2021-05-16 18:44:15

GUIDELINES FOR IMPORT OF COVID-19 VACCINES IN INDIA

The drug regulator has abolished the importation of Covid-19 vaccines by issuing a set of similar guidelines. Any private organization can import the Covid-19 vaccine if the vaccine is approved by the drug regulator and the import license is obtained from it, the Central Drugs Standards Control Organization (CDSCO) said. The latest guidelines for the importation of COVID-19 vaccines by private companies and national governments have been issued by the Central Drugs Standards Control Organization (CDSCO), India's drug regulator. For vaccines that have not been approved or licensed in India, the importer or authorized agents of foreign manufacturers must obtain the necessary three licenses or licenses from the CDSCO. These include the New Drug Permit under the New Drug Laws and Clinical Trials Rules, 2019; to obtain a registration permit under the Drugs Act, 1945 and a basic import license under the Drugs Act, 1945.

All submissions will need to be done in accordance with the guidelines of the Department of Health and Vaccine and the National Immunization Program COVID-19 from May 1, CDSCO said. The vaccine can be imported for distribution to national and private organizations, in accordance with the guidelines for vaccination by the private sector and national governments.

Anyone wishing to apply for such licenses will need to obtain three items - a new drug license from the drug regulator under the New Drugs and Clinical Trials Rules 2019; import license and registration license. No such permit is required to import Sputnik V approved by the Indian regulator for emergency use other than Covaxin and Covishield. Under the new vaccination policy that will take effect from May 1, provinces and non-governmental organizations can negotiate and obtain approved external vaccines. The new guidelines facilitate the importation of goods and state, "After obtaining an import license, the importer or authorized agent of the vaccine manufacturer may import the drug and purchase it."

On April 15 this year, the agency announced that it would expedite the immediate approval of COVID-19 vaccines already issued by the EUA Emergency Use. This allows all drugs approved by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the British Medicines and Healthcare Products Regulatory Agency (MHRA), to be marketable, in India soon. The Center also approved external vaccines included in the Emergency Use List maintained by the World Health Organization (WHO) for immediate follow-up.

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NEGVAC Decision:

The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) took this decision on April 11 as the Second Covid-19 Epidemic Wave continues to increase the number of daily cases nationwide due to a severe shortage of vaccines. The government believes that its latest move will help speed up access to foreign vaccines and lead to more imported bulk drugs, which can be used to make these vaccines locally. The institute said the efficient use of complementary and complementary products at home would be achieved as a result, with the provision of a fillip in the production capacity and full availability of vaccines. The institute said the full use of filling and finishing power at home will also be achieved and, as a result, provide fillip in the production capacity of the drug and the full availability of vaccines.

GUIDELINES FOR IMPORT OF COVID-19 VACCINE:

The new guidelines will allow any private sector or individual to import vaccines in accordance with certain conditions. The guidelines also stated that readiness to use the imported vaccine Covid "will be allowed to be used exclusively outside the Government of India", thus allowing private organizations and governments to implement the imported vaccines. However, those who want to import the Covid vaccine in India will have to follow certain procedures. These are:

1. If the vaccine has not been approved/licensed in India, the importer / authorized agent of the vaccine manufacturer will receive the following permit/license from CDSCO.

a. New Drug Permit Under New Drug Laws and Clinical Trials Rules, 2019

b. Submit registration under the Drugs Act, 1945

c. Submit a license under the Drugs Act, 1945.

2. After obtaining an import license, the importer / authorized agent may import the vaccine and any private sector business may purchase the vaccine from them as per national guidelines.

3. If the imported vaccine has already been approved and the import license has been obtained from CDSCO, then any business including private enterprise may purchase the vaccine from the importer/licensee for use in accordance with national guidelines.

Under the third phase of its vaccination strategy, manufacturers will be required to supply 50 percent of their monthly doses to the government and the rest to state governments or the open market.

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