Clinical Trial Regulations in India

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Clinical Trial Regulations in India

Clinical Trial Regulations in India:


In simple terms, 'regulation' can be defined as a rule that has been designed to control and/or govern conduct. (1) Thus, a clinical trial is to be regulated for the purpose of safety. And, the regulations for conducting clinical trials in India are being prescribed under the following rules of Drugs and Cosmetics Rules (1945):

- Rule 122DA

- Rule 122DAA

- Rule 122DAB

- Rule 122DAC

- Rule 122DD

- 122E

- Schedule Y (2)

During 2013, the Central Drugs Standard Control Organization has issued a number of guidelines in order to strengthen the clinical trial regulations of the country. (3) This article will let you know about some of the important guidelines that regulate the process of conducting a clinical trial in India.

Rule 122- DAB, Rule 122 DAC and Rule 122 DD:

As we all know, clinical research is the major key for the discovery of advanced diagnostic methods as well as advanced drugs for the treatment of medical conditions. Clinical trial is definitely a positive requirement for striving towards the growing developments in the current pharmaceutical market across the globe. In India, in order to regulate such an important process, the Drugs and Cosmetics Rules, 1945 have been amended. Here are the details of those amendments:

Insertion of Rule 122-DAB (First Amendment): This particular rule is laying down the requirement of providing medical management at free of cost as long as needed in case of any injury that is occurring to the clinical trial subjects. This rule was extended like this: If the injury that is being suffered by the trial subject is linked to the particular clinical trial, then, he/she would be entitled for financial compensation according to the order of the Licensing Authority. Furthermore, if the clinical trial has led to the death of the clinical trial subject, then the financial compensation has to be settled to the nominee(s) of the deceased subject. In addition, the subsections of this particular rule would explain the circumstances which are being considered as 'direct nexus' to:

- An immediate cause to the injury or death

- Consequences of non-payment of compensation

Insertion of Rule 122-DAC (Second Amendment): This particular amendment to the Drugs and Cosmetics Rules, 1945 is specifying the prerequisites that are essential for any clinical trial to be considered as adequate so as to obtain the grant permission from the Licensing Authority for conducting that clinical trial on human beings. Further, this rule is laying down the power of the Licensing Authority to impose any extra conditions to be fulfilled for the purpose of obtaining grant permission with respect to any specific clinical trial.

Insertion of Rule 122-DD (Third Amendment): This particular rule is dealing with the compulsory registration of the Ethics Committee. This rule is also specifying that the Ethics Committee should not review and accord its approval to any clinical trial protocol without prior registration with Licensing Authority. Further, this rule is describing the procedure of registration that has to be made by filling an application to the Licensing Authority according to the requirements as specified in the Appendix VII.

For the purpose of streamlining the submission of application for clinical trial registration of Ethics Committee and their examination, it has been decided to establish a system of preliminary scrutiny of applications at the time of receipt in order to determine their acceptability by Central Drugs Standard Control Organization. (4), (5)

Brand New Regulation Process - Audio-Video Recording!

It has been recommended by the Drugs Technical Advisory Board that the audio-video recording of the informed consent process has to be carried out while performing clinical trials in the country. This particular regulation has been included as a draft rule in the Indian gazette (notification dated June 7th, 2013). According to this rule, audio-video recording of the informed consent process of each and every trial subject has to be made in addition to the written informed consent. This recording would include the procedure of providing information to the trial subject and his/her understanding on the informed consent when at the same time adhering to the principles of confidentiality. Such an audio-video recording that was done during the clinical trial process would be preserved.

This recording would help the government and community in re-assuring about the standards that are being maintained by the industry and/or institute while conducting the process of informed consent which in turn will lead to the increased faith of the society in clinical research. However, while doing so, prior consent of the trial subject must be obtained for such an audio-visual recording and the same must be documented by the investigator. It is to be noted that, only the subjects who are giving the consent for this recording will be included in the clinical trial.

Method of Audio-Video Recording: At the start of the audio-video recording process, the investigator would identify the clinical trial protocol, the clinical trial subject along with the language that is understood by the particular subject. In case, the investigator does not understand the language of the trial subject, a member of the study team who understands that particular language would act as the interpreter. For the purpose of identifying the subject, his/her photo ID might be documented.

As such, the video camera that is being employed for this audio-visual recording must be of adequate capability in order to simultaneously capture the facial expressions of the trial subject as well as the investigator in addition to any impartial witness and/or authorized person who are present during the informed consent process. This audio-video recording must be conducted in a room that is conducive to recording of the disturbance-free audio/video of the informed consent process. It is to be noted that this recording would not serve the intended process if the quality of your recording is failing to meet the minimum required standards. Finally, the recording and any other related documents should be preserved after the completion/termination of the clinical trial for a minimum of 5 years. (6), (7)


As the country is approaching towards globalization in the pharmaceutical sector, India is portraying to be a prospective hub for many global pharmaceutical companies in drug discovery. With the insertion of these regulations, it is expected that Good Clinical Practices will be a reality in the country. (4)









About the Author

Tharani Rajamanickam's picture

I am Tharani. I have Bachelors degree in Biotechnology. I am passionate about the healthcare and medical industry and continue to explore, learn and share and I bring in a wealth of knowledge and expertise to help you keep updated with current trends and developments. I have gained a lot of experience in clinical field by working in clinical trials arena. Stay tuned..

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