PM-STIAC Discusses Regulations of Medical Products

Context: 

The 24th meeting of PM-STIAC (The Prime Minister Science Technology and Innovation Advisory Council) discussed issues related to medical and health industries in India. 

• The meeting was convened by the Principal Scientific Advisor of Govt of India

PM-STIAC: Prime Minister Science Technology and Innovation Advisory Council

• About: Constituted in August 2018, PM-STIAC serves as an important council to assess the status of various science and technology-related matters, comprehend challenges, formulate interventions, develop a futuristic roadmap, and advise the Prime Minister accordingly.
• Presided by: Principal Advisor to the Govt of India

• Objectives of PM-STIAC:

  • Synergising collaborative science and technology; 
  • Enabling future preparedness; 
  • Formulating and coordinating S&T missions; 
  • Providing an enabling ecosystem for techno entrepreneurship; 
  • Driving innovation, and technology, developing innovation clusters, and fostering effective public-private linkages among other responsibilities.

• Missions and initiatives Being Shaped Under PM-STIAG: 

  • One health mission: Coordinating human, animal, and environmental health to prevent pandemics and control priority diseases.
  • National Quantum Mission: To develop quantum technologies for communication, computing, and sensing applications.
  • Artificial Intelligence: To develop and deploy AI technologies for applications in various sectors, such as healthcare, agriculture, and manufacturing.
  • Waste to Wealth: To convert waste into wealth by developing recycling and resource recovery technologies.
  • Deep Ocean Exploration: To explore the deep ocean and develop technologies for its sustainable utilization.

24th Meeting of PM-STIAC

• Aim: To provide recommendations for a robust regulatory ecosystem in the medical and health industry 
• Themes Discussed:
  • Approval process of Drugs and suggested changes
    • Focused on promoting innovation while manufacturing drugs.
    • Enabling regulatory systems that align with global practice
  • Vaccine regulation in India
    • To simplify the approval process for vaccine development.
    • To streamline all approval processes and channelise all ministries, agencies, and committees in an organised system.
  • Diagnostic and medical device ecosystem
    • Focussed on ways and means to build an ecosystem for medical devices in India.
  • Regulatory ecosystem for the animal health product
    • Focused on both, progress made and issues faced by industries producing animal health products.
  • Regulations of emerging therapies in India 
    • Discussed harnessing the potential of India to become a global leader in Cell and Gene Therapy (CGT).

Regulation of Medical Products

• The regulations for medical products in India are primarily governed by the Medical Devices Rules, 2017 (MDR 2017), amended in 2020.
• These rules are implemented by the Central Drugs Standard Control (CDSCO).

News Source: PIB and The Hindu

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