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DCGI approval not required for clinical trial of herbal products
Dr Arun Bhatt | Wednesday, January 31, 2018, 08:00 Hrs  [IST]

We are the guidelines for computer systems for clinical trials?

Dr Shivani Vyas

ICH E6 R2 Addendum provides guidance on computerized systems.

ICH E6 R2 5.5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:

(a) Ensure and document that the electronic data processing system(s) conforms to the sponsor’s established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e., validation).

Glossary 1.65 validation of computerized systems
A process of establishing and documenting that the specified requirements of a computerized system can be consistently fulfilled from design until decommissioning of the system or transition to a new system. The approach to validation should be based on a risk assessment that takes into consideration the intended use of the system and the potential of the system to affect human subject protection and reliability of trial results.

The sponsor should maintain SOPs for using these systems, which should cover system set up, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning.

The responsibilities of the sponsor, investigator, and other parties with respect to the use of these computerized systems should be clear, and the users should be provided with training in their use.

Can we store clinical trial data publicly shared locations such as google drive?
Jitendra Sharma

As per US FDA, it is the responsibility of the sponsor or CRO to assess if they cloud storage system it intends to use is secure enough for storing clinical trial data. When cloud computing services are used to store data for regulatory clinical trials, you should consider whether there are adequate controls in place to ensure the reliability and confidentiality of the data. You should determine if there have been any past security data breaches with the public cloud storage computing services and, if so, that appropriate corrections have taken place. You should consider the regulatory requirements for computerized systems use in clinical trials e.g. ICH E6 R2, FDA Guidance Computerized Systems Used in Clinical Investigations. If the outsourced electronic service does not provide the data security safeguards described in the regulatory guidance, you should consider the risks of using such service e.g., patient privacy rights, reliability of the data in the clinical investigation and its regulatory implications. You should also perform appropriate risk assessments considering issues such as data access, integrity, and security, to ensure that data residing on storage devices outside their country can be retrieved and accessed during FDA inspections.

What is the Indian regulatory situation re: herbal research?
Riddhi Shukla

In Indian regulations, the major class of herbal products are:

a) Classical Ayurveda drugs as mentioned in the authoritative books of Ayurveda system, which are manufactured and named in accordance with the formulations described in the authoritative texts.

b) Patent or Proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation or invention to manufacture products different from the classical medicine.

None of these classes of herbal medicines come under purview of DCGI as they do not fall into categories of new drugs as per Indian regulations. (Definition given below) Hence, DCGI approval is not required for clinical trial of herbal products.

Drugs & Cosmetic Rules 2016
122E. Definition of new drug - for the purpose of this part, new drug shall mean and include:
(a) A drug, as defined in the Act including bulk drug substance [or phytopharmaceutical drug] which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:

(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.

(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of Appendix VI to Schedule Y.)

For the purpose of this rule -

(i) All vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21.

(ii) A new drug shall continue to be considered as new drug for a period of four years from the date of its first approval.

In 2015 regulatory requirements Central Drugs Standards Control Organization (CDSCO) prescribed regulatory provisions for phytopharmaceuticals. Phytopharmaceutical drug is defined as purified and standardised fraction with defined minimum four bio-active or Phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route. Clinical trials of phytopharmaceutical drug would require DCGI approval.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries

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