Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Advisory issued against drug ‘Meftal’

Note4Students

From UPSC perspective, the following things are important :

Prelims level: Meftal drug

Mains level: Not Much

Central Idea

  • Pharma standard body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert for commonly used painkiller mefenamic acid, popularly sold under the brand name Meftal.

What is Meftal used for?

  • Meftal 500, a non-steroidal anti-inflammatory drug (NSAID) is usually prescribed in treatment for conditions like menstrual pain, headache, muscle, joint, or dental pain.
  • It has been advised to take the table with food.
  • The most common side effects of the medicine include mild vomiting, stomach pain, nausea, headache, and dizziness.

What does the alert against Meftal say?

  • IPC stated that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.
  • DRESS, also known as drug induced hypersensitivity syndrome, is an adverse drug reaction that can even be life threatening.
  • It may cause damage to several organs, especially to the kidneys, heart, lungs, and pancreas.
  • The mortality rate is high and is about 10 per cent.

Back2Basics: Indian Pharmacopoeia Commission (IPC)

Details
Establishment 1956,

An autonomous body under the Ministry of Health and Family Welfare

Primary Objective To promote public health by setting and updating standards for drug quality in India.
Key Publication Indian Pharmacopoeia (IP), a legally recognized book of drug standards.
Role in Drug Regulation Standards set in the IP are enforceable by law, crucial for India’s drug regulatory framework.
International Recognition Collaborates with WHO and aligns with global drug standards.
Pharmacovigilance Program Involved in monitoring and analyzing adverse drug reactions through the PvPI.
Quality Control & Training Engages in drug quality control and provides training to regulatory bodies and the pharmaceutical industry.
Publication Updates Periodically updates the IP to include new drugs and revise existing standards.
Collaboration Works with the pharmaceutical industry, academia, and regulatory bodies.
Global Harmonization Aims to harmonize the IP with international pharmacopoeias like the USP and BP.

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