Pharmacovigilance Committee

Preamble

As per the Guidelines of Medical Council of India, it is essential to constitute Pharmacovigilance Committee to oversee various Pharmacological aspects of Drug administration & subsequent patient compliance in a Teaching Hospital wherein Medical College is proposed to be established. Therefore, all below referred members have been
nominated in the Pharmacovigilance Committee of the Hospital against the post mentioned against their names.

Goal

The broad goal of the committee will be to generate awareness about the need of identifying & reporting of Adverse Drug Reactions (ADR), amongst all sections of health care providers (Doctors, Consultants, Nurses, Pharmacists, Post Graduate & Under Graduate Students, service providers etc.) of Parul Institute of Medical Sciences & Research & Parul Sevashram Hospital and to identify ADR occurring in patients admitted to Parul Sevashram Hospital &
report the same to the appropriate authorities.

Objectives

  • To create awareness amongst health care professionals about the importance of ADR reporting
  • To monitor benefit-risk profile of medicines
  • Generate independent, evidence based recommendations on the safety of medicines
  • Support the CDSCO for formulating safety related regulatory decisions for medicines
  • Communicate findings with all key stakeholders
  • Create a national centre of excellence at par with global drug safety monitoring standards

Constitution

Sr. No.NameDesignationPost at PVC
1Dr. V. P. HathilaDeanChairman
2Dr. Indira ParmarSuperintendentMember
3Dr. B. D. ParmarHOD, MedicineMember
4Dr. Dilip RavaliaHOD, SurgeryMember
5Dr. C. R. KakaniHOD, OBGYMember
6Dr. Anita PatelHOD, AnaesthesiaMember
7Dr. Ashruti KachaHOD, PaediatricsMember
8Dr. H. L. KubavatHOD, OrthopaedicsMember
9Dr. Devanshu PatelAssistant Professor, PharmacologyMember
10Dr. Geetika MadanAssistant Professor, PSMMember
11Dr. Ankit BhartiAssistant Professor, Skin & VDMember
12Ms. Smrutibala PatelNursing SuperintendentMember
13Ms. Hetal MehtaPharmacy InchargeMember
14Dr. D. C. SharmaHOD, PharmacologyMember Secretary

Tenure of the Committee

October 2015 to October, 2018
The committee shall be reconstituted every three years.

Scope of the Committee

The committee shall meet once in 03 months. The committee shall be responsible for planning, implementation and monitoring of various activities of the Pharmacovigilance Committee. They will work as mentors & facilitators.

Roles

  • Chairman: The Chairman will chair & conduct all meetings & will function as administrative head of the committee.
  • Member Secretary: The Member Secretary will play the pivotal role & shall undertake various activities of the Committee.
  • Members: Members will work as subject experts & will also do the mentoring of young faculty/ resident doctors/ students in the area of ADR.

General Guidelines

Following General guidelines have been framed for committee functioning:

  • Committees shall meet regularly in every quarter of the year and shall determine the next date of meeting at every meeting
  • Agenda of the meeting (as per their scope) shall be determined beforehand and shall be communicated to all members of the committee
  • Committees shall discuss, analyze, take a unanimous decision and communicate the decision for implementation to appropriate department /personnel
  • Chairperson and convener of the committee shall bear the responsibility of committee functioning
  • The Committee shall determine the protocols of functioning and all committee members shall abide by it.
  • If a detailed analysis of specific agenda under consideration is carried out a record of
    same shall be maintained separately and filed in committee file
  • It is advisable that a specific member of the committee shall be given the responsibility of maintaining all the records of committee functioning and communicate it to concerned personnel in the organization
  • Committee shall monitor the implementation of decision taken through physical
    monitoring/ assessments/ review etc.
  • Hospital and staff are obliged to follow the instructions
  • Committee shall review their functioning at appropriate intervals, as decided by Chairman, to assess their functioning