DCGI permission is required for a new drug study

In case a product is in market for more than 4-year and client wants to do an intervention study. Is a DCGI approval/notification required?

New drugs as defined under Rule 122-E of Drugs and Cosmetics Rules include:

• Unapproved drugs,
• Modified or new claims e.g.
• New indications,
• New dosage forms (including sustained release dosage form) and
• New route of administration of already approved drugs and
• Combination of two or more drugs.

It depends on the indication/formulation. If the trial is 1) for a new indication or 2) for a new formulation/dose/route, the drug is considered a new drug. In such a case, DCGI permission is needed.

If the trial is not for a new indication and 4-year have elapsed since the drug was approved by DCGI office, the trial can be conducted with EC approval from an EC registered with CDSCO.

Principal investigator of one of the healthcare firms wants EC approval for his proposal to be carried out in a hospital which has EC. Only co-investigator who is responsible for the study belongs to this hospital. Can EC of this hospital give approval to this healthcare firm?

The EC has to consider how a principal investigator (PI) not attached to the hospital would fulfill his/her regulatory/GCP responsibilities towards the study subjects/ regulatory requirements. This would include several critical roles - consent, protocol compliance, source documentation, SAE reporting, etc. How will the PI sign the consent form, if he/she is not attached to the hospital? Also, how will the PI manage audits/inspections? Similarly what role co-investigator will play? If he/she were to carry out all the roles of PI, then he/she should become the PI. Who will sign contract with the sponsor? How will the contract provide insurance for the trial?

The EC should ask all questions related to the investigator responsibility to the PI. Also, EC should have an SOP for reviewing/approval of PI, who is not attached to the institute.

Considering issues involved, the EC should be extremely cautious in reviewing/ approving such a study proposal.

If an independent private practitioner who wishes to do an observational cross sectional study that involves assessment of patient's present treatment, certain anthropometric and biochemical parameters like lipid profile among his patients visiting the clinic, will such study that does not involve any drug use require ethical clearance?. If yes, from where can a private practitioner obtain such clearance if not affiliated to any institution/ organization in India?

As per ICMR 2006 guidance, an investigator cannot decide that her/his protocol falls in the exempted category without approval from the IEC. All proposals will be scrutinized by EC to decide under which of the categories - exemption, expedited or full review - it will be considered:

Full review by EC
Proposals which have 1) Collection of blood samples by finger prick, heel prick, ear prick, or venipuncture iv. prospective collection of biological specimens for research purposes by noninvasive means, 2) Collection of data through noninvasive procedures routinely employed in clinical practice, 3) Research involving clinical materials (data, documents, records, or specimens) that will be collected solely for non-research (clinical) purposes, 4) Collection of data from voice, video, digital, or image recordings made for research purposes.

Your study includes estimation of biochemical parameters. Hence, as per the ICMR guidance, your study will need EC approval. As your study does not involve any intervention, drug, you can approach unregistered or registered ECs for review of your protocol. The list of registered ECs is available on CDSCO website (www.cdsco.nic.in

Legally, which kinds of studies can unregistered EC review? Do such committees hold any importance?

The unregistered ECs can approve studies which are not part of any regulatory submission to CDSCO. The unregistered ECs do not comply with requirements of Rule 122 DD rules for registration of EC.