Government bans SARIDON, COREX and 326 other combination drugs
Goverment bans SARIDON, COREX and 326 other combination drugs:-The health ministry has banned the manufacture, sale and distribution of 328 fixed dose combinations (FDCs) of drugs with immediate effect and restricted another six. This brings to an end a protracted legal battle between manufacturers of these combination drugs and the ministry, which has been working since 2016 to get these “irrational” and “unsafe” drugs banned.
Among the roughly 6,000 brands estimated to be affected by the ban are popular drugs like the painkiller Saridon, the skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ.
The government had banned 344 FDCs on March 10, 2016 and later added five more to this list. However, manufacturers of these drugs contested the ban in various high courts and the Supreme Court. The SC on December 15, 2017 asked for the matter to be examined by the Drugs Technical Advisory Board. DTAB concluded in its report that there was no therapeutic justification for the ingredients in 328 FDCs and that these could be a risk to people. The board recommended banning them.
In the case of six other FDCs, the board recommended restricted manufacture and sale subject to certain conditions based on their therapeutic justification. The SC ruled that the government could not use the DTAB report to prohibit 15 of the 344 drugs in the original list as these have been manufactured in India since before 1988. This exception covered several popular cough syrups, painkillers and cold medication with sales amounting to over Rs 740 crore annually. However, the court told the ministry that it could still look into the safety of these 15 drugs by initiating a fresh investigation if it wanted to ban them
The All India Drug Action Network, a civil society group working on safety and access to medicines which was one of the petitioners in the Supreme Court case, welcomed the ban and sought swift action from the government on the 15 excluded FDCs. “The banned FDCs account for about Rs 2,500 crore and represent only the tip of the iceberg. In our estimate, the market for unsafe, problematic FDCs in India is at least one-fourth of the total pharma market which is valued at Rs 1.3 trillion,” said AIDAN in a statement. It also sought a review of all FDCs in the market in the interest of patient safety as recommended by the Kokate Committee, constituted by the health ministry to examine FDCs.
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Meanwhile, many large drug companies have claimed that over the last couple of years they have either phased out such drugs or changed the combination. The FDCs in question are less than 2%, they claim.
Here is the full list
Combination drugs are used to improve patients’ compliance, as it is easier to get patients to take one drug rather than several.
In a blow to both domestic and foreign pharmaceutical firms, the central government has banned a total of 329 fixed drug combinations (FDC). However, the ban has been lauded by health activists worried about growing antibiotic resistance due to the misuse of medicines.
FDC means a combination of two or more drugs in a fixed dosage ratio. Some of the banned drugs were: Cefixime + Azithromycin, Ofloxacin + Ornidazole Suspension, Metronidazole + Norfloxacin, and Paracetamol + Propyphenazone + Caffeine (trade name Saridon).
List of 329 combination drugs banned in India:
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In July, an expert panel of the health ministry, after reviewing 349 fixed drug combinations (FDCs), had recommended that 343 of them should be “prohibited” and the remaining six should be “restricted or regulated”. In December last year, the Supreme Court had directed the health ministry’s expert body, Drugs Technical Advisory Board (DTAB), for a fresh review of safety, efficacy and therapeutic justification of these 349 FDCs. Therefore, the DTAB formed a sub-committee, which studied the issue and submitted its recommendations.
Total 344 FDCs were banned on March 10, 2016, by the central government on the suggestion of the panel formed under the chairmanship of C K Kokate. Kokate committee, which studied the irrationality of various FDCs, recommended the ban on 344 of them, citing the rising “antibiotic resistance” in the country as one of the reasons. Antibiotic resistance is the ability of a microorganism, which is causing the disease, to withstand the effects of an antibiotic medicine.