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Tag: DCGI

  • Hyderabad-based IIL get DCGI nod for Measles-Rubella vaccine

    Hyderabad-based IIL get DCGI nod for Measles-Rubella vaccine

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    Hyderabad-based IIL get DCGI nod to make Measles-Rubella vaccine

    Hyderabad: The vaccine makers based in Hyderabad, Indian Immunologicals Limited (IIL), have received approval from the Drugs Controller General of India (DGCI) and Telangana State Drug Control Administration (TSDCA) for manufacturing its Measles-Rubella (MR) Vaccine.

    As an outcome of the Indo-Vietnam partnership, the product has been in the works for more than six years and for which IIL is collaborating with Vietnam’s Center for Research and Production of Vaccines and Biologicals, also known as Polyvac.

    Vietnam under Polyvac will supply the Measles vaccine to Indian Immunologicals while the Rubella vaccine will be produced by IIL to manufacture a combined MR vaccine.

    The live attenuated MR vaccine is an addition to the list of several other vaccines that IIL supplies to the Universal Immunization Programme (UIP) of India.

    “The MR vaccine of IIL has been proven through extensive human clinical trials to be immunogenic and safe for people of 9 months to 49 years,” stated a press release.

    Managing director of IIL, Dr K Anand Kumar, while speaking on the occasion said, “We started with humble beginnings with Polyvac in 2016 and worked tirelessly throughout including the tough Covid-19 period.”

    “Measles-Rubella (MR) vaccine is listed in the UIP of India and is an important vaccine for our country,” added the MD.

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    ( With inputs from www.siasat.com )

  • DCGI sends notice to e-pharmacies for selling drugs without license

    DCGI sends notice to e-pharmacies for selling drugs without license

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    New Delhi: The Drugs Controller General of India (DCGI) has issued a showcause notice to online pharmacies, seeking an explanation on why action should not be taken against them for selling and distributing drugs in contravention of provisions of the Drugs and Cosmetics Act 1940.

    The notice was issued to online pharmacies including — Tata 1mg, Amazon, and Flipkart on Friday.

    “The office has received various representations from time to time raising concerns regarding the sale of drugs through online, the internet or other electronic platforms, including various mobile applications, in contravention to the provisions of the Drugs and Cosmetics Act, 1940 & Rules there under,” the DCGI notice to the e-pharmacies read.

    “Such sale includes drugs specified in Schedule H, HI and X which are only allowed to be sold under a valid prescription of a registered medical practitioner and supplied under the supervision of a registered pharmacist,” the notice read.

    “In this regard, it may be mentioned that import, manufacture for sale or for distribution, or sale, or stock or exhibit or offer for sale or distribution of any drug are regulated under the provisions of the Drugs and Cosmetics Act, 1940 & Drugs Rules 1945 made there,” it stated.

    The DCGI in the notice further said that for sale, or stock or exhibit or offer for sale or distribution of any drug, a license is required to be obtained from the concerned state licensing authority and conditions of license are required to be complied by the licensee. “There are cases in various courts in this regard requesting to prohibit the online sale of drugs,” it said.

    “In view of the above, you are hereby asked to show cause within 2 days from the date of issue of this notice, why action shall not be taken against you for sale, or stock or exhibit or offer for sale or distribution of drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules made there under. In case no reply is received, it will be presumed that you have nothing to say in this matter and necessary action shall be initiated against you without any further notice.”

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    ( With inputs from www.siasat.com )