Alert on Meftal Painkiller: IPC Flags Safety Concerns
Explore the Complete List of Banned Fixed Combination Drugs for Human Use in India in 2023 Following the Issued Alert.
The recent cautionary signal from the Indian Pharmacopoeia Commission (IPC) regarding the popular painkiller Meftal has triggered concerns about its safety. Meftal, recognized for its mefenamic acid content, is commonly prescribed for a spectrum of conditions, including rheumatoid arthritis, osteoarthritis, dysmenorrhoea, mild to moderate pain, inflammation, fever, and dental pain.
Understanding the Risks: DRESS Syndrome
The commission’s alert stems from a preliminary analysis of adverse drug reactions gleaned from the Pharmacovigilance Programme of India (PvPI) database. The findings shed light on instances of drug reactions associated with eosinophilia and systemic symptoms (DRESS) syndrome. This condition, characterized by severe skin rashes and internal organ involvement, underscores the importance of vigilant monitoring of Meftal’s usage.
Proactive Measures: Banning Fixed Combination Drugs in 2023
In response to the raised alarm, regulatory actions have been swift. A list of fixed combination drugs prohibited in India for human use in 2023 has been unveiled. These drugs, known for their combined formulations, have been subject to stringent scrutiny. The aim is to ensure the safety and well-being of patients who might be at risk due to potential adverse reactions.
Notable Entries in the Banned List:
1. Nimesulide + Paracetamol Dispersible Tablet
2. Amoxicillin+ Bromhexine
3. Pholcodine + Promethazine
4. Fixed dose combination of Chlorpheniramine maleate + Dextromethorphan + Guaiphenesin + Ammonium
5. Chlopheniramine Maleate + Codeine Syrup
6. Ammomium Chloride + Bromhexine + Dextromethorphan
7. Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
8. Dextromethorphan + Chlorpheniramine Guaiphenesin + Ammonium Chloride
9. Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin
10. Salbutamol + Bromhexine.
11. Chlorpheniramine + Codeine Phosphate Menthol Syrup
12. Phenytoin + Phenobarbitone sodium.
13. Ammonium Chlande Sodium Carate Chlorpheniramine Maleate Merishok (100mg 40mg 25mg + 0 mg) (125mg 55mg Angling) (110mg 40mg+ang+0 mg) (130mg 55ing 3mg 0.5mg) per 5ml syrup
14. Sallbutamol + Hydroxyethyltheophylline (Etofyline) Bromhexine
This comprehensive approach seeks to prevent potential harm arising from drug combinations that may pose an increased risk of adverse reactions or side effects.
Quality Quandaries in Indian Cough Syrup
Beyond Meftal, recent investigations into a cough syrup have revealed unsettling quality issues, adding another layer to concerns about the safety of pharmaceutical exports from India. This particular cough syrup, linked to the tragic deaths of at least six children in Cameroon, underwent testing, exposing unidentified quality concerns in one of the five samples examined.
Key Player: Riemann Labs and Global Impact:
Riemann Labs, one of the prominent Indian drugmakers, finds itself under intense scrutiny. Cough syrups manufactured by Riemann Labs have been linked to the deaths of over 141 children in Gambia, Uzbekistan, and Cameroon since the middle of the previous year. This has cast a shadow on India’s reputation as the “world’s pharmacy,” known for supplying life-saving drugs at affordable prices to nations in dire need.
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Toxicity Unveiled: WHO’s Involvement and Regulatory Response
In July of the previous year, the World Health Organization (WHO) brought attention to a sample from Cameroon’s Naturcold syrup, attributed to Riemann. The sample contained a staggering 28.6 percent of the toxin diethylene glycol, surpassing the acceptable limit of 0.10 percent. In response to this revelation, Indian authorities promptly suspended Riemann’s production, citing violations of good manufacturing practices.
An inspection conducted at Riemann’s factory in June had uncovered violations, including improper ventilation, elevating the risk of cross-contamination. This incident marked a turning point, prompting stringent regulatory measures to safeguard the integrity of pharmaceutical production.
Global Ramifications: WHO’s Probe and Previous Incidents
This is not the first instance of WHO’s involvement in investigating the supply of contaminated cough syrups originating from India. In June of the previous year, WHO’s probe identified seven Made-in-India products linked to the supply of contaminated cough syrups worldwide. These incidents resulted in the tragic deaths of more than 60 children in Gambia and around 20 in Uzbekistan.
These global ramifications underscore the need for heightened vigilance and stringent quality control measures in the pharmaceutical industry, especially in a country pivotal to global healthcare provision like India.
Navigating Challenges in the Pharmaceuticals Sector
In conclusion, the unfolding events surrounding Meftal’s safety concerns, the banning of fixed combination drugs, and the quality issues in Indian cough syrups spotlight the intricate challenges faced by the pharmaceutical sector. These incidents prompt a critical reassessment of regulatory frameworks, manufacturing practices, and global supply chain standards to ensure the safety of medications and uphold the trust placed in India’s role as a major pharmaceutical provider on the world stage.
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