Environmental Clearance

Regulations Governing Environment Clearance for Bulk Drugs and Intermediates Industries

calendar30 Mar, 2023
timeReading Time: 4 Minutes
Regulations Governing Environment Clearance for Bulk Drugs and Intermediates Industries

Bulk drug intermediate industries produce the raw materials or intermediates used to produce bulk drugs or Active Pharmaceutical Ingredient (APIs). These industries play a crucial role in the pharmaceutical supply chain by providing raw materials to manufacture finished drug products. They also allow manufacturers to optimize their production processes by outsourcing intermediate production, reducing costs and improving efficiency. Environment Clearance for bulk drugs is subject to strict regulations and quality standards to ensure the safety and efficacy of the final drug products. The industry constantly evolves as new drugs and treatments are developed, creating new opportunities for intermediate manufacturers to innovate and expand their product offerings.

Type of Bulk Drug Intermediate Industries

The bulk drug intermediate industry is segmented based on the intermediate and end user type.

Type of Intermediate:

  • API Intermediate: These are the raw materials or drugs responsible for the therapeutic action of the final drug product.
  • Advanced Intermediate: These are advanced forms of drug intermediates used for drug interaction activity to form new chemical products.

End User:

  • Pharmaceutical Industry: This includes drug manufacturers and pharmaceutical companies that use the intermediates to manufacture finished drug products.
  • Biotechnology Industry: This includes biotech companies that use intermediates to develop biologics and biosimilars.
  • Chemical Industry: This includes chemical companies that produce intermediates for use in the pharmaceutical and biotechnology industries and for other applications such as cosmetics and fragrances.

Importance of Environment Clearance for Bulk Drugs and Intermediate Industries

The importance of Environmental Clearance for bulk drugs and intermediate industries are as follows:

  • Helps in Environmental Impact Assessment (EIA) Study: To get environmental clearance for bulk drugs and intermediate industries they are required to conduct a comprehensive EIA study. The study should identify potential environmental impacts and provide recommendations for mitigating or minimizing those impacts.
  • Ensures Submission of Application to SEIAA or MoEF: Once the EIA study is completed, the industry must apply to the State Environment Impact Assessment Authority (SEIAA) or the Ministry of Environment and Forests (MoEF)[1] for obtaining environmental clearance.
  • Ensures Compliance With Environmental Regulations: To obtain environmental clearance, the industry must comply with all relevant environmental regulations and standards, including those related to air and water pollution, solid and hazardous waste management, noise pollution, and biodiversity conservation. The industry must demonstrate that it has taken all necessary measures to prevent or mitigate environmental impacts and ensure sustainable development.

Environmental Aspects for Bulk Drugs Manufacturing Process

The environmental aspects that are typically associated with the bulk drug and intermediate industry:

  • Effluent: The industry generates wastewater during various stages of the production process. The effluent contains organic and inorganic compounds, heavy metals, and other contaminants that can harm the environment and human health if not treated properly.
  • Emission: The industry also emits various gases during the production process, such as nitrogen oxides, sulfur dioxide, and carbon monoxide. These emissions can contribute to air pollution and adversely affect the local environment and public health.
  • Fugitive emission: Fugitive emissions refer to releasing gases or vapors from equipment or processes that are not intentionally vented to the atmosphere. This can occur due to leaks or other malfunctions, and can lead to the release of harmful chemicals into the environment.
  • Noise Pollution Aspect: The industry can generate high noise levels due to equipment operation and other activities. This can lead to noise pollution and have adverse effects on nearby communities and wildlife.
  • Solid Wastes: The production process generates solid waste, such as packaging materials, containers, and other non-hazardous materials. Improper disposal of these wastes can lead to environmental pollution and health risks.
  • Hazardous Wastes: The industry also generates hazardous waste, such as chemical by products and waste materials that cannot be reused or recycled. These wastes can pose significant risks to human health and the environment if improperly handled and disposed of.

Regulations Governing Environment Clearance for Bulk Drugs and Intermediate Industries

The regulatory framework for obtaining Environmental Clearance (EC) for bulk drug and intermediate industries in India is governed by the Ministry of Environment, Forest and Climate Change (MOEFCC) and the State-level Environment Impact Assessment Authorities (SEIAA).

The process for obtaining Environment Clearance for bulk drugs involves the following steps:

  • Submission of An Application: The industry seeking EC has to submit an application to the concerned SEIAA along with necessary documents and fees.
  • Screening: The SEIAA conducts a screening of the application to ensure it is complete and all relevant information is provided.
  • Scoping: If the application is complete, the SEIAA identifies the proposed project’s potential impacts and specifies the terms of reference (ToR) for preparing an Environmental Impact Assessment (EIA) report.
  • Preparation of EIA Report: The industry has to prepare an EIA report based on the ToR provided by the SEIAA. The EIA report should include an assessment of the project’s potential environmental impacts, measures to mitigate these impacts, and a plan for monitoring and reporting environmental performance.
  • Public Consultation: The EIA report is made available to the public for comments and feedback. A public hearing is also conducted to gather feedback from the local community.
  • Appraisal: The SEIAA appraises the EIA report, public comments, and feedback received during the public hearing, and prepares a report with its recommendations.
  • Decision-Making: Based on the SEIAA’s report, the MOEFCC decides on whether to grant or deny EC. If EC is granted, it is subject to conditions that the industry must comply with.


Environment Clearance for bulk drugs and intermediate industries asks for operation in an environmentally sustainable manner. The SEIAA and MOEF have laid down various regulations and guidelines to ensure the industries comply with environmental norms and standards. The industries need to assess the environmental impact of their activities and take necessary measures to mitigate any adverse effects. Strict monitoring and enforcement of regulations are also required to ensure compliance. By following these regulations and adopting cleaner production practices, the bulk drug and intermediate industries can ensure sustainable growth while safeguarding the environment and public health.

Also Read:
Environmental Clearance Process In India: A Complete Outlook

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