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328 combination drugs banned over safety worries

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In a bid to stop the irrational use of fixed-dose combination (FDC) medicines, the Union health ministry on Wednesday banned the manufacture, sale or distribution of 328 varieties of FDC drugs for human consumption. Combination products, also known as fixed-dose combinations (FDCs) drugs, are combinations of two or more active drugs in a single dosage form. The decision has been taken by the health ministry after the Drugs Technical Advisory Board recommended that there's no therapeutic justification for the ingredients contained in 328 FDC drugs, and that these may involve risk to human beings. The action has been taken under Section 26A of the Drugs and Cosmetics Act, 1940 in the larger public interest. Talking to Mail Today, Delhi's drug controller Dr Atul Nasa, said, " It is a good move by the government to ban combination drugs. It has been seen that there was no rational use of FDC medicines. Previously, in March 2010, the government had brought the noti...

Doctors Body May Collate List of `Unsafe' Combo Drugs

IMA plans move after Delhi HC quashes govt ban on over 300 combination drugs Now that the Delhi High Court has quashed a government ban on over 300 combination medicines, a body of doctors has asked the central drug regulator whether these medicines are unsafe and shouldn't be prescribed. The body also said it may collate its own list of combination drugs that are “irrational“ and “unsafe“ to prescribe. The Indian Medical Association (IMA), which represents over 2 lakh doctors, wrote to Drug Controller General of India (DCGI) GN Singh after the Delhi court's verdict, people familiar with the development told ET. IMA's letter suggests that the ban notifications were quashed on December 1 mainly over procedurerelated issues ­ that the government exercised power under the Drugs & Cosmetics Act without consulting the Drugs Technical Advisory Board and Drugs Consultative Committee. The government should “immediately challenge” the decision in a higher cour...

Delhi high court sets aside Centre's decision to ban 344 fixed dose combination medicines

The Delhi high court on Thursday set aside the Centre's decision to ban 344 fixed dose combination (FDC) medicines, including well known brands like Corex cough syrup, Vicks Action 500 extra and D'Cold. The court pronounced its order after hearing arguments of companies like Pfizer, Glenmark, Procter and Gamble and Cipla, the central government and some NGOs like All India Drug Action Network (AIDAN) over a span of over two months, starting from March 14. The court had on March 14 stayed the Centre's March 10 ban on 344 FDC drugs and this interim order was passed in each and every case filed before it thereafter. During arguments, the drug companies had contended that the government has not properly implemented the powers under section 26A (power to prohibit manufacture of drugs and cosmetics in public interest) of Drugs and Cosmetics Act, under which the ban was ordered. They had also argued that the ban order was passed without considering clinical data...

Recently banned list of combination drugs by DCGI

1.    Aceclofenac + Paracetamol + Rabeprazole 2.    Nimesulide + Diclofenac 3.    Nimesulide + Cetirizine + Caffeine 4.    Nimesulide + Tizanidine 5.    Paracetamol + Cetirizine + Caffeine 6.    Diclofenac + Tramadol + Chlorzoxazone 7.    Dicyclomine + Paracetamol + Domperidone 8.    Nimesulide + Paracetamol dispersible tablets 9.    Paracetamol + Phenylephrine + Caffeine 10. Diclofenac + Tramadol + Paracetamol 11. Diclofenac + Paracetamol + Chlorzoxazone + Famotidine 12. Naproxen + Paracetamol 13. Nimesulide + Serratiopeptidase 14. Paracetamol + Diclofenac + Famotidine 15. Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol 16. Omeprazole + Paracetamol + Diclofenac 17. Nimesulide + Paracetamol injection 18. Tamsulosin + Diclofenac 19. Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine 20. Diclofenac + Zinc Carnosine...