Norms for Strengthening Pharma Industry

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Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers recently released guidelines for Strengthening of Pharmaceutical Industry (SPI) scheme to address the rising demands for the support required by the existing Pharma clusters and MSMEs across India. This would improve their productivity, quality, and sustainability. For the period from fiscal FY 21 - 22 to FY 22 - 26, an outlay of ₹ 500 crore has been assigned by the Centre.

Pharma Industry Stricter Norms


  • Financial assistance to be provided to the pharma clusters for creating Common Facilities which in turn would not only improve the quality but also ensure sustainability growth of the clusters.
  • Interest subvention or capital subsidy on the capital loans would be provided for upgrading the production facilities of SMEs and MSMEs to meet national and international regulatory standards (WHO-GMP or Schedule-M) and this is likely to further facilitate the growth in terms of volumes and in quantity.

Three Components/Sub-Schemes


  • Assistance to Pharmaceutical Industry for Common Facilities.
  • Strengthening the existing pharmaceutical clusters՚ capacity for their sustained growth by creating common facilities.


  • Pharmaceutical Technology Upgradation Assistance Scheme.
  • This would facilitate Micro, Small, and Medium Pharma Enterprises (MSMEs) to meet national and international regulatory standards.


  • Pharmaceutical & Medical Devices Promotion and Development Scheme.
  • This would facilitate growth and development of Pharmaceutical and Medical Devices Sectors.
  • Use of study/survey reports, awareness programs, creation of database and promotion of industry.

API-CF Sub-Scheme

Support to clusters for creating common facilities with focus on R&D labs, Testing Laboratories, Effluent Treatment Plants, Logistics Centres and Training Centres w. r. t order of priority and outlay of ₹ 178 crore for the scheme period of five years.

PTUAS Sub-Scheme

  • Proposed support for SME Industries either through up to a maximum of 5 % per annum of interest subvention or through Credit linked Capital subsidy of 10 % .
  • The loan supported is to a limit of 10 crores.
  • The eligible components of the loan have been listed in the guidelines of the scheme.
  • For the scheme period of five years, an outlay of ₹ 300 crore has been earmarked for the sub-scheme.

PMPDS Sub-Scheme

  • The knowledge and awareness about the Pharmaceutical and MedTech Industry would be promoted.
  • Undertaking studies, building databases, and bringing industry leaders, academia, and policymakers together for sharing their knowledge and experience.
  • For the scheme period of five years, an outlay of ₹ 2.15 crore has been earmarked for the sub-scheme.

Units Supported

Under this scheme, the units supported are expected to act as Demonstration Firms for the Pharma clusters and MSE Pharma Industries which in turn would develop quality and technology up-gradation fronts.

Industry Scenario

  • Indian Pharmaceuticals industry plays a prominent role in the global pharmaceuticals industry.
  • By volume and production India ranks 14th and 3rd worldwide respectively.
  • India is also the largest producer of generic medicines globally.
  • The pharmaceutical industry is further expected to each $ 65 billion by 2024 and to $ 120 billion by 2030.
  • India accounts for nearly 60 % of the global vaccine demand.
  • In 2013 - 14, Indian pharma exports witnessed a growth of 103 % .

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