3 weeks ago
Pharma upgrade drive faces delays; 18% units receive incentives
The Indian government has a special program to help small medicine-making factories buy better equipment and make safer medicines.
The program is called the Revamped Pharmaceutical Technology Upgradation Assistance Scheme, or RPTUAS.
Under this program, the government promised financial help to 301 medicine factories.
But by March this year, only 55 factories, a little more than 18 out of every 100, had actually received the money.
The reason is that factories must first follow new, tougher safety rules called Schedule M. Many small factories are finding it hard to meet these stricter rules quickly.
The government gives the money only after a factory finishes its upgrades and inspectors check the work.
Some factories are upgrading in stages so they can keep making medicines while improving their processes.
A group of parliament members has asked the government's medicine department to help the remaining factories finish faster.
There are about 10,500 medicine factories in the country, and most of them are small.
Just over 18% of the 301 pharma units approved for incentives under the government's RPTUAS technology-upgradation scheme had received them by March this year.
The government approved incentives worth Rs 300.5 crore, and 55 units have so far received Rs 41.7 crore.
Claims from 64 units worth Rs 45.8 crore were approved, while 237 approved units remain at various stages of implementation.
The scheme supports MSME units upgrading to revised Schedule M and WHO-GMP standards, but compliance among MSMEs is estimated below 50%.
A parliamentary panel has asked the Department of Pharmaceuticals to provide facilitation and handholding for the remaining 237 approved units.
- Who
- Indian pharmaceutical manufacturers, mainly MSME units, the Department of Pharmaceuticals, and a parliamentary panel.
- What
- Only just over 18% of the 301 pharma units approved for incentives under the RPTUAS technology-upgradation scheme had received them by March, as manufacturers face delays in meeting revised Schedule M norms.
- Where
- India, based on a report presented in Parliament.
- When
- By March this year; Schedule M norms were first notified in December 2023, and the deadline for smaller manufacturers was extended to December 2025.
- Why
- The government releases assistance only after upgrades are completed and verified by drug regulatory authorities, and smaller companies are upgrading in phases to avoid disrupting production.
Regulatory push for quality
Burden on small manufacturers
Revised Schedule M compliance
Regulatory push for quality
Tougher manufacturing norms under revised Schedule M are necessary to ensure drug quality and meet WHO-GMP standards.
Burden on small manufacturers
The stricter norms are hard for smaller manufacturers to meet on time, causing delays and forcing phased upgrades that disrupt progress.
Pace of incentive disbursement
Regulatory push for quality
Incentives are released only after upgrades are completed and verified by drug regulatory authorities, ensuring proper use of public funds.
Burden on small manufacturers
The slow disbursal leaves just 18% of approved units funded, and a parliamentary panel has asked for facilitation and handholding for the remaining 237 units.
Key facts
- Scheme
- Revamped Pharmaceutical Technology Upgradation Assistance Scheme (RPTUAS)
- Incentives approved
- Rs 300.5 crore for 301 pharma units
- Units that received incentives
- 55 units received Rs 41.7 crore
- Claims approved
- 64 units worth Rs 45.8 crore
- Units still implementing projects
- 152
- Total pharma manufacturing units
- Around 10,500, with about 8,500 in the MSME category
- Schedule M norms notified
- December 2023
- Smaller manufacturers' compliance deadline
- Extended to December 2025
Sources
Related news
Parliament Panel Urges Deadline For Medicine Trade Margin Caps
Centre Invites Applications for ₹5,000 Crore Pharma Innovation Scheme
India Launches Rs 62,500-Crore Mobile Production Scheme for Brands
Criteria Changes Delay Scooty-Laptop Aid for Madhya Pradesh Students
Rajasthan Suspends 215 Private Pharmacies Over RGHS Medicine Delays
USFDA Warns Dabur India Over Manufacturing Lapses at Silvassa Plant
New Hangout Sitcoms Turn Friendship FOMO Into Streaming Appeal
Chinese Workers Fight Office Ageing With Parasols And Sunscreen
India Sends Fifth Relief Tranche to Flood-Hit Nepal
Dyson Launches $499 CameraJet AI Toothbrush With Jet Flossing
PlatinumRx remotely helps families save on recurring medicines
