National Institute of Pharmaceutical Education and Research (Amendment) Bill, 2021


    In News

    Recently,The Rajya Sabha passed the National Institute of Pharmaceutical Education and Research (Amendment) Bill, 2021.

    • It was cleared by the Lok Sabha on December 6.

    Objectives and need 

    • There is a need for more pharmaceutical education and research institutions of national importance in India to suffice the present demands and the emerging trends in the pharmaceutical and health care industry.
    • The requirement for skilled manpower is all time high for making India self-reliant in pharmaceuticals and moving from only manufacturing to innovations. 
      • The NIPER amendment will boost research and innovation at institutes.
    • The bill will help in establishing the pharmaceutical innovation ecosystem in the various pharmaceutical clusters of the country
    • this will help the country to become the pharma capital of the world. Job prospects for students will also be increasing and more trained and multi-skilled manpower will be required for research,

    About the bill

    •  The bill seeks to amend the National Institute of Pharmaceutical Education and Research Act, 1998.  
      • The 1998 Act established the National Institute of Pharmaceutical Education and Research, Punjab and declared it as an Institution of National Importance. 
        •  An Institution of National Importance refers to an autonomous institute established under an Act, with the power to hold examinations, grant degrees, diplomas and other academic distinctions or titles.  
          • These institutes of national importance receive funding from the central government.  

    Major Higlights  

    • New institutions of national importance: 
      • The Bill declares six additional National Institute of Pharmaceutical Education and Research as Institutions of National Importance.  These institutes are located in: (i) Ahmedabad, (ii) Hajipur, (iii) Hyderabad, (iv) Kolkata, (v) Guwahati, and (vi) Raebareli.
    • Establishment of the Council: 
      • The Bill provides for a Council to coordinate the activities among the institutes under the Bill to ensure the development of pharmaceutical education and research and maintenance of standards.  
      • Functions of the Council include: 
        • advising on matters related to course duration, and admission standards in the institutes
        • formulating policies for recruitment, conditions of service, and fees,
        • examining and approving development plans of the institutes, and
        • examining annual budget estimates of the institutes for recommendations to the central government for allocation of funds.
    • Board of Governors: The Act constituted a Board of Governors for control and management of the institute’s affairs.  
      • The Act specifies 23 members in the Board .
        • The Bill reduces the number of members in the Board of Governors for each institute to 12.  
        • The Board will be chaired by an eminent academician or professional.   

    Pharmaceutical industry in India

    • The Indian Pharmaceutical Industry has witnessed robust growth over the past few years.
    • Indian medicines are preferred worldwide, thereby rightly making the country the “Pharmacy of the World”.
    • Major Segments of Pharmaceutical Industry are Generic drugs, OTC Medicines and API/Bulk Drugs, Vaccines, Contract Research & Manufacturing, Biosimilars & Biologics.
    • Pharma sector currently contributes to around 1.72% of the country’s GDP
    •  The country now ranks 3rd worldwide by volume of production and 14th by value, thereby accounting for around 10% of the world’s production by volume and 1.5% by value. 
    • Indian exports are destined to more than 200 countries around the globe including highly regulated markets of the US, West Europe, Japan and Australia.
    • FDI policy : Up to 100%, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects. For Brownfield pharmaceuticals projects, FDI allowed is up to 74% through automatic route and beyond that through government approval. 
    • Government Initiatives
      • In June 2021, Finance Minister Ms Nirmala Sitharaman announced an additional outlay of Rs. 197,000 crore (the US $26,578.3 million) that will be utilised over five years for the pharmaceutical PLI scheme in 13 key sectors such as active pharmaceutical ingredients, drug intermediaries and key starting materials.
      • The Department of Pharmaceuticals initiated a PLI scheme to promote domestic manufacturing by setting up greenfield plants with minimum domestic value addition in four separate ‘Target Segments’ with a cumulative outlay of Rs. 6,940 crore (US$ 951.27 million) from FY21 to FY30 to achieve self-reliance and minimise import dependency in the country’s essential bulk drugs,