Archive · 23 Sep 2025
Pharma Association Warns of Shutdown Due to Rising Regulatory Burden
Imagine a lot of small companies making medicine are having trouble.
Rules keep changing and getting expensive, especially for testing.
The companies are worried they won't be able to keep up, and this could lead to medicine shortages.
The companies want the government to change the rules.
They want the government to simplify the rules.
Otherwise, they might have to close down, which could cause people to lose jobs and make it harder to get the medicines they need.
DMMA warns of widespread closures due to regulatory burdens and high costs.
Over 30 pharma associations submitted a representation to the Health Minister.
Bio-equivalence studies, Revised Schedule M, and export process are primary concerns.
MSMEs are struggling to comply with the rules.
The industry body is requesting immediate regulatory relief.
- Who
- DMMA and other pharma associations
- What
- Warning of potential nationwide strike and shutdown of pharmaceutical units.
- When
- The article was published on September 23, 2025.
- Where
- India, with a focus on Gujarat
- Why
- Due to rising regulatory burden and costs that threaten MSMEs.
Industry Concerns
Government Stance
Regulatory Burden
Industry Concerns
Excessive regulations are financially unviable for MSMEs and threaten their operations.
Government Stance
The government's stance is not mentioned in the articles.
Cost of Compliance
Industry Concerns
High costs of bio-equivalence studies and GMP upgrades pose a barrier to MSMEs.
Government Stance
The government's stance is not mentioned in the articles.
Export Process
Industry Concerns
Complex export NOC process is losing business to competitors.
Government Stance
The government's stance is not mentioned in the articles.
- Key Organizations
- DMMA, Pharma Entrepreneurs, Laghu Udyog Bharti
- Threat
- Nationwide strike & shutdown of pharma units
- Main Concerns
- Regulatory burden, costs, and circulars
- Revised Schedule M
- MSMEs request extended deadline to April 2027
- Gujarat Pharma Units
- Accounts for 1/3 of India's turnover & 28% exports