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RPTUAS

Facts for Prelims (FFP)

 

Source: PIB

 Context: The Department of Pharmaceuticals under the Ministry of Chemicals and Fertilizers has announced the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme (RPTUAS).

 

What is RPTUAS?

Revamped Pharmaceuticals Technology Upgradation Assistance Scheme aims to enhance the quality and safety of pharmaceutical products manufactured in India. The scheme offers support to pharmaceutical manufacturing units for technology and quality upgradation.

PTUAS is a component of the Strengthening of Pharmaceutical Industry (SPI) Scheme. SPI Scheme aimed to strengthen the existing infrastructure facilities to make India a global leader in the Pharma Sector. RPTUAS is the successor of PTUAS under SPI.

 

Key features:

  1. Broadened Eligibility: Previously, the scheme only included MSME Pharma units, now the incentive is available to any pharmaceutical manufacturing units based on turnover criteria:
    1. Turnover less than Rs 50 crore: Incentive of 20% of investment under eligible activities.
    2. Turnover from Rs 50 crore to less than Rs 250 crore: Incentive of 15% of investment under eligible activities.
    3. Turnover from Rs 250 crore to less than Rs 500 crore: Incentive of 10% of investment under eligible activities.
  1. Flexible Financing: It offers flexible financing options, including subsidies on a reimbursement basis, to diversify financing options for participating units.
  2. Support for Compliance: Supports technological upgrades aligned with revised Schedule-M and WHO-GMP standards, covering various improvements such as HVAC systems, testing laboratories, and clean room facilities.
    1. Schedule-M of the Drugs and Cosmetics Rule, 1945 provides good manufacturing practices (GMP) for pharmaceutical products
  3. Dynamic Incentive Structure: Provides incentives based on the average turnover for the last three years, with a maximum incentive of Rs one crore per unit.
  4. Integration with State Schemes: Allows integration with state government schemes to provide additional assistance, fostering collaboration between central and state initiatives.
  5. Enhanced Verification: Introduces a robust verification mechanism through a Project Management Agency to ensure transparency, accountability, and efficient resource allocation.

 

Incidents of issues with Indian pharma products:

  1. Quality Control Concerns: E.g., Four types of medicine, made in India, caused the deaths of at least 70 children in Gambia in 2022
  2. Regulatory Violations: E.g., Sun Pharmaceutical Industries received a warning letter from the FDA for failing to comply with GMP regulations at its Halol plant.
  3. Drug Recalls: E.g., Dr Reddy’s Laboratories recalled over 3,342 bottles of hypertension drugs in the US due to the presence of impurities.
  4. Counterfeit Drugs: As per a report, fake drugs constituted over $4 billion of the total $14–17 billion of the Indian domestic drug market
  5. Export Bans: E.g., EU banned the import of over 700 generic drugs manufactured in India due to concerns about data integrity and manipulation.