The sponsor of a trial is responsible for providing the trial supplies, which includes the Investigational Product (IP), comparator(s), placebo(s), as applicable. It is essential that the drug supplies are manufactured in accordance to the principles of Good Manufacturing Practice (GMP), and packaged in a manner that protects the product from any deterioration or damage. The labelling should safeguard the blinding of the trial (if applicable). The manner of labelling should be in accordance to the New Drugs and Clinical Trial Rules, 2019.

The information on the label must include the following (but are not limited to):

• The words: “For Clinical Studies Only” (in bold format)
• Name of the IP or code number
• Batch or Lot Number
• Name of the trial or Protocol Number or Protocol Identifier
• Participant code / Participant identification number
• Name and contact number of the investigator
• Name and address of the site/institution where the trial is to be conducted
• Date of manufacture and use before date
• Storage conditions
• Name and address of the manufacturer

The sponsor should determine the following:

• Reconstitution procedure (if applicable)
• Devices for product administration (if any).

The manner of labelling for a medical device for the purpose of test, evaluation, clinical investigation, etc. should be in accordance to the Medical Devices Rules, 2017 [G.S.R. 78(E)] The labels of the containers for medical devices must indicate the following information:

• Name of the product or code number
• Batch or lot number
• Serial number (wherever applicable)
• Date of manufacture
• Use before date
• Storage conditions
• Name and address of the manufacturer
• Purpose for which it has been manufactured

The above should be communicated to all concerned parties, in writing, and also be stated on the product label (wherever possible). The trial supplies should not be made available at the site, until all required approvals have been received (ethics approval and/or permission from the regulatory agency or any other local bodies). Once the draft labels have been approved by CDSCO, no changes in the label and/or package insert shall be effected without an approval from the regulatory authority (CDSCO).

Drug supplies shall be provided to sites along with documented procedures for the following:

• IP description and packaging (including all ingredients and formulation, and any placebos used in the trial)
• The precise dosing
• Method of packaging, labelling, and blinding of drug supplies
• Method of assigning treatments to the participants
• Participant identification code numbering system
• Adequate and safe receipt, handling, storage, and dispensing the product
• Retrieval of unused product from the trial participants
• Return of unused product to the sponsor (or its alternative disposal procedure).

Records of the following must be maintained by the sponsor, for the following:

• Investigators Brochure (IB) and its amendments (if any), or SmPC (Summary of Product Characteristics),or Package Insert for marketed drugs
• Certificates of Analysis (COA)
• Quantities of IP used /procured for the study, with their batch numbers: It is important that the sponsor retains sufficient samples from each batch, that has been provided to the sites. Records of IP accountability logs should also be maintained at the trial level, site level and participant level.
• Quantity of IP supplied at each site.
• Dispensing of IP: The IP should be dispensed as per the randomization schedule (if applicable). During the trial, if the IP has not been handled and/or dispensed according the relevant SOPs, it should be recorded and reported as per the sponsor’s requirements. Each time the IP is dispensed to a participant, it should be appropriately recorded, and respective logs are filed in the Investigator Site File (ISF).
• Retrieval or destruction of the product after completion of the trial.
• Retrieval / Destruction SOPs and certificate (as applicable).
• Retrieval of quarantined /expired product (whenever applicable)

During site close-out, it must be ensured that the IP accountability logs and forms are complete, and copies are retrieved for the Trial Master File (TMF). In addition to this, all unused trial supplies must be reconciled and returned to the sponsor or destroyed (in accordance to the sponsor’s requirements and applicable regulatory guidelines). In case the IP is destroyed at the site, it is important to ensure that the relevant Destruction SOP is followed, and the Certificate is obtained from the Head of the Institution.

References

• New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 03.04.2019).
• Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
• Medical Devices Rules, 2017, [ G.S.R. 78(E)], Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online (last accessed on 12.03.2019).
• ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9^th November 2016, available online (last accessed on 26.02.2019).
• Clinical Development Services Agency SOP for Monitoring the Management of Investigational Product, version 1.0.