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Govt Bans Saridon and 327 Other Drugs Due to Health Risk to Patients
News 18,  13 September 2018
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Around 6,000 medicine brands with a combined market size of Rs 2,000-2,500 crore may soon vanish from the drug market in the country.

New Delhi: The Ministry of Health on Wednesday banned the manufacture for sale or distribution of 328 fixed-dose combination (FDC) drugs with immediate effect.

Besides, it has also restricted the manufacture, sale or distribution of six FDCs subject to certain conditions, an official statement said. The banned medicines include brands like Piramal’s Saridon, Alkem Laboratories’ Taxim AZ and Macleods Pharma’s Panderm Plus cream.

Government sources said the move means that around 6,000 medicine brands belonging to different companies and with a combined market size of Rs 2,000-2,500 crore may soon vanish from the drug market in the country. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

The Health Ministry, through its notification published on March 10, 2016, had prohibited the manufacture for sale and distribution for human use of 349 FDCs under Section 26 A of the Drugs and Cosmetics Act, 1940.

But the matter was contested by the affected manufacturers in various high courts and the Supreme Court. Complying with the Supreme Court verdict in December last year, an expert panel formed by the Drugs Technical Advisory Board (DTAB), in its report to the Centre, stated that there is no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs may involve risk to human beings, the statement stated.

DTAB said these combinations may lead to overuse. According to the technical body, there is no need to expose the patients to that many ingredients when one will do the work. The notification stated, “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC…any kind of regulation or restriction to allow for any use in patients is not justifiable.”

The Board recommended that it is necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.

(With PTI inputs)


Comments

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  • Dr Nadeem Akhtar 17 September - 06:48 hrs

    Good move

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  • Dr Nadeem Akhtar 17 September - 06:46 hrs

    Good move

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  • Dr Satish Samriya 15 September - 12:27 hrs

    Complete list: https://medibulletin.com/here-is-the-complete-list-of-drugs-banned-by-govt-of-india/

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  • Dr K Chandra shekar 15 September - 11:31 hrs

    Dear Sir / Madam For the benefit of the Doctors Community it would be good if we can list all the banned drugs so that we can stop writing them inspite of the false assurance that may be given by the manufacturers and the medical representatives. Can you help us with the list

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  • Dr Sadasivan Ramalingam 14 September - 17:56 hrs

    Excellent job though late

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  • Dr RAVINDRA Babu Malepati 14 September - 15:18 hrs

    Long overdue

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  • Dr Shyam Sundar Singh 14 September - 10:49 hrs

    Great

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  • Dr Anil Kumar Sharma 14 September - 06:22 hrs

    Good ,long awaited action.

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  • Dr Gaurav Chhaya 13 September - 22:22 hrs

    need to find list to improve database and patient care.

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  • Dr dhiren mahida 13 September - 21:11 hrs

    a good step by the government

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  • Dr DR.SUDHIR KANT SHARMA 13 September - 20:47 hrs

    Long Awaited action by This Government. Welcome Welcome Welcome. These Foolish formulas are Killing More People Than the Illness or Self Medication in our Country. Must be Implemented with Honesty of Drug Inspector..

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  • Dr Ravindra Garg 13 September - 19:33 hrs

    Better late than never

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  • Dr Narsing Padhi 13 September - 16:12 hrs

    Many of the FDCs were selling only on dubious reputation. I think it’s a timely action. It will also prevent profiteering by pharma companies. I wish the DTAB reviews many other useless, costly and dangerous drugs,including many Ayurvedic and Homeo drugs. Drugs making unreal claims of efficacy and cures also need to be banned. Protctthe innocent citizens is my appeal.

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  • Dr anand kamat 13 September - 16:08 hrs

    Nice move by govt.

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