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Introduction: Manufacturing Active Pharmaceutical Ingredients in India

Introduction: Manufacturing Active Pharmaceutical Ingredients in India

The Indian pharmaceutical industry is the 3rd largest in the world by volume and valued at $50 bn. It has high market presence in several advanced economies such as the US and EU. The country contributes 3.5% of total drugs and medicines exported globally to over 200+ countries.

 The industry is well known for its production of affordable medicines, particularly in the generics space. However, the country is significantly dependent on the import of basic raw materials, viz., Bulk Drugs that are used to produce medicines. In some specific bulk drugs, the import dependence is 80 to 100%.

To ensure greater resilience to external shocks, enforce greater drug security and boost the capacity for domestic production for critical bulk drugs and high-value products alike, the Department of Pharmaceuticals has launched 3 supporting schemes to incentivize the global and domestic players to enhance investment and production in these product categories.

The Schemes are envisioned to ensure greater resilience of the Indian pharmaceutical industry to external shocks and contribute significantly to achieving a higher objective of affordable healthcare in the country and globally on a sustained basis.

Key starting materials/Drug intermediates/Active Pharmaceutical Ingredients are the Raw material, for example- acetaminophen contained in a pain relief tablet and  Penicillin G benzathine injection is used to treat bacterial infections

Under the scheme, financial incentive is proposed for manufacturing of 41 eligible products under the four Target Segments .

  • Fermentation based KSMs/Drug Intermediates.
  • Fermentation based niche KSMs/Drug Intermediates /APIs.
  • Key Chemical Synthesis based KSMs/Drug Intermediates.
  • Other Chemical Synthesis based KSMs/Drug Intermediates/APIs

Incentives for incremental sales will be given to selected participants for a period of 6 years. The total outlay of the scheme is Rs. 6,940 crore and the scheme is under implementation after receiving good response from the participants.

National Industrial Classification (NIC) for pharmaceutical clusters –

The National Classification Code (NIC Code) is a statistical standard for developing and maintaining a comparable data base for various economic activities. It has been developed to ascertain and analyse how each economic activity contributes towards national wealth. For Manufacture of pharmaceuticals, medicinal chemical and botanical products Division 21, Group 210. Manufacture of pharmaceuticals, medicinal chemical and botanical products excludes:

  •  manufacture of herb infusions (mint, vervain, chamomile etc.), (1079)
  • wholesale of pharmaceuticals, (4649)
  • retail sale of pharmaceuticals,( 4772)
  • packaging of pharmaceuticals,( 8292 )
  • manufacture of dental fillings and dental cement, (3250)
  • research and development for pharmaceuticals and biotech pharmaceuticals, (7210 21001)

 Note- This no. is given above like 1079,4772, 3250 are group , class and sub-class of particular description.

Manufacture of medicinal substances used in the manufacture of pharmaceuticals: antibiotics, endocrine products, basic vitamins; opium derivatives; sulpha drugs; serums and plasmas; salicylic acid, its salts and esters; glycosides and vegetable alkaloids; chemically pure suger etc.

Manufacturing States

There are various states majorly (Maharashtra, Gujarat, Tamil Nadu) for different types of productions and services like:

  • Captive R&D Units
  • Contract R&D Units
  • Established Bulk Drug Cluster
  • Established Formulation Cluster
  • Emerging Bulk Drug Cluster
  • Emerging Formulation Cluster

Raw Materials for the production of Drug Ingredients and Active Pharmaceutical Ingredients

Infrastructure Required

Company is having all the required infrastructure to manufacture the products as per WHO cGMP requirement and complies to EU GMP norms. The company has a built up area of about 120,000 sq. feet for production and storage of its products spread over 6000 sq. meters of Area. 

The infrastructure includes dedicated HAVC systems with environment control (temp and humidity) at individual production steps and auxiliary areas. Complete water management system with loop, separate storage and supply management system for each categories of drugs.

Services including compressed air, refrigeration, electricity generation, purified water plant, distillation plant, ETP plants and boiler for steam generation are provided in the engineering block.

Kaushal Sharma

Kaushal Sharma is a Research Intern at Tatvita-Analysts. He is pursuing Masters in Economics from Symbiosis College.

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