In the clinical research industry, safety norms and processes should be applied to every aspect, starting from drug development to post-marketing use of approved drugs, keep in mind patient safety and data credibility at every stage of clinical development.

Patient safety requires collaborative effort of the regulatory system, healthcare system, and the sponsor. Equally important is the need for effective communication to patients by the regulatory bodies and health care systems to maintain transparency. Such communication also help in instilling confidence in patients about the scientific credibility of the trial. For instance, the Central Drugs Standard Control Organization (CDSCO), India uses information technology to keep the public aware about ongoing and completed trials. All data starting from filing of application to the trial results are available on the website. Sponsors, clinical research organizations, as well as ethics committees are required to furnish their details on the website. Data safety and monitoring boards (DSMB) are also formed to monitor trials, especially large trials, for safety and reliability of data. DSMBs play a significant role in letting the public know if the investigational drug poses any threat as well as to ensure that the sponsor does not purport the results to be unbelievably beneficial to the targeted patient population.

Emphasis should also be laid on novel and practical-oriented training programs for students in the health care profession to expose them to real-world situations. Students should understand the importance of having risk assessment, risk management, and risk mitigation plans in place to improve patient safety. Periodic assessment and continuing medical education programs for medical professionals are also pivotal in ensuring that they remain competent in their respective fields and prioritize patient safety and moral ethics in their profession.
The successful implementation of patient safety and data integrity is a multidisciplinary approach that requires sincere and diligent effort of each individual and organization involved in the conduct of clinical trials.

Disclaimer:

The information contained on this article is intended solely to provide general guidance on matters of interest for the personal use of the reader, who accepts full responsibility for its use. Accordingly, the information on this article is provided with the understanding that the author(s) and publisher(s) are not herein engaged in rendering professional advice or services. As such, it should not be used as a substitute for consultation with a competent adviser. Before making any decision or taking any action, the reader should always consult a professional adviser relating to the relevant article posting.

While every attempt has been made to ensure that the information contained on this article has been obtained from reliable sources, Veeda Clinical Research is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information on this article is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. In no event will Veeda Clinical Research, or its partners, employees or agents, be liable to the reader or anyone else for any decision made or action taken in reliance on the information on this article or for any consequential, special or similar damages, even if advised of the possibility of such damages. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, electronic, photocopying, recording or otherwise without the prior written permission of the publisher.


For information, contact us at:

Veeda Clinical Research Private Limited
Vedant Complex, Beside YMCA Club, S. G. Highway,
Vejalpur, Ahmedabad – 380 051,
Gujarat India.
Phone: +91-79-3001-3000
Fax: +91-79-3001-3010
Email: info@veedacr.com

Current outlook of Clinical Research in India

India is rapidly gaining acceptance globally as the go-to destination for clinical research. The country offers the advantages of having experienced personnel, good infrastructure such as well-equipped hospitals and laboratories, and a diverse patient pool. Moreover, the increase in life expectancy rate to 65 years and above gives rise to a host of lifestyle diseases such as diabetes, hypertension, neurodegenerative diseases and more, paving way for many multinational pharmaceutical companies to invest in clinical trials in India. Apart from this, cost effectiveness is an important factor that drives outsourcing of clinical trials to India.

The recent amendment made by the Ministry of Health and Family Welfare, Government of India, to the regulatory laws (New Drugs and Clinical Trials Rules, 2019) was with the aim of increasing the percentage of clinical trials conducted in India that hit an all-time low in the period between 2011 and 2013. In a bid to streamline approval processes, well-defined timelines have been introduced. The new rules have shortened the approval timeline for clinical trials of drugs manufactured outside India to 90 days. For drugs manufactured in India, the clinical approval timeline is 30 days. Pre-submission and post-submission meetings between the sponsor and the Drugs Controller General of India (DCGI) are attempts to increase transparency in all dealings related to the clinical trial. In addition, the non-refundability clause of the compensation package was removed as this was seen as a major deterrent for international companies, especially if a death/injury was proved to be unrelated to the trial at later stages. Apart from clinical trials, there has been a boom in the field of data management and medical writing with a number of homegrown clinical research organizations (CROs) demonstrating expertise to handle end-to-end services for sponsor companies.

Last but not the least, concerted efforts and joint participation of the Indian government and Indian pharmaceutical companies in policy-making decisions and prioritization of patient’s safety and health will build confidence in international companies about India’s capability in contributing to the clinical research industry.

Shaping of a regulatory framework specific to the Indian clinical market

As India emerges as one of the leaders in production of generic pharmaceuticals, contributing to approximately 20% of the global market1, it is necessary to have regulatory authorities approve of more number of drugs or clinical trials to address the burden of diseases prevalent in India. However, to safeguard public health, it is equally important to ensure that national and international pharmaceutical companies comply with stringent regulatory processes laid down for approval of drugs.

