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Committee on Regulatory Mechanism

Dr. Ravi Doomra
This Committee is Headed by Dr. Ravi Doomra  

In the IRA Chamber of Ayurveda, the Regulatory Mechanism Committee acts as the governing “gatekeeper.” While the Education Committee focuses on training, the Regulatory Committee ensures that every Ayurvedic product, research project, and industrial process complies with national and international laws.

Its primary goal is to ensure Safety, Efficacy, and Quality (SEQ) to boost global trust in Ayurvedic medicines.

Key Roles of the Regulatory Mechanism Committee

  1. Implementation of GMP and Quality Standards

The committee ensures that manufacturers adhere to Good Manufacturing Practices (GMP) as per Schedule T of the Drugs and Cosmetics Act.

  • Standardization: Setting strict benchmarks for the identity, purity, and strength of raw materials and finished products.
  • Laboratory Compliance: Encouraging the use of NABL-accredited labs for testing heavy metals, pesticides, and microbial loads.
  1. Navigating the Legal Framework (ASU Drugs)

Ayurveda, Siddha, and Unani (ASU) drugs are governed by specific sections of the Drugs and Cosmetics Act, 1940. The committee helps stakeholders navigate:

  • Licensing Support: Streamlining the process for obtaining manufacturing licenses and product approvals from the Ministry of AYUSH.
  • Labeling Compliance: Ensuring that product claims, ingredients, and warnings are legally accurate to prevent “misbranded” or “adulterated” drug charges.
  1. Ethical Research & Clinical Trials

For the “Research” arm of the IRA Chamber, this committee oversees the ethical side of drug development.

  • Protocol Validation: Ensuring that clinical trials follow Good Clinical Practices (GCP) specifically tailored for traditional medicine.
  • Ethics Committee Liaison: Coordinating with Institutional Ethics Committees (IEC) to protect participants in Ayurvedic research studies.

Strategic Objectives

The committee’s work is designed to move Ayurveda from “alternative medicine” to a “validated global healthcare system.”

Objective

Action Taken by Committee

Pharmacovigilance

Monitoring and reporting any adverse drug reactions (ADRs) to ensure long-term public safety.

IPR & Patents

Protecting traditional knowledge from bio-piracy while helping innovators file for modern patents.

Global Export

Aligning Indian standards with international bodies like the WHO and FDA to ease the export of Ayurvedic products.