On March 10, 2016, the Central Drugs Standard Control Organisation (CDSCO) issued a notification prohibiting the manufacture, sale and distribution of 344 Fixed Dose Combinations (FDCs) drugs.
Importantly, the Indian Central government has imposed the ban by exercising its powers under Section 26A of the Drugs and Cosmetics Act, 1940. This provision allows the “government to prohibit the manufacture, sale or distribution of drugs that are likely to pose a risk to human beings or animals, or that do not have the therapeutic value that they claim, or contain ingredients in quantities for which there is no therapeutic justification”.
The Drug majors blocked sale of their prominent cough syrups Corex and Phensedyl respectively, after the government banned around 344 FDC drugs. The sale and manufacturing of drugs has been discontinued with prompt effect by their manufacturers including the leading FMCG players like Procter and Gamble (P&G), Pfizer, Abbott, etc.
The list of drugs that may go off the chemists’ shelves:
• Procter and Gamble (P&G): Vicks Action 500 Extra
• Abbott: Cough Syrup Phensedyl, Tossex and triple combination diabetes drug Tribet
• Cipla: Triple combination diabetes drug Triexer most impacted
• Pfizer: Cough Syrup Corex
• Lupin: Triple combination diabetes drug Gluconorm most impacted
• Wockhardt: Zedex cough syrups, Ace Proxyvan impacted
• Glenmark: Most of the impact is on account of Ascoril range of cough syrups
• Ipca: Zerodol P (Paracetamol + Aceclofenac)
• Sun Pharma: The most impacted is triple anti diabetes combination drug Gemer P (Meltformin + pioglitazone + glimeperide)
• Alkem: Sumo (Nimesulide + Paracetamol) and Taxim AZ (Azithromycin + Cefixime)
• Mankind: The impact is spread across multiple products
• Macleods: Panderum Plus
"The company is exploring all available options at its disposal. The constraint is likely to have an adverse impact on the revenue and profitability of the company," Pfizer reported in its BSE filing. Pfizer further said that the banned drug, particularly the Corex has a well entrenched efficacy and safety profile in India for over 30 years.
However, the Delhi High Court granted an interim stay on the ban until March 28, 2016 saying that the interim stay has been granted on the grounds that the drug has been marketed for 25 years and that the notification banning it does not disclose any “grave urgency”. Importantly, in an affidavit, the Indian government has argued that lifting the ban would be “against public interest and patient safety”. It also claimed that the pharma companies were interested only in profit.
While the ban has been challenged, the question remains as to how these drugs were allowed to enter the Indian market in the first place, if they were so dangerous for an average consumer.