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Kandarp Vanita
| Updated: 04 Mar, 2021 | Category: Drug License

CDSCO Responds to COVID-19 with New Approval, Import, & Safety Measures

CDSCO on New Approval, Import, & Safety Measures

The national regulatory body under Ministry of Health and Family Welfare for pharmaceuticals and medical devices in India is the Central Drugs Standard Control Organisation (CDSCO). Since the outbreak of Covid -19 pandemic the Central Drugs Standard Control Organisation (CDSCO) on covid- 19 had released numerous notices since mid of March in order to address the pandemic. CDSCO on covid-19 response has come up with new approval and import regulations and other safety measures.

The purpose of the CDSCO is to address these new measures to accelerate the access to devices that are intended to treat or prevent the spread of corona virus and to safeguard the supply of other essentials like In-Vitro Diagnostic (IVDs), use of drug license and also to lessen the exposure of the staffs of CDSCO to the SARS-CoV-2 virus.

CDSCO on Covid-19 Response to New Approval and Safety Measures

There are numbers of responses made by the CDSCO on the new approval and safety measures, which are as follows:-

CDSCO on Covid-19 Response to New Approval and Safety Measures

Emergency Utilisation of ‘remdesivir’

The CDSCO on COVID-19 has responded with the outbreak of the pandemic and has granted consent for the emergency utilisation of remdesivir to treat patients of novel Coronavirus disease (COVID-19).

Notwithstanding, the Union Ministry of Health and Family Welfare (MoHFW), in a meeting on June 2, 2020, couldn’t share the evidence or the proof based on which this approval was conceded.

COVID-19 IVD Test Kits

The CDSCO on Covid-19 has announced that it will prioritize the use of COVID-19 IVD test kits for expediting approval on the outbreak of pandemic.

Read our article:How to Obtain Drug License in India?

Manufacturers seek supervision from DCGI

Manufacturers of the market are also encouraged to talk to the Drugs Controller General of India (DCGI) as they have already got the consent for an IVD and this discussion can result in getting fast-track approval.  

Furthermore, these manufacturers who are working for the improvement of new IVDs may make contact with the DCGI directly to request for supervision on the appropriate regulatory pathway in accordance with the guidelines of CDSCO on covid-19.

CDSCO on Regulatory Approval Process

An additional notice as has been published by the CDSCO that contains all the information and the decision to expedite the approval of the regulatory process for vaccines, prophylactics, diagnostics, and the therapeutics that is designed to prevent or treat the COVID-19 pandemic.​ As part of this programme, the CDSCO on covid-19 is creating an enthusiastic corona virus unit to deal with the inquiries on the development and improvement of these products.

CDSCO on COVID-19 Vaccine

As part of the program for speedy response to handle COVID-19 regulatory