5. Investigator and Investigational Product

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?  

No, the PI must be a suitably qualified physician. There are no requirements for approval other than what is required by good clinical practice documents.

5.2 Does local regulation require any specific documents if PI/CI is based outside the country?

No. There are no further regulations or specific documents if PI/CI is based out of the country.

5.3 Does local authority allow electronic ICF administration, including electronic signatures?

ICF may also be administered and documented electronically, as long as the information recorded is the same as what would be recorded on a hard copy.

5.4 Does local regulation require ICF to be administered as audio/visual and do these need to be recorded?

Investigator(s) must obtain an audio-video (AV) recording of the informed consent process for vulnerable participants in clinical trials of a new chemical entity or new molecular entity, including the procedure of providing information to the participant and his/her understanding of the consent.

https://clinregs.niaid.nih.gov/country/india#documentation_requirements

5.5 Is there any specific information/requirement on data capture/management (e.g., privacy regulations, etc.)?

Data protection in India is currently regulated by the Information Technology Act.

Per the Act, the sponsor or any other person on its behalf, responsible for collecting, receiving, possessing, storing, dealing with, or handling provider information must provide a privacy policy for the handling of or dealing with this personal information including sensitive personal data or information. The IT Rules define sensitive personal data or information as information relating to password(s); financial information; physical, physiological, and mental health condition(s); sexual orientation; medical records and history; and biometric information. The sponsor must ensure that this policy is available for viewing by the information providers under a lawful contract. The policy must be published on the sponsor’s or its representative’s website and provide the following:

• Clear and easily accessible statements of its practices and policies
• The type of personal information including sensitive personal data or information collected
• The purpose of collection and usage of such information
• Disclosure of information including sensitive personal data or information
• Reasonable security practices and procedures

https://clinregs.niaid.nih.gov/country/india#personal_data_protection

5.6 If a clinical study involves the study product as OTC and this is provided via pharmacy/amazon, etc., are there any specific regulations for IP management that need to be followed?

There is no specific guidance on this subject.

5.7 For a marketed study product/OTC, can a participant be compensated after confirmation of the purchased study product, or upfront prior to product acquisition? Does compensation in any way impact how the study is viewed (i.e., RWE vs. Interventional Study)? 

There is no specific guidance on this subject.

5.8 Is it permitted to pay participant stipends (i.e., is it permitted to pay the patients for their participation in the clinical trial)? If so, what is the average range? 

Yes; there is an expectation that patients will be reimbursed for incidental expenses depending on the study. The amount of payment is generally very low (< USD100).

https://clinregs.niaid.nih.gov/country/india#required_elements

5.9 Specific labeling requirements for clinical study product

The labeling of any new drug or investigational new drug product manufactured or imported for the purpose of conducting a clinical trial or for testing and analysis should include the following items:

1. The drug name or code number
2. Batch number or lot number
3. Manufacture date
4. Use before date
5. Storage conditions
6. Name of institution/organization/center where the clinical trial or testing and analysis is proposed to be conducted
7. Manufacturer name and address
8. The purpose for which the investigational product is being imported

https://clinregs.niaid.nih.gov/country/india#labeling

5.10 What documents need to be submitted (including relevant fee if any), and to whom, if a permit is needed for an investigational/study product being shipped from outside the country? Are there any specific requirements for biologics? 

The DCGI is responsible for authorizing the import of IPs in India. The DCGI approves the import of IPs as part of the clinical trial application review and approval process.

The sponsor is required to obtain a license from the DCGI to import an IP (new drug or investigational new drug) for clinical trial purposes. Per the Clinical Trial Rules, the sponsor must also ensure that the imported IPs are manufactured in accordance with Good Manufacturing Practices (GMPs) as laid down in the Drugs and Cosmetics Act and Rules.

The DCGI will grant an import license within 90 working days of receipt of the application. Once approved, the import license must remain valid for three (3) years from the date of issue, unless suspended or canceled. In exceptional circumstances, the DCGI may extend the license for an additional year. A checklist of manufacturing and import-related forms to be included in a global clinical trial application submission is available.

The sponsor must submit a fee of 5,000 Indian National Rupees (INRs) per product with an application for permission to manufacture or import the IP to be used in a clinical trial.

The DCGI will relax, abbreviate, omit, or defer clinical and non-clinical data requirements to import or manufacture new drugs already approved in other countries on a case-by-case basis for life-threatening or serious/rare diseases and drugs intended to treat diseases of special relevance to the Indian population, unmet medical needs in India, and in disaster or special defense use (e.g., hemostatic and quick wound healing, enhancing oxygen carrying capacity, radiation safety, or drugs to combat chemical, nuclear, or biological conditions). This decision will vary depending on the specific clinical trial phase proposed and the clinical parameters related to the study drug.

5.11 What is the turn-around time to get an import permit?

DCGI will grant an import license within 90 working days of receipt of the application. Once approved, the import license must remain valid for three (3) years from the date of issue, unless suspended or canceled.

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDI2MQ==

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDM0MA==

5.12 Does local authority allow the destruction of clinical supplies at an off-site location (e.g. third-party vendor in or outside the country) after study completion? Are certificates of destruction required? 

Yes. There is nothing to prevent disposal from taking place at an alternative location. In the event that a new drug or investigational new drug manufactured for a clinical trial or testing and analysis purposes is left over, remains unused, incurs damage, has an expired shelf-life date, or has been found to be of sub-standard quality, the drug must be destroyed and the action taken should be recorded.

There is no specific requirement for a certificate of destruction.   

https://clinregs.niaid.nih.gov/country/india#product_management