Changes in the Indian regulatory scenario

Revision of Schedule Y of the Drugs and Cosmetics act, 1945 in 2005 helped in aligning the Indian regulatory framework with internationally accepted definitions and procedures. In addition, the Indian Good Clinical Practices (GCP) guidelines that were drafted by the expert committee of the Central Drugs Standard Control Organization (CDSCO) helped in ensuring uniformity in the conduct and quality of clinical research across the country. With the recent introduction of the New Drugs and Clinical Trial Rules by the Ministry of Health and Family Welfare of India in 2019, the government is focusing on fast tracking the approval of new drugs with equal weightage given to bio-equivalence or bioavailability studies.2 The government has also ensured further strengthening of the regulatory sector by allocating a higher budget of approximately 65 million US dollars at the central and state level. This has helped in improving the infrastructure such as setting up of an E-governance portal (SUGHAM) to bring in transparency, accountability, and ease of business. A good initiative by the CDSCO was the setting up of a pharmacovigilance program in 2010 to have robust systems in place for adverse event reporting.1

The new regulatory rules

Some of the regulatory rules that have become effective following the New Drugs and Clinical Trials Rules 2019 are:

  • •Timelines have been revised for approval of global clinical trial applications to 90 days and 30 days for domestic trials from the previous duration of 6 months.3
  • •Phase III clinical trials are not required for any new drugs that has been approved for sale in United States, Canada, Australia or the United Kingdom.3
  • •Post-marketing surveillance studies are to be conducted in India to monitor for idiosyncrasies or unexpected adverse events.3
  • •Orphan drugs have been exempted from phase III and phase IV clinical trials.3
  • •Participant has access to free drug post trial if no suitable alternative is available in the market. However, the Sponsor would not be responsible for any complications that occur post the study duration.4
  • •The approval obtained for a clinical trial is valid for 2 years.4
  • •Compensation for death/injury/disability that is related to the trial will be decided by the Drug Controller General of India (DCGI).4

 Conclusion

To head towards India’s goal of becoming a competent clinical trial destination, it is important to not only speed up the approval of drugs or clinical trials but also to keep allegiance to the Ethics committee and to the Indian Council of Medical Research’s (ICMR) National Ethical Guidelines for Biomedical and Health research involving Human Participants, to prevent exploitation of trial participants.Transparency in the drug approval process and stringent laws with penalties for unethical conduct of trials can become game changers with respect to maintaining high standards of quality for drugs and reliability of data from clinical trials. The regulatory environment can also see an improvement in implementation of regulatory laws by increasing the number of skilled staff such as drug inspectors, regulatory specialists and so on. Equal emphasis should be laid on standard operating procedures (SOPs) and updating guidance documents to help staff understand the current regulatory environment. Exchange programs with other countries that have sound regulatory processes can be beneficial for the Indian regulatory personnel to appreciate the importance of a well-defined regulatory framework and how some aspects can be practically implemented in the Indian regulatory environment.6

Of utmost priority should be a patient’s safety and rights. Having a representative from patient advocacy groups in important decision-making meetings held by the DCGI allows for a patient-centric approach with respect to review of policies and laws.6

To conclude, high quality drugs and ethical clinical trials are the joint responsibility of sponsors, clinical investigators, and regulatory bodies. Periodically updating the Indian regulations can address loopholes and instill confidence in international pharmaceutical companies to continue investing in India. This will in turn propel India’s economic growth.

Sources

  1. 1.Medicines regulation. Regulatory systems in India. WHO Drug Information. 2017;31(3). https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_31-3_RegSystemIndia.pdf?ua=1
  2. 2.Ramu B, Kumar M S, and Ramakrishna N. Current Regulatory Scenario for Conducting Clinical Trials in India. Pharmaceutical Regulatory Affairs. Open Access. 2015;4:2. https://www.researchgate.net/publication/281765214_Current_Regulatory_Scenario_for_Conducting_Clinical_Trials_in_India
  3. 3.Vaidyanathan G. India’s clinical-trial rules to speed up drug approvals. Nature. April 2019. https://www.nature.com/articles/d41586-019-01054-4. Accessed on June 11, 2019.
  4. 4.https://www.turacoz.com/2019/04/15/new-drug-and-clinical-trial-rules-2019-india-what-they-bring-to-the-table/ Accessed on June 11, 2019.
  5. 5.Jesani A and Srinivasan S. New Drugs and Clinical Trials Rules, 2019: The market trumps ethics and participant rights. Indian Journal of Medical Ethics. 2019. https://doi.org/10.20529/IJME.2019.020. https://ijme.in/articles/new-drugs-and-clinical-trials-rules-2019-the-market-trumps-ethics-and-participant-rights/?galley=print
  6. 6.Naik K. Clinical Trials in India: History, Current Regulations, and Future Considerations. 2017. https://www.emich.edu/chhs/hs/documents/clra_final_projects/clinical_trials_in_india_history_current_regulations_and_future_considerations.pdf


Disclaimer:

The information contained on this article is intended solely to provide general guidance on matters of interest for the personal use of the reader, who accepts full responsibility for its use. Accordingly, the information on this article is provided with the understanding that the author(s) and publisher(s) are not herein engaged in rendering professional advice or services. As such, it should not be used as a substitute for consultation with a competent adviser. Before making any decision or taking any action, the reader should always consult a professional adviser relating to the relevant article posting.

While every attempt has been made to ensure that the information contained on this article has been obtained from reliable sources, Veeda Clinical Research is not responsible for any errors or omissions, or for the results obtained from the use of this information. All information on this article is provided “as is”, with no guarantee of completeness, accuracy, timeliness or of the results obtained from the use of this information, and without warranty of any kind, express or implied, including, but not limited to warranties of performance, merchantability and fitness for a particular purpose. Nothing herein shall to any extent substitute for the independent investigations and the sound technical and business judgment of the reader. In no event will Veeda Clinical Research, or its partners, employees or agents, be liable to the reader or anyone else for any decision made or action taken in reliance on the information on this article or for any consequential, special or similar damages, even if advised of the possibility of such damages. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, electronic, photocopying, recording or otherwise without the prior written permission of the publisher.

For information, contact us at:

Veeda Clinical Research Private Limited

Vedant Complex, Beside YMCA Club, S. G. Highway,

Vejalpur, Ahmedabad – 380 051,

Gujarat India.

Phone: +91-79-3001-3000

Fax: +91-79-3001-3010

Email: info@veedacr.com