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 Table of Contents  
Year : 2016  |  Volume : 2  |  Issue : 1  |  Page : 64-65

News from regulatory corner

Date of Web Publication15-Jun-2016

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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2455-3972.184097

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How to cite this article:
. News from regulatory corner. Indian J Drugs Dermatol 2016;2:64-5

How to cite this URL:
. News from regulatory corner. Indian J Drugs Dermatol [serial online] 2016 [cited 2024 Mar 2];2:64-5. Available from: https://www.ijdd.in/text.asp?2016/2/1/64/184097

  Safety Warning; Proton Pump Inhibitors May Cause Subacute Lupus Erythematous Top

Proton pump inhibitors commonly used for acid peptic disorders are found to be associated with infrequent case reports of subacute lupus erythematosus (SCLE). Proton pump inhibitor should be discontinued if the patient presents with cutaneous lesions of SCLE and arthralgia unless it is absolutely required for a severe acid-peptic disease. Symptoms are known to resolve after drug discontinuation (source: WHO drug information 2015 vol. 29; No. 4, p. 451).

  Mycophenolate Mofetil Should Be Avoided in Pregnancy Top

European Medicines Agency has provided updated evidence on the significant risk of mycophenolate mofetil causing birth defects and spontaneous abortion when prescribed in pregnant women. Benefit-risk analysis should be done before prescription of mycophenolate mofetil during pregnancy. Mycophenolate can persist in blood for 6 weeks after treatment and in sperm for 90 days after treatment (source: WHO drug information 2015 vol. 29; No. 4, p. 454).

  Ceftriaxone Can Cause Acute Generalized Exanthematous Pustulosis Top

There are reports of acute generalized exanthematous pustulosis after treatment with ceftriaxone sodium hydrates in Japan and other countries. Information about this side effect has been labeled now in the product insert (source: WHO drug information 2015 vol. 29; No. 4, p. 455).

  Who Recommends Treatment for All People Living With Hiv Top

WHO-Geneva has published new guidelines recommending that anyone with HIV infection should be started with antiretroviral therapy (ART) as soon as the diagnosis is made. Recent reports from clinical trials conducted confirm that early use of ART helps in keeping people infected with HIV alive, healthier, and reduces the risk of transmitting the virus to partners (source: WHO drug information 2015 vol. 29; No. 4, p. 477).

  A Few Steroid Containing Fixed Drug Combinations Banned Top

Director General of Health Sciences (DCGI), Ministry of Health and Family Welfare of Government of India through Gazette notification on March 10, 2016, has issued the following order:

“Whereas, the Central Government is satisfied that the use of the following fixed dose combination of drugs is likely to involve risk to human beings whereas safer alternatives to the said drug are available; and whereas, the matter has been examined by an Expert Committee appointed by the Central Government and the said Expert Committee recommended to the Central Government that the said drug is found to have no therapeutic justification; and whereas on the basis of the recommendations of the said Expert Committee, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of the said drug in the country; Now, therefore, on the basis of the recommendations of the said Expert Committee and in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture of certain fixed dose combinations with immediate effect.”

Of many fixed drug combinations banned as per above order, following FDCs are of immense relevance to dermatology practice in India.

  • Lignocaine + clotrimazole + ofloxacin + beclomethasone
  • Ciprofloxacin + fluticasone + clotrimazole + neomycin
  • Chloramphenicol + beclomethasone + clomitrimazole + lignocaine
  • Clotrimazole + ofloxacin + lignocaine + glycerin and propylene glycol
  • Chloramphennicol + lignocaine + betamethasone + clotrimazole + ofloxacin + antipyrine
  • Ofloxacin + clotrimazole + betamethasone + lignocaine
  • Gentamicin sulfate + clotrimazole + betamethasone + lignocaine
  • Clotrimazole + beclomethasone + ofloxacin + lignocaine
  • Gentamycin + dexamethasone + chloramphenicol + tobramycin + ofloxacin
  • Ketotifen + cetirizine
  • Betamethasone + fusidic acid + gentamycin + tolnaftate + iodochlorhydroxyquinoline (ICHQ)
  • Clobetasol + ofloxacin + miconazole + zinc sulfate
  • Clobetasole + gentamicin + miconazole + zinc sulfate
  • Beclomethasone + clotimazole + neomycin + lodochlorohydroxyquinone
  • Ciprofloxacin + fluocinolone + clotrimazole + neomycin + chlorocresol
  • Clobetasol + ofloxacin + ketoconazole + zinc sulfate
  • Betamethasone + gentamicin + tolnaftate + ICHQ
  • Clobetasol + gentamici n + tolnaftate + lodochlor hydroxyquinone + ketoconazole
  • Allantoin + dimethiceone + urea + propylene + glycerin + liquid paraffin
  • Acriflavine + thymol + cetrimide
  • Betamethasone + neomycin + tolnaftate + lodochlorohydroxyquinoline + cholorocresol
  • Clobetasol + neomycin + miconazole + clotrimazole
  • Ketoconazole + tea tree oil + allantion + zinc oxide + aloe vera + jojoba oil + lavander oil + soa noodles
  • Clobetasol propionate + ofloxacin + ornidazole + terbinafine
  • Clobetasol + neomycin + miconazole + zinc sulfate
  • Beclomethasone dipropionate + neomycin + tolnaftate + ICHQ + chlorocresol
  • Betamethasone + gentamycin + zinc sulfate + clotrimazole + chlorocresol
  • Beclomethasone + clotrimazole + gentamicin + ICHQ
  • Clotrimazole + beclomethasone + lignocaine + ofloxacin + acetic acid + sodium methyl paraben + propyl paraben.

This is the very important development on the Indian regulatory front and is a good step by Government of India to promote principles of drug safety.

Source: http://www.cdsco.nic.in/writereaddata/GSR705E.pdf

(This is compiled by editorial team for the purpose of information only and content may change or may have changed until the time of publishing).


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