Amendment of Drugs Rules 1945
Source: Indian Express
GS II: Government Policies and Interventions, Issues relating to Development and Management of Social sector/ services relating to Health
Overview
- News in Brief
- Key Changes in the New Rules
Why in the News?
The Union Health Ministry has amended the Drugs Rules, 1945 by removing cough syrups and other syrup-based medicines from Schedule K.
News in Brief
- The Drugs (Fifth Amendment) Rules, 2026 ends the over-the-counter (OTC) sale of these medicines and mandates their sale through licensed pharmacies.
- These medicines will now be available only through licensed pharmacies and generally require a doctor’s prescription.
- The decision aims to strengthen drug safety and regulatory oversight following concerns over contaminated cough syrups linked to child deaths in Madhya Pradesh.
Key Changes in the New Rules
End of OTC Sale of Cough Syrups
- Cough syrups can no longer be freely sold as over-the-counter medicines.
- Consumers must obtain them through licensed pharmacies.
Stricter Regulatory Oversight
- Syrup-based formulations are now subject to stronger monitoring and compliance requirements.
- The measure aims to improve traceability and accountability in the supply chain.
Uniform Rules Across India
- The earlier exemption for sale in village has been withdrawn.
- Rural areas will now follow the same regulatory standards as urban areas.
- Sale and dispensing of cough syrups in smaller villages will required to take place only through duly licensed pharmacies in accordance with the provisions of the Drugs and Cosmetics Act, 1940.
What is Schedule K?
- A provision under the Drugs Rules, 1945.
- It lists certain categories of medicines that are exempt from specific licensing and prescription requirements.
- Earlier, some cough syrups could be sold under these exemptions, especially in small villages with a population of less than 1000 and with limited pharmacy access.
- With the latest amendment, “syrups” have been removed from the exemption list.
Why did the Government take this step?
- Contaminated Cough Syrup Incidents
- Several incidents involving contaminated cough syrups resulted in child deaths in India and other countries.
- Public Health Concern
- Self-medication and misuse of cough syrups have been longstanding concerns.
- Some formulations contain substances that may pose health risks if used improperly.
- Propylene Glycol- source of contamination.
- Contamination with diethylene glycol and ethylene glycol can occur when non-pharmaceutical grade polyethylene glycol (PEG) or other solvents are used in syrup manufacturing without inadequate quality testing.
- Strengthening Drug Safety
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- The government aims to improve quality control, responsible dispensing and consumer safety.
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Constitutional and Legal Framework
- Drugs and Cosmetics Act, 1940
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- Governs the manufacture, sale, and distribution of drugs in India.
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- Drugs Rules, 1945
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- Provides detailed regulatory provisions, including Schedule K exemptions.
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- Drugs (Fifth Amendment) Rules, 2026
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- Introduced the latest changes, removing syrup formulations from Schedule K.
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Key Takeaways
UPSC Prelims Practice Question
Consider the following statements regarding Schedule K under the New Drugs Rules
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- Schedule K provides exemptions from certain licensing and prescription requirements for specified classes of drugs.
- The Government has recently removed cough syrups from Schedule K exemptions.
- Lozenges and tablets for cough have also been removed from Schedule K.
How many of the statements given above are incorrect?
a) only one statement
b) only two statements
c) All three statements
d) None
Answer: a) only one statement
Explanation: Statement 3 is incorrect. Lozenges and tablets for cough continue to remain under the exemption lists.
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