Effective 2nd August 2016, the Central Drugs Standard Control Organization (CDSCO) India released new circulars in relation to the conduct of clinical trials. These new circulars have modified the trial requirements for sponsors wishing to conduct clinical trials in India. Furthermore, the CDSCO have addressed matters that may assist in reducing clinical trial timelines and encourage further investigator participation.

These changes are as follows:

Requirement of No Objection Certificate (NOC) from DCGI (Drug Controller General India) for addition of new Clinical Trial site or investigator

It was decided that the respective ethics committee, after due diligence, can approve proposals for addition of site(s) and investigator(s) and that a NOC from DCGI should not be necessary. However, the applicant would need to inform the DCGI regarding any addition/deletion of sites and investigators. Subsequently, if no objection was received from the DCGI, it would be considered admissible by the CDSCO.

Restriction of conducting three clinical trials per investigator

The impact on sponsors being unable to utilise sites/PIs (principal investigator) with specific patient populations (as a result of earlier restrictions) has now been addressed as a result of this circular. Prior to this no investigator could conduct more than three trials at any time. Once an ethics committee examines the risk and complexity involved in the proposed trial(s), they will then decide how many trials an investigator is permitted to undertake.

Requirement of 50 bedded site for clinical trials

Previously it was determined that no clinical trial shall be conducted at sites with less than 50 hospital beds. This position has been revised and it has now been established that an ethics committee will examine the trial requirements and decide whether the intended clinical trial site is suitable (or not), irrespective of the number of beds. Additionally, it was noted that sites will need to have appropriate emergency rescue and care services, along with all other necessary facilities required for a particular trial.

Requirement of approval of Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs

Going forward, the applicant may submit parallel applications to the RCGM and DCGI seeking approval to conduct a clinical trial involving r-DNA derived drugs. DCGI will complete the review of the application and issue permission, only after RCGM clearance is received.

With these new requirements in place, processes such as assigning new sites/investigators to a study; facilitating the conduct of out-patient based studies at small hospitals/clinics that have larger patient pools; allowing motivated, research-focused investigators to undertake more trials at appropriate sites and, potentially reducing clinical trial approval timelines for rDNA based products, will help to streamline clinical trial set up and ongoing operations for sponsors.

Partnering with a CRO that has experienced, regulatory professionals both central and in-country can provide efficiencies when conducting trial in countries with unfamiliar or shifting regulations. George Clinical’s regulatory team possess a wealth of experience, region knowledge and contacts needed to communicate effectively with the appropriate, in-country regulatory agencies – such as DCGI and CDSCO. This allows us to anticipate and resolve any potential issues or hurdles that may arise throughout your trial. As such, we can provide the relevant advice and strategies tailored to your individual needs, based on the most current regional guidelines, as part of the global regulatory context. With these qualities, we are able to provide customizable trial excellence from trial design through all aspects of delivery.

Key Points:

• New regulations will help streamline trial requirements for new/current clinical trials in India.
• George Clinical’s regulatory team will analyse potential impact of any regulatory changes and provide expert advice on applicability and integration; ensuring your regulatory requirements are met.
• Recommended that sponsors partner with experienced CROs with in-depth knowledge of India’s regulatory environment.

Contact Details

George Clinical Regulatory Compliance
T: +61 (2) 8052 4300
E: [email protected]

For more information on these circulars or the CDSCO, please visit: http://www.cdsco.nic.in/forms/list.aspx?lid=1604&Id=31

For more information on George Clinical and our services, please visit:
https://www.georgeclinical.com/