Last Updated on October 2, 2024 by The Health Master
Drug Recall
India’s drug regulatory landscape is facing a serious challenge. A recent surge in drug recall has raised significant concerns about the quality and safety of medications available to the public.
According to data from the Ministry of Health and Family Welfare, the fiscal year 2023-24 witnessed a record-breaking number of drug batches recalled by state and union territory drug regulators.
A Five-Year High in Drug Recall
The numbers are alarming.
State and union territory drug controllers collectively recalled a staggering 1,394 drug batches worth a total of Rs. 16.89 crore during the fiscal year 2023-24.
This represents a 19% increase in the number of recalled batches compared to the previous year.
Furthermore, the total value of recalled drugs has also risen by 2.5% to Rs. 16.47 crore.
Over the past five years, from 2019-20 to 2023-24, the cumulative number of drug recall stands at a worrying 5,759 batches, with a total value exceeding Rs. 36.10 crore.
Drug Adulteration and Substandard Quality
The problem extends beyond drug recall.
Drug regulators have intensified their scrutiny of drug quality in response to widespread reports of substandard and spurious medications.
In the fiscal year 2022-23 alone, approximately 96,713 drug samples were tested, with a shocking 3,053 found to be Not of Standard Quality (NSQ) and 424 classified as spurious or adulterated.
These figures represent a significant increase compared to the previous year.
Government Crackdown on Drug Manufacturers
To address this crisis, the Central Drugs Standard Control Organisation (CDSCO), in collaboration with State Drug Controllers, has launched a comprehensive crackdown on drug manufacturers.
Over 400 drug manufacturing premises have undergone risk-based inspections to assess their compliance with quality and safety standards.
Based on inspection findings, strict actions have been taken against non-compliant firms.
These measures include issuing show cause notices, halting production, suspending or canceling licenses, and revoking product licenses.
Strengthening Drug Regulations
The government is committed to ensuring the quality and safety of drugs in India.
Several initiatives have been implemented, including:
- Amendments to the Drugs and Cosmetics Act: To strengthen regulatory framework.
- Establishment of Special Courts: For speedy disposal of drug-related offenses.
- Increased Staffing: To bolster CDSCO’s capabilities.
- Mandatory Bioequivalence Studies: For oral dosage forms.
- Joint Inspections: By central and state drug inspectors before granting manufacturing licenses.
- Stricter Requirements for Manufacturing Licenses: Including evidence of stability and safety of excipients.
- Revised Good Manufacturing Practices: Through amendments to Schedule M of the Drugs Rules.
The Road Ahead
While these measures are a step in the right direction, the challenge of ensuring drug quality in India remains substantial.
Continued vigilance, robust enforcement, and public awareness are essential to protect public health and restore confidence in the country’s pharmaceutical industry.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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