NEED FOR IMPORT OF MEDICAL EQUIPMENTS IN COVID-19 OUTBREAK
COVID-19 also known as the coronavirus disease is an infectious disease caused by a newly discovered virus (COVID-19). People who were suffering with the virus have symptoms like mild fever, dry cough and shortness of breath. Most people experience mild to moderate respiratory illness and recover from this disease without any special treatment. However, People with low immunity and those with underlying health issues such as cardiovascular respiratory disease, etc. are might develop serious illness.
It’s a communicable disease and can spread:
This virus can spread through touching, sneezing, coughing. In short, its highly communicable diseases can be transmitted through contact or through the mode of air, water, and soil.
What is the need for the import of medical supplies, medical gear, and medical equipment?
Coronavirus has been declared an international emergency and a Pandemic by the WHO (World Health Organisation) In order to fight with this epidemic our country health system is working continuously with high dedication but as the number of cases is increasing day by day, our health care system is facing scarcity of medical equipment and to fulfill this shortage they need to import from another country.
Our country and government are doing everything possible to control this outbreak. We need to take note that India is a country with large masses of the population. Hence, our country needs to maintain a large stock of medical supplies and equipment in order to meet the needs in case the controlling strategies do not work as planned.
India wants 1 million coveralls and goggles, 4 million N-95 masks, 2 million nitrile gloves, 600,000 face shields and 2 million triple-layer surgical masks among other items, according to the March 24 tender document, which ET has seen.
Designated Authorities and Departments for Import of Medical Equipments in India
Central Drug Standard Regulation Organization (CDSCO) in India currently controls the import or export of medical devices, which is a part of the Ministry of Health and Family Welfare.
By the Drug and Cosmetic Act 1940 and Rules 1945, all acts relating to medical devices (including their import, manufacture, sale, distribution and export) are set in motion. The Drug and Cosmetic (amendment) Bill 2013 directs us to the same via the new change concerned.
Registration with regional licensing authority is a requirement for the importation and exportation of products. Without meeting the prerequisites, the customs do not allow goods to be cleared, until they do so.
Point to reminisce while importing Medical Equipment and supplies:
The import policy provides us with the Harmonized Good Codes list of products. Classification of Indian Trade (ITC)-Harmonized Scheme (HS) has categorized products into-
Restricted – It can only be imported after the applicable regional authority has issued an import permit.
Canalized – These are the products that can only be imported using different transport procedures or methods and can only be imported through channeling agencies.
Forbidden-For example, these are strictly prohibited on all import channels in India-wild animals, oils of animal origin.
Goods not listed in the above categories can be imported freely without any limitation, only if the importer has a valid IEC and other documents required.
The importer must list all the information such as the correct products, number or grade, size, weight and quantity, delivery time and process, packaging system, etc.
Import License and Quota Procurement:
The import trade in India is regulated by the Imports and Exports (Control) Act, 1947. A person or a corporation can only import with a valid import license.
Obtaining Foreign Exchange:
As the importer only has to pay in the exporting country's currency once the IEC is issued, the next step is to arrange the foreign exchange.
Forward letter of credit:
To ensure that there is no chance of non-payment, the exporter requests the importers to give him a letter of credit for this reason.
Having required documents Customs formalities and goods clearing
In India, there are several products requiring registration including spinal needles, heart valve, annuloplasty tubes, syringes, and so on. Any business that is willing to import any such devices must comply with the Drugs and Cosmetic Act 1940 and CDSCO Regulation 1945 law.
These are the documents to be filled out to register and import an unregistered medical device –
➲Form 41: it is a certificate of registration issued under Rule 27
➲ Import license (Form 10)
➲ TR-6 Challan approval
➲ Schedule DI
➲ Schedule DII
➲ Power of attorney
➲ Free selling certificate
➲ Valid wholesale authorization/manufacturing authorization
➲ Copies of quality certification
➲ Device master file
➲ Plant master file
➲ FU and Pack insets of devices
➲ Device label
Re-registration form 44 is required in compliance with Rule 24A, 25B, 27A, and 28A of the Drug and Cosmetic Regulations. A copy of the registration certificate must be sent, along with the form 41.