Drugs & Therapeutics Committee (DTC)

1. PREAMBLE

This Constitution establishes the Drugs and Therapeutics Committee (DTC) at Netaji Subhas Medical College and Hospital in compliance with the National Medical Commission Act, 2019, the Minimum Standard Requirements for Medical Colleges, and the directions issued by the Post-Graduate Medical Education Board (PGMEB) of NMC vide Public Notice No. N-P016 (11)2/2023-PGMEB-NMC dated 11.12.2025.

The Committee is constituted to ensure rational, safe, effective, and cost-efficient use of medicines within the institution and to maintain the highest standards of pharmaceutical care and prescription practices.

2. NAME AND JURISDICTION

The Committee shall be known as the "Drugs and Therapeutics Committee (DTC)" of Netaji Subhas Medical College and Hospital, Amhara, Bihta, Bihar.

Its jurisdiction shall extend to all matters relating to drug selection, procurement, prescription practices, adverse drug reaction monitoring, and therapeutic decision-making within the institution.

3. COMPOSITION OF THE COMMITTEE

The Drugs and Therapeutics Committee shall comprise the following members:

Table 1: Composition of Drugs and Therapeutics Committee

Special Invitees: The Committee may invite subject experts, clinical specialists, or administrative officers as special invitees for specific agenda items requiring their expertise.

4. TENURE AND APPOINTMENT

1. The Committee, once constituted, shall have a tenure of two (2) years from the date of notification.
2. The Chairperson may nominate alternate representatives in case of unavailability of any member.
3. Upon completion of the tenure, the Committee shall be reconstituted by the Principal/Dean with such changes as deemed appropriate.

5. OBJECTIVES OF THE COMMITTEE

The primary objectives of the Drugs and Therapeutics Committee are:

1. To develop, maintain, and regularly update the Hospital Formulary/Essential Medicines List for the institution.
2. To ensure that only safe, efficacious, cost-effective, and quality medicines are used in the hospital.
3. To develop and implement Standard Treatment Guidelines (STGs) and Treatment Protocols for common diseases.
4. To promote rational prescribing practices and generic drug usage as mandated by NMC regulations.
5. To monitor and evaluate prescription patterns and ensure compliance with regulatory and ethical standards.
6. To oversee the procurement, storage, and distribution of drugs in accordance with quality standards.
7. To establish and monitor the Adverse Drug Reaction (ADR) reporting and Pharmacovigilance system.
8. To ensure legibility and clarity in prescription writing as mandated by NMC and judicial directives.
9. To conduct Drug Utilization Evaluation (DUE) and Drug Utilization Review (DUR) studies.
10. To educate and train medical staff, students, and healthcare professionals on rational drug use.

6. FUNCTIONS AND RESPONSIBILITIES

The Drugs and Therapeutics Committee shall discharge the following functions:

6.1 Formulary Management

1. Prepare, review, and update the Hospital Drug Formulary at least annually.
2. Evaluate and approve applications for addition or deletion of drugs from the formulary.
3. Ensure inclusion of generic medicines and compliance with the National List of Essential Medicines (NLEM).
4. Establish criteria for formulary inclusion based on therapeutic efficacy, safety, cost-effectiveness, and evidence-based medicine.

6.2 Standard Treatment Guidelines

1. Develop and periodically revise Standard Treatment Guidelines (STGs) for common conditions.
2. Ensure adherence to STGs across all clinical departments.
3. Develop antibiotic policy and facility-based antibiogram to guide rational antibiotic use.

6.3 Prescription Monitoring and Compliance

1. Monitor prescription practices to ensure compliance with NMC regulations requiring generic prescribing and legible handwriting.
2. Ensure prescriptions are written legibly, preferably in capital letters, in accordance with the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
3. Review electronic health records and manual prescriptions for clarity and completeness.
4. Identify prescription errors and recommend corrective and preventive measures.

6.4 Drug Utilization Studies

1. Conduct periodic Drug Utilization Evaluation (DUE) studies to assess prescribing patterns.
2. Monitor consumption patterns of high-risk drugs, antibiotics, controlled substances, and expensive medications.
3. Use Defined Daily Dose (DDD) methodology for analysis.
4. Provide feedback to prescribers and departments based on findings.

6.5 Adverse Drug Reaction Monitoring

1. Establish and maintain a robust ADR reporting and monitoring system.
2. Ensure reporting of ADRs to the National Pharmacovigilance Programme.
3. Investigate serious adverse events and implement preventive measures.
4. Create awareness about ADR reporting among healthcare professionals.

6.6 Educational and Training Activities

1. Organize Continuing Medical Education (CME) programs, workshops, and seminars on rational drug use.
2. Conduct training sessions for faculty, resident doctors, and students on prescription writing, formulary compliance, and pharmacovigilance.
3. Prepare and disseminate drug information bulletins and therapeutic updates.

6.7 Quality Assurance

1. Monitor the quality of drugs procured and used in the hospital.
2. Ensure compliance with Good Pharmacy Practice (GPP) guidelines.
3. Review medication errors and implement corrective measures.
4. Coordinate with the hospital administration on drug procurement and inventory management.

