
specific provisions with regard to payment of financial compensation to the trial subjects in the Drug Rules.

The proposed amendment specifies that the sponsor will be responsible for bearing the expenses relating to the financial compensation. Once these amendments are notified, the sponsor will be required to give an undertaking for the same before the trial commences and the quantum of the minimum compensation will be mentioned in the informed consent document. The details of the compensation will also be required to be intimated to the licensing authority. The amendments also encompass the time frame and procedure for the payment of compensation.

Additionally, consequences of failure to provide such compensation are envisaged in the amendments. These consequences are the suspension or cancellation of the clinical trial or restricting the sponsor/CRO from conducting any trials in the future. In this manner, the government has sought to put to rest the issues relating to payment of compensation affecting the clinical trials industry. In this respect, the CDSCO has issued draft guidelines setting out the criteria for determining the quantum of compensation in case of clinical trial related injury or death.


In relation to the ethics committee, the amendments seek to provide for a definition and composition of the ethics committee basis of the GCP Guidelines. In addition to the provisions under the GCP Guidelines, the proposed amendments seek to lay down the qualifications of the members of the ethics committee. It is also proposed that the ethics committee be registered prior to according any approval to a clinical trial. Additional responsibilities, such as reviewing the serious adverse event reports, recommending compensation in cases of injury or death and facilitation of inspection of the trial sites also form part of these amendments. The objective of the government is to regulate the ethics committee given the significant role that it plays vis-à-vis clinical trials.

Even though the proposed amendments are a step towards improving the existing regulatory framework, there is still a long way to go in strengthening the law governing clinical trials. Issues relating to the obtaining of informed consent, transparency et al require serious consideration. This will not only be favourable for the trial subjects but will also be useful from the perspective of sponsors, CROs and investigators.