Strengthening Drug Regulatory System in India: A Comprehensive Analysis

The Central government has released over 80% of the funds earmarked for strengthening the drug regulatory system at both the Central and state levels.

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FDA State Food and Drugs Administration
FDA

Last Updated on September 7, 2024 by The Health Master

Drug Regulatory

The Indian government has made significant strides in bolstering its drug regulatory infrastructure, aiming to ensure the safety, efficacy, and quality of pharmaceutical products.

A key component of this initiative has been the allocation of substantial funds to strengthen drug testing laboratories and upgrade existing regulatory offices across the country.

Central Government’s Investment in Drug Regulatory

The Central government has released over 80% of the funds earmarked for strengthening the drug regulatory system at both the Central and state levels.

This investment underscores the government’s commitment to ensuring the safety and quality of drugs available to Indian citizens.

  • Total Allocation: Rs. 1,750 crore
    • Central drug regulatory structures: Rs. 900 crore
    • Strengthening of States’ Drug Regulatory System (SSDRS): Rs. 850 crore

SSDRS Scheme: Key Objectives

The Strengthening of States’ Drug Regulatory System (SSDRS) scheme aims to enhance the capabilities of state-level drug regulatory authorities.

The key objectives of the scheme include:

  • Upgradation of Drug Testing Laboratories: Provision of additional equipment and manpower to improve the efficiency and accuracy of drug testing.
  • Establishment of New Laboratories: Setting up of new laboratories for testing drugs, medical devices, and cosmetics, as well as mobile drug testing laboratories.
  • Human Resource Development: Creation of additional manpower for regulatory structures, including for emerging areas like stem cell, regenerative medicine, biologicals, and medical devices.
  • E-Governance and IT Integration: Implementation of organization-wide e-governance and online services to streamline regulatory processes.
  • Training and Capacity Building: Establishment of a training academy for regulatory and drug testing officials.

Benefits of Strengthening Drug Regulatory System

The enhanced drug regulatory system is expected to yield several benefits, including:

  • Improved Drug Quality: Ensuring the safety, efficacy, and quality of drugs and medical products manufactured in India.
  • Reduced Disease Burden: Mitigating the disease burden by providing access to high-quality medicines.
  • Boosted Pharmaceutical Exports: Increasing exports of pharmaceutical products from India to global markets.
  • Growth of Domestic Medical Devices Sector: Stimulating the growth of the domestic medical devices industry.

Government Initiatives to Enhance Drug Quality

In addition to the SSDRS scheme, the Central government has implemented several other initiatives to ensure the quality of pharmaceutical products:

  • Training Programs: Conducting training programs for Central Drugs Standard Control Organization (CDSCO) and State Drug Control Officials.
  • Schedule M Revisions: Amending the Drugs Rules to revise the Schedule M for Good Manufacturing Practices.
  • Bar Code Implementation: Implementing bar codes or Quick Response Codes on the primary packaging label of top 300 brands.

By investing in the drug regulatory system and implementing comprehensive measures, the Indian government is working towards ensuring the safety and efficacy of pharmaceutical products for its citizens while also promoting the growth of the domestic pharmaceutical industry.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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