7. SUB-COMMITTEE FOR PRESCRIPTION MONITORING

In compliance with NMC Public Notice dated 11.12.2025, a dedicated Sub-Committee for Prescription Monitoring shall be established under the Drugs and Therapeutics Committee with the following mandate:

7.1 Composition of Sub-Committee

Table 2: Prescription Monitoring Sub-Committee

7.2 Functions of Sub-Committee

The Sub-Committee shall:

1. Develop a structured plan for systematic appraisal of prescriptions to assess compliance with NMC regulations and guidelines.
2. Review and analyze prescription patterns regularly, identify deviations from standards, and recommend corrective measures.
3. Ensure that all prescriptions are written legibly, preferably in capital letters, with generic drug names.
4. Verify compliance with the mandate that "every physician should prescribe drugs with generic names legibly."
5. Monitor adherence to rational prescribing practices and formulary compliance.
6. Ensure that findings of each appraisal are recorded in the minutes of DTC meetings.
7. Make records available to the National Medical Commission whenever called for.
8. Ensure timely implementation of all recommended measures to enhance compliance.

8. MEETINGS

1. The Committee shall meet at least once every quarter (four times annually) or more frequently as required.
2. The Sub-Committee for Prescription Monitoring shall meet at least once every two months (six times annually).
3. The Member Secretary shall convene meetings in consultation with the Chairperson and issue at least seven days' notice along with the agenda.
4. The quorum for meetings shall be fifty percent of the total members plus one.
5. Minutes of each meeting shall be recorded by the Member Secretary and circulated to all members within fifteen days.
6. Decisions shall be taken by consensus or, if necessary, by majority vote.
7. Emergency meetings may be convened with shorter notice in case of urgent matters.

9. POWERS AND AUTHORITY

The Drugs and Therapeutics Committee shall have the following powers:

1. To recommend policies related to drug procurement, storage, and distribution.
2. To approve or reject proposals for addition or deletion of drugs from the hospital formulary.
3. To issue directives on prescription practices and therapeutic protocols to be followed by all prescribers.
4. To review and recommend disciplinary action in cases of serious prescription errors or non-compliance.
5. To seek information, data, and reports from all departments and administrative units related to drug use.
6. To constitute sub-committees and working groups for specific tasks.

10. REPORTING AND DOCUMENTATION

1. The Committee shall maintain comprehensive records of all meetings, decisions, and actions taken.
2. An annual report summarizing the Committee's activities, achievements, and recommendations shall be submitted to the Principal/Dean and Management.
3. All records, minutes, and reports shall be made available to the National Medical Commission or any regulatory authority upon request.
4. The Committee shall maintain registers for:
   • Hospital Drug Formulary
   • Adverse Drug Reactions
   • Prescription Monitoring Records
   • Drug Utilization Studies
   • Meeting Minutes

11. COORDINATION WITH OTHER COMMITTEES

The DTC shall coordinate and collaborate with:

1. Infection Control Committee for antibiotic stewardship and hospital-acquired infection prevention.
2. Hospital Management Committee for budget and procurement matters.
3. Medical Education Committee for curriculum integration and teaching activities.
4. Ethics Committee for ethical aspects of drug research and usage.
5. Medical Records Committee for documentation standards.

12. AMENDMENTS

This Constitution may be amended from time to time by a resolution passed by two-thirds majority of the Committee members present, subject to approval by the Principal/Dean and compliance with NMC regulations.

13. COMPLIANCE AND ENFORCEMENT

1. Compliance with the decisions and directives of the DTC shall be mandatory for all faculty, resident doctors, and healthcare staff.
2. The Principal/Dean shall ensure necessary administrative support and resources for effective functioning of the Committee.
3. Non-compliance with DTC directives may attract appropriate administrative or disciplinary action as per institutional policies.

14. DISSOLUTION

The Committee shall continue to function unless dissolved or reconstituted by the Principal/Dean in consultation with the Management, subject to maintaining compliance with NMC requirements.

Adopted by:

FOR AND ON BEHALF OF THE INSTITUTION:

Dr. __________________ [Name & Signature]
Principal/Director
Netaji Subhas Medical College & Hospital
Date: _______________
Seal:

Prof. _________________ [Name & Signature]
Chairperson, Governing Body
Date: _______________

APPROVED AND NOTIFIED BY:

Sitwanto Devi Mahila Kalyan Sansthan
Secretary: _________________ [Name & Signature]
Date: _______________

ANNEXURE: STATUTORY AND REGULATORY REFERENCES

This Constitution is framed in compliance with:

1. National Medical Commission Act, 2019 (Act 30 of 2019)
2. National Medical Commission (Minimum Standard Requirements for Annual MBBS Admissions) Regulations, 2020
3. National Medical Commission (Establishment of New Medical Institutions, Starting of New Medical Courses, Increase of Seats for Existing Courses & Assessment & Rating) Regulations, 2023 (as amended in 2026)
4. Public Notice No. N-P016 (11)2/2023-PGMEB-NMC dated 11.12.2025 on Establishment of Sub-Committee under DTC for Monitoring of Prescription Practices
5. Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
6. Clinical Establishments (Registration and Regulation) Act, 2010
7. Order dated 27.08.2025 of the Hon'ble High Court of Punjab and Haryana in Yogesh vs. State of Haryana (CRM-M-30305-2024)
8. WHO Guidelines on Drug and Therapeutics Committees
9. National List of Essential Medicines (NLEM), Government of India