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As per CDSCO regulation BA/BE data required for new drugs


Wednesday, July 05, 2017, 08:00 Hrs  [IST]

A medical device company outside India, intends to conduct a clinical trial for a new medical device in India. Please guide me if the sponsor wants to conduct the clinical trial in India for their device, then, the device must be first registered in India?

Shalini Dayananda

In 2017, the CDSCO has issued G.S.R. 78(E) - Rules for Medical Devices. As per the Gazette, the following rules would be relevant to consider regarding clinical investigation of a medical device.

The sponsor can import the device for clinical investigation, without any prior registration.

(l) “clinical investigation” means the systematic study of an investigational medical device in or on human participants to assess its safety, performance, or effectiveness;

40. Test licence for import for test, evaluation, clinical investigations, etc. - (1) Notwithstanding anything contained in these rules, any medical device or in vitro diagnostic medical device may be imported for the purpose of clinical investigations or test or evaluation or demonstration or training.

(2) The person who desires to import medical device under sub-rule (1), shall apply for an import licence for test, evaluation or demonstration or training to the Central Licensing Authority in Form MD-16, accompanied by such fee as specified in the Second Schedule.

51. Application for grant of permission to conduct clinical investigation. - (1) An application for grant of permission to conduct clinical investigation for investigational medical device shall be made to the Central Licensing Authority in Form MD-22 by a sponsor and shall be accompanied with information specified in the Seventh Schedule.

63. Permission to import or manufacture medical device which does not have its predicate device. - (1) Save as otherwise provided in these rules, for import or manufacture of medical device which does not have predicate medical device, an application for grant of permission for such medical device after completion of its clinical investigation under Chapter VII shall be made to the Central Licensing Authority in Form MD-26 either by an authorised agent in case of import or a manufacturer, as the case may be, which shall be accompanied with fee as specified in the Second Schedule along with information specified in Part IV of the Fourth Schedule

Seventh schedule requirements for permission to import or manufacture investigational medical device for conducting clinical investigation as per tables listed

  • Design analysis data
  • Biocompatibility and animal performance study
  • The agreement between the sponsor and principal and coordinating investigator(s).
  • Appropriate insurance certificate, if any.
  • Forms for reporting any adverse event and serious adverse event.
  • Report of biocompatibility tests along with rationale for selecting these tests including a summary report and
  • Conclusion of the study.
  • Results of the risk analysis.
  • Animal performance study data
  • Clinical investigational plan, Investigator’s brochure, Case report form informed
  • Consent form, investigator’s undertaking, and Ethics Committee clearance.
  • Pilot and pivotal clinical investigation data including that, if any, carried out in other countries.
  • Regulatory status and restriction on use in other countries, if any, where marketed or approved.
  • Proposed instructions for use and labels.
Are CMEs compulsory for doctors working in BA/BE study especially if they are not practicing and working only in BA/BE?
Nitin

Indian GCP has following requirement for investigator qualifications.

3.3.1. Qualifications
The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI). The investigator should provide a copy of the curriculum vitae and/or other relevant documents requested by the sponsor, the ethics committee, the CRO or the regulatory authorities.

The doctor should register with state medical council to be able to perform the duties of a medical practitioner. The doctors working in BA/BE perform roles of the clinical investigator and a medical practitioner e.g. screening volunteers, managing adverse events. So, they should have the qualifications as per MCI. However, unless the doctor has fulfilled conditions of registration with state council, which require mandatory completion of CME hours, the doctor cannot perform roles of the clinical investigator and a medical practitioner. Hence, it is essential for the doctors in BA/BE study to attend CMEs and obtain registration from state council.

The MCI registration would be an essential document during sponsor audits and regulatory inspection. If the doctor in BA/BE setting does not have this evidence, the auditor/inspector would make this a major/critical finding. In case a volunteer/ subject suffers from complications of a serious adverse event, and makes an allegation about incompetence of the doctor, absence of registration with state council would be a legal issue.

Is it necessary to submit the BA/BE data for the product, which is being marketed for last more than 4 years?
Anup Pal

As per CDSCO regulations, BA/BE data are required for new drugs. The definition of new drugs includes – new molecular/chemical entity, new indication, new formulation, new fixed dose combination etc. If the drug is already marketed for more than 4 years after its approval by CDSCO, then it is not a new drug. Hence, there is no CDSCO requirement of submission of BA/BE data.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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