About: Bulk drugs or APIs

What is a bulk drug park and why Himachal wants one

In News

  • Himachal Pradesh (HP) is one of the states trying to get an allotment of a bulk drug park under the central government bulk drug park scheme.
  • The HP government has identified around 1,400 acres in Una district and sent a proposal to the Centre.
  • Several other states including Andhra Pradesh, Maharashtra, Gujarat, Haryana, Punjab, Tamil Nadu and Telangana have expressed interest in the scheme, and are likely to send their respective proposals.

About: Bulk drugs or APIs

  • A bulk drug, also called an active pharmaceutical ingredient (API), is the key ingredient of a drug or medicine, which produces the required therapeutic effects in the body.
  • For example, paracetamol is a bulk drug, which acts against pain. It is mixed with binding agents or solvents to prepare the finished pharmaceutical product, i.e. a paracetamol tablet, capsule or syrup, which is consumed by the patient.

Key Starting Material and Drug Intermediates:

  • APIs are prepared from multiple reactions involving chemicals and solvents.
  • The primary chemical or the basic raw material which undergoes reactions to form an API is called the Key Starting Material (KSM).
  • Chemical compounds formed during the intermediate stages during these reactions are called Drug Intermediates (DIs).

Reasons for launching the Bulk Drug Parks

  • India has one of the largest pharmaceutical industries in the world (third largest by volume) but this industry depends on other countries, particularly China, for importing APIs, DIs and KSMs.
  • This year, operations of drug manufacturers in India have suffered due to disruption in imports.
  • In January, factories in China were shut down when China went into a lockdown, and later, international supply chains were affected due to the Covid-19 pandemic.
  • The border conflict between India and China, further worsened the situation.
  • All these factors pushed the Indian government to announce a scheme for the promotion of bulk drug parks in the country.

Scheme for Promotion of Bulk Drug Parks

Objective of the scheme:

  • The objective of the scheme is to set up bulk drug parks in the country to reduce the manufacturing cost of bulk drugs and make India self-reliant in bulk drugs.
  • To help industry meet the standards of environment at a reduced cost through innovative methods of common waste management system.

Details of the scheme:

  • Under the scheme, a one-time grant-in-aid will be provided for creation of common infrastructure facilities in selected Bulk Drug Park proposed by a State Government.
  • A bulk drug park will have a contiguous (continuous) area of land with common infrastructure facilities for the exclusive manufacture of APIs, DIs or KSMs, and also a common waste management system.
  • Three bulk drug parks will be supported under the scheme, with the total financial outlay of Rs. 3000 Crore. Maximum grant-in-aid for one bulk drug park will be limited to Rs 1000 crore.
  • The grant-in-aid will be 70 per cent of the cost of the common facilities but in the case of Himachal Pradesh and other hill states, it will be 90 per cent.
  • The duration of the Scheme is from FY 2020-2021 to FY 2024-2025.

Selection process of the bulk drug parks:

  • A state can only propose one site, which is not less than a thousand acres in area, or not less than 700 acres in the case of hill states.
  • The proposals should contain the estimated cost, feasibility studies, environmental risk assessment etc.
  • A project management agency, nominated by the department of pharmaceuticals, will examine these proposals and make recommendations to a scheme steering committee, which will then approve the proposals.

News Summary:

  • Himachal Pradesh (HP) is one of the states trying to get an allotment of a bulk drug park under a central government scheme announced earlier this year, for the promotion of bulk drug parks.
  • The HP government has identified around 1,400 acres in Una district and sent a proposal to the Centre.
  • Several other states including Andhra Pradesh, Maharashtra, Gujarat, Haryana, Punjab, Tamil Nadu and Telangana have expressed interest in the scheme, and are likely to send their respective proposals.

Advantages in Himachal Pradesh

  • According to the Himachal Pradesh government, the state already has Asia’s largest pharmaceutical manufacturing hub, (the Baddi-Barotiwala-Nalagarh industrial belt) and the state produces around half of India’s total drugs.
  • Power and water tariffs in the state are very low and the state also has an industrial gas pipeline.

Economics

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