Last Updated on August 4, 2025 by The Health Master
Pharma firms
In a significant move to uphold the drug standards, the Indian government has said that stringent actions have been taken to combat the menace of substandard and adulterated drugs.
Since late 2022, a nationwide inspection drive has been carried out at pharma firms that leads to decisive actions to increase the drug regulatory compliance and safeguard public health.
A Proactive Approach to Pharmaceutical Quality Control
The Central Drugs Standard Control Organisation (CDSCO), the principal regulatory body for pharmaceuticals and medical devices in India, started a comprehensive, risk-based inspection program in collaboration with state regulatory authorities in December 2022.
This collaborative effort with state regulators was designed to assess the drug manufacturing standards and regulatory adherence of drug manufacturing and testing facilities across the country.
Outcomes of the inspections and Regulatory Actions
Union Health Minister J.P. Nadda recently provided an update to Parliament regarding the inspection at pharma firms and action taken.
Out of a total of 905 drug manufacturing and testing firms inspected since the program’s inception, action has been taken against 694 pharma.
Here’s a breakdown of the actions taken:
Stop Production Orders:
Stop Production Orders have been issued to pharma firms where serious non-compliance was observed, immediately halting manufacturing operations.
Stop Testing Orders:
Stop testing orders issued to facilities whose testing procedures were found to be inadequate or compromised.
License Suspensions/Cancellations:
License Suspensions/Cancellations orders have been issued to the pharma firm wheresoever severe punitive measures were required, leading to the temporary or permanent revocation of a firm’s operational license.
Warning Letters:
Warning letters have been issued to the pharma firms; less serious observations were observed, requiring corrective actions within a stipulated period of time.
GMP compliance India is not merely a bureaucratic formality; it is a fundamental pillar that guarantees that drugs produced in India are consistently manufactured and controlled according to quality standards appropriate to their intended use and as required by the product specification.
Q: What is the role of CDSCO?
A: CDSCO’s primary role is to ensure the quality, safety, and efficacy of drugs and cosmetics manufactured, imported, and distributed in the country.
Q: What is meant by “not of standard quality” of a drug?
A: When a drug is declared “not of standard quality,” it means it fails to meet one or more of the quality specifications or standards prescribed for it.
Q: What is Good Manufacturing Practice (GMP)?
A: GMP is a set of guidelines having details of the minimum requirements that manufacturers must meet to ensure their products are consistently high in quality, safe, and effective.
Disclaimer: This article contains information obtained from the source mentioned below. Our team made changes in the format to rewrite and present the news or article in a unique format.
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