The Central Pollution Control Board (CPCB) on January 16, 2025, issued Draft Guidelines for the Pharmaceutical Industry in India.
The key highlights are as stated:
• Classification of the Pharmaceutical Industry:
The pharmaceutical industries are mainly classified as pharmaceutical (formulation), vaccine manufacturing, Ayurvedic or Unani Medicine, and pharmaceutical R&D.
Further, the Pharmaceutical Industries has been sub-categorized as (i) Pharmaceuticals manufacturing; (ii) Pharmaceutical R & D, (iii) Pharmaceuticals (Formulation) and (iv) Vaccine manufacturing and based on the cleaner fuel as (i) Pharmaceuticals manufacturing using Cleaner/gaseous fuel, (ii) Pharmaceuticals (Formulation) using Cleaner/gaseous fuel and (iii) Vaccine manufacturing using cleaner/gaseous fuel.
• Manufacturing Process
Bulk pharmaceutical substances typically consist of structurally complex organic chemical compounds which are manufactured via a series of intermediate steps and reactions under precise conditions. These substances are used in the manufacture of the dosage form of a formulated pharmaceutical product and are manufactured by one of the following processes:
o Chemical Synthesis
o Fermentation process
o Natural/Biological Extraction
o Formulations
• Management of Waste water
Wastewater streams in pharmaceuticals and biotechnology manufacturing depend on the specific process and may include: chemical reactions streams; product wash water; spent acid and caustic streams; condensed steam from strippers; air pollution control scrubber blow downs; equipment and facility wash water; and floor wash water. The main conventional pollutants of concern in these wastewater streams from primary manufacturing (e.g. fermentation, chemical synthesis, and biological / natural extraction) are biochemical oxygen demand (BOD), chemical oxygen demand (COD), total suspended solids (TSS), ammonia, TDS, heavy metals, toxicity, biodegradability, and pH.
• Management of Air Emission
Air emissions from the pharma industries could be either from point sources or diffused in nature. Usually, the point sources are provided with control equipment, thus emissions from these sources are corresponding to their efficiency of control system. Industry should take up on priority, the control of hazardous air pollutants (such as benzene, carbon tetrachloride, 1-4 dioxin, methanol, toluene, methyl chloride etc.) and odorous compounds (mercapatan & hydrogen sulphide).
• Management of Hazardous waste
Chemical and Biological sludge or any residue, reject, concentrate generated from wastewater treatment or its management facility at Industry or Common Effluent Treatment Plants (CETP) catering to industries engaged in manufacturing of bulk drug formulations of pharmaceuticals, has been classified as Hazardous Waste as per the provisions of the Hazardous Waste and Other Wastes (Management and Transboundary Movement) Rules, 2016 and shall be managed in environmentally sound manner in accordance with these rules.
All the Stakeholders/Public are required to submit their comments/suggestion within by February 05, 2025, to the following e-mail address: [email protected] (Sh. Dinabandhu Gouda, Scientist ‘F’, IPC-I Division) and [email protected] (Sh. Raj Narayan Pankaj, Scientist ‘E’, IPC-I Division, CPCB).
