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Health Ministry bans 328 FDCs with immediate effect
eMediNexus,  13 September 2018
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#Business And Medicine #Pharmacist #Public Health

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The Ministry of Health and Family Welfare has prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs) with immediate effect. It has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions.

Earlier, the Central Government had, through its notifications published on the 10th March, 2016 in the Gazette of India, prohibited the manufacture for sale, sale and distribution for human use of 344 FDCs under section 26 A of the Drugs and Cosmetics Act, 1940. Subsequently, the Government had prohibited five more FDCs in addition to the 344 under the same provisions.

Accordingly, the Ministry of Health and Family Welfare has, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940, prohibited the manufacture for sale, sale or distribution for human use of 328 FDCs through its gazette notifications dated 7th September 2018; it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions. These notifications will take immediate effect. However, the matter was contested by the affected manufacturers in various High Courts and the Supreme Court of India. In compliance with the directions given by the Supreme Court of India in its judgment dated the 15th December, 2017, the matter was examined by the Drugs Technical Advisory Board constituted under section 5 of the Drugs and Cosmetics Act, 1940 which furnished its report on these drugs to the Central Government.

The Drugs Technical Advisory Board recommended, amongst other things, that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings. The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under section 26 A of the Drugs and Cosmetics Act, 1940 in the larger public interest. With regard to six FDCs, the Board recommended that their manufacture, sale and distribution be restricted subject to certain conditions based on their therapeutic justification. Fifteen FDCs out of the 344 prohibited on the 10th March, 2016, which were claimed to be manufactured prior to 21stSeptember, 1988, have been kept out of the purview of current notifications… (Press Information Bureau, Ministry of Health and Family Welfare, September, 12, 2018)


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  • Dr nagabhushana giriyappa raman 19 September - 10:26 hrs

    Yes all FDC Drugs are not banned.Thanks to Dr.agarwal.

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  • Dr Shashikant Chandwadkar 18 September - 07:37 hrs

    Plz.furnish d list of banned FDC

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  • Dr Hari Narayan Borkataky 15 September - 15:23 hrs

    A very praise worthy job o f the central government for the patients. Random drug manufacturing licence to business houses of non medical background should stop . Quality control and control on new combinations should be guided by established drug manufacturers with genuine research.

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  • Dr Narsing Padhi 15 September - 00:12 hrs

    It’s good that the authorities are thinking positively. The ban is timely and was necessary. Two more areas which require attention is more rigorous quality control of the myriad brands of the drugs and. Curb the marketing and sale of drugs of mixed pedigree, like Ayurvedic preps sold for indications which was unknown to Ayurveda. The so called Homeo pathi medices which are ineffective and useless should be banned.

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  • Dr Abhaya kumar Pal 14 September - 18:30 hrs

    When this drug is baned .Why this drugs is available in market

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  • Dr venkateshwar rajaraman 14 September - 14:38 hrs

    please give the list of banned drugs and aiso fixed dose combinations ,which are banned.

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  • Dr Abhay Deora 14 September - 11:29 hrs

    Action by the Govt in banning FDC drugs is justified as so many FDC had no rationale for their use

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  • Dr Sanjay Ranaut 14 September - 11:07 hrs

    Thats a welcome step,but what is being for the regular sampling and testing of the every batch of the allowed combinations that goes to the market for sale.There is a efficacy and quality issue of the sold drugs.

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  • Dr Anil kumar Patra 14 September - 10:51 hrs

    Excellent initiative!... Please circulate the list(both generic & branded Names for our knowledge!!

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  • Dr DR YAJNESWAR SAHOO 14 September - 10:36 hrs

    GREAT, SINGLE-WINDOW, TREASERY OF UP-DATED AND RECENT MEDICAL INFORMATIONS JUST SUPERB AND DELIGHTFUL

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