The Indian government is currently working on developing a digital platform to overhaul the country’s drug regulatory system. The Ministry of Health is considering creating uniform regulations for drug regulators across both central and state levels, as well as establishing a centralized database to enhance oversight of the production, sale, and distribution of pharmaceuticals. In this essay, we will discuss the need for a new system, the proposed system, its benefits, and challenges.

The Need for a New System
  • India’s current drug regulatory system is fragmented, with 38 regulators each having their own database.
  • Both central and state governments are involved in issuing manufacturing licenses and regulating the drug sector.
  • There have been incidents where children have died after consuming drugs manufactured by Indian pharmaceutical firms.
  • The World Health Organization (WHO) issued a medical product alert regarding four cough syrups produced and exported by Maiden Pharma, a company based in Haryana. It is believed that the consumption of these cough syrups may have caused the deaths of at least 70 children in The Gambia.
  • India lacks a consolidated public database that records the transgressions of each company licensed under the Drugs And Cosmetics Act.
  • Only three states in India (Gujarat, Maharashtra, and Kerala) make their laboratory results available in a consolidated database.
  • If a drug company violates regulations in one state, the information may not be shared with other regional or federal regulatory bodies, such as the Central Drugs Standard Control Organization (CDSCO).
  • There is a need to ensure that all manufacturing within the country, regardless of whether it is carried out by MSMEs or larger drug manufacturers based in India, conforms to Good Manufacturing Practices (GMP) in light of recent issues.
The Proposed System

The Ministry of Health and family welfare recently organized a two-day “Chintan Shivir”, with a focus on improving drug quality, regulation, and enforcement. The session helped to identify concerns of the pharma industry and other stakeholders and prepare a roadmap for a more efficient regulatory system.

India is working on a single window portal, which will serve as a unifying hub for all key players involved in the process, including regulators, manufacturers, distributors, state-run entities, and procurement agencies. The integration of various stakeholders such as Central Drug Laboratories, state drug controllers, manufacturers, and others will be achieved through the integration of the Sugam portal (existing IT portal of the Central Drugs Standard Control Organisation (CDSCO)) with the new portal.

Benefits

The proposed system will bring in a common set of standards and regulations for the whole nation. It will enable drug regulators throughout India to easily access information about the credentials of pharmaceutical companies and drugs. It will improve the regulatory system and ensure that all manufacturing taking place within the country conforms to GMP.

Challenges

This idea may face challenges due to India’s federal structure and the fact that healthcare is a state subject. For the idea to be successful, all stakeholders involved, including both the Central and state governments must willingly cooperate. Maintaining a central database could be difficult if states do not provide accurate data in a timely manner. Generating awareness and encouraging active participation from all states will take time and effort.

Why In News

The digital platform being developed by the Government of India aims to bring in a common set of standards and regulations for the whole nation. This platform will enable drug regulators throughout India to easily access information about the credentials of pharmaceutical companies and drugs.

MCQs on Drug Regulatory System in India

  1. What is the current status of India’s drug regulatory system?
    A. Fragmented
    B. Consolidated
    C. Efficient
    D. Centralized
    Correct Answer: A. Fragmented
    Explanation: India’s drug regulatory system is currently fragmented, consisting of 38 regulators, each with its own database.
  2. Which Indian states currently make their laboratory results available in a consolidated database?
    A. Gujarat, Maharashtra, and Kerala
    B. Tamil Nadu, Karnataka, and Andhra Pradesh
    C. Uttar Pradesh, Bihar, and West Bengal
    D. Rajasthan, Madhya Pradesh, and Chhattisgarh
    Correct Answer: A. Gujarat, Maharashtra, and Kerala
    Explanation: Currently, only three Indian states – Gujarat, Maharashtra, and Kerala – make their laboratory results available in a consolidated database.
  3. What is the purpose of the digital platform being developed by the Indian government?
    A. To consolidate India’s drug regulatory system
    B. To centralize India’s drug regulatory system
    C. To increase the number of drug regulators in India
    D. To abolish India’s drug regulatory system
    Correct Answer: A. To consolidate India’s drug regulatory system
    Explanation: The Indian government is currently developing a digital platform with the aim of overhauling the country’s drug regulatory system, which is currently fragmented and lacking a consolidated public database.

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