Last Updated on March 20, 2025 by The Health Master
Spurious drugs
The fight against spurious drugs in India is demanding prompt action required in coordination with all stakeholders.
Dr. BR Jagashetty, a seasoned veteran in drug regulation, emphasizes the pressing need for a unified front between State Licensing Authorities (SLAs), the Central Drugs Standard Control Organization (CDSCO), and pharmaceutical manufacturers.
This isn’t just about action on culprits; it’s also about safeguarding public health by means of a transparent and robust regulatory system in India.
The Power of Collaboration: Bridging the Regulatory Gap
One of the core issues highlighted by Dr. Jagashetty is the lack of seamless information sharing.
“Both SLAs and CDSCO should share data on reported spurious drugs,” he asserts.
This simple act of data exchange can significantly enhance the ability to track and intercept spurious drugs.
Regular inspections, audits, and cross-verification between state and central authorities are essential components of this collaborative approach.
Real-time information sharing is very important to combat the spread of spurious drugs in the area.
Track and Trace
Dr. Jagashetty revisits a crucial recommendation from 2011: mandating track and trace for every batch of drug, right down to the retail point.
“This system may help in finding the counterfeit or spurious drugs to some extent,” he notes.
Implementing the technologies, e.g., traceability of drugs or implementation of QR codes on packaging of drugs, can make this process efficient, which may add a layer of accountability and transparency.
Reforming Licenses:
The current licensing policy is also under scrutiny, which restricts SLAs to granting licenses only in generic names.
Dr. Jagashetty proposes withdrawing the 2012 direction and allowing SLAs to grant licenses in brand names, with a suitably increased fee.
“Instead of Rs. 300 as prescribed under drug rules, this will need to be enhanced suitably for each additional product with or without brand name,” he suggests.
This move aims to streamline the licensing process while generating additional revenue for regulatory activities.
Look-alike, sound-alike drugs:
Look-alike, sound-alike (LASA) drugs pose a high risk to patient safety.
Dr. Jagashetty suggested that the CDSCO and SLAs must develop a robust monitoring system to address this issue in the public interest.
He also suggested that stringent regulations be required for propaganda drugs to ensure that only legitimate and safe drugs reach the market.
Manufacturer Compliance and Public Awareness
Pharmaceutical manufacturers have a pivotal role to play in ensuring drug quality.
Pharmaceutical manufacturers must strictly adhere to the latest Schedule-M guidelines to ensure the quality of raw materials, manufacturing processes, and distribution systems.
“Manufacturers, together with regulatory authorities, can conduct awareness programs to educate healthcare providers, pharmacists, and the general public about the dangers of spurious drugs and the mode of identifying them,” Dr. Jagashetty states.
Leveraging Technology and whistleblower Schemes
The integration of artificial intelligence (AI) and blockchain technology can enhance drug traceability and supply chain transparency.
Furthermore, promoting a robust whistleblower scheme with proper protection for those who report suspicious activities, is crucial.
“Here it needs to be ensured that their protection is through proper whistleblower policies in place both at state and central level,” Dr. Jagashetty emphasizes.
Key Actions for Eradication:
- Strengthen data sharing between SLAs and CDSCO.
- Mandate track and trace for all drug batches.
- Restructure the licensing policies to allow approval of permission for brand names with increased fees.
- Regulation must be stringent for LASA drugs and propaganda products.
- Manufacturer compliance must be strictly complied with at par with Schedule-M guidelines.
- Conduct public awareness campaigns on spurious drugs.
- Blockchain and AI technology must be implemented for supply chain transparency.
- Promote and protect whistleblowers.
Q. What are spurious drugs?
A. Spurious drugs are the drugs that may contain incorrect ingredients, no active ingredients, or harmful substances.
Q. Why is coordination between SLAs and CDSCO important?
A. Coordination coordination between SLAs and CDSCO allows for prompt and real-time sharing of information for efficient inspections, and a unified action against culprits involved in the activities of spurious drugs.
Q. How can technology help in preventing spurious drugs?
A. Technologies like AI and blockchain can enhance drug traceability, making it easier to identify and track spurious drugs.
Q. What is Schedule-M?
A. Schedule-M outlines the Good Manufacturing Practices (GMP) that pharmaceutical manufacturers must adhere to in India.
Q. How can I report a spurious drug?
You can report suspected spurious drugs to your local State Licensing Authority (SLA) or the Central Drugs Standard Control Organization (CDSCO).
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.
For articles by Dr. Bharatesh R Jagashetty, click here
7 Pharma Companies face action for Spurious Drugs: Pakistan
Spurious drugs seized in Telangana
Kolkata raid: Spurious drugs worth Rs 6.6 Crore seized
Spurious drugs: Low conviction rate a concern
Spurious Drug: New Rules for Medical Stores soon
Parliamentary Panel demands swift action on Spurious Drugs
Four arrested for supplying Spurious Drugs to Maharashtra Hospital
USFDA inspection: At JB Chemicals with Zero observations
Drug Recall: Sun Pharma, Zydus recall drugs due to this reason
Rifampicin: Expected to be commissioned this year
Panel recommends high standard Drug Regulation nationwide
USFDA inspection: At Shilpa Medicare with Zero observations
Karnataka cracking down on counterfeit drugs
Key Notes on Revised Schedule M: API Part-1
Drug recall: Dr. Reddy’s Recalls Levetiracetam in 0.75% Sodium Chloride Injection Due to this reason
Landmark Ban: Chloramphenicol and Nitrofurans Banned for Food Animals
USFDA approval granted for Methenamine Hippurate Tablets: Zydus
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
