Himachal pharma industry in crisis amid new central drug regulator policies, 300 units on brink of closure

Himachal pharma industry in crisis amid new central drug regulator policies, 300 units on brink of closure

Baddi-Barotiwala-Nalagarh hit most, industrialists demand corrective measures

TNR News Network
SOLAN:
The pharmaceutical industry in Himachal Pradesh, once hailed as a cornerstone of India’s drug manufacturing sector, is facing an unprecedented crisis. Nearly 300 pharmaceutical companies in the state, especially in the Baddi-Barotiwala-Nalagarh (BBN) industrial belt, are reportedly on the verge of closure following the implementation of new, stringent policies by the Central Drugs Standard Control Organisation (CDSCO).


Industry representatives and trade associations have accused the central drug regulator of adopting an excessively bureaucratic and one-sided approach that is crushing small and medium enterprises (SMEs). Under the new risk-based inspection system, manufacturing units are inspected based on their “risk profile,” and any deficiencies identified during inspections result in immediate suspension of production.


While the CDSCO has argued that the new system is intended to strengthen public health and drug safety, industrial bodies claim that its execution has become excessively rigid and opaque, leaving small manufacturers struggling to survive.

Industry Outcry: ‘Don’t scare us, guide us’

An industrialist criticised the policies of the Drugs Controller General of India (DCGI), calling them “harsh, unilateral, and out of touch with ground realities.” He alleged that the regulator’s focus appears limited to large corporations, ignoring the practical difficulties faced by small and medium-sized manufacturers.


“Instead of guiding the industry, the regulator is intimidating it,” he said, adding that the CDSCO has sidelined small-scale industries from the policy-making process and stopped consulting key stakeholders.
A member of the Small Industries Association echoed these sentiments, warning that Himachal’s pharmaceutical units are being unfairly targeted under the new risk-based inspection regime.

“Nearly 300 small pharma companies are at risk of closure, threatening the livelihoods of thousands of workers,” he said.
He also questioned the logic behind repeated scrutiny of units that already hold valid licenses issued after joint inspections by state and central authorities. “If the licensing process was credible, why are the same units being subjected to aggressive re-inspections?” he asked.

Impact on employment and India’s global image

Industry groups fear that the fallout could be severe — not just for Himachal Pradesh but for the entire country’s pharmaceutical reputation. “India’s identity as the ‘Pharmacy of the World’ has been built by these small and medium enterprises,” an industrialist said. “If these units shut down due to policy imbalance, it will deliver a major blow to both employment and industrial credibility.”


The associations have urged the Central Government and the Ministry of Health to intervene immediately and introduce a balanced regulatory framework that ensures quality standards without crippling small manufacturers.


Experts warn that unless the government steps in, the risk-based inspection policy, in its current form, could lead to widespread shutdowns, loss of jobs, and a dent in India’s global pharmaceutical standing.
As the BBN industrial hub watches anxiously, the future of hundreds of small pharma units—and the workers who depend on them—hangs in the balance.

TNR News Network

TNR News Network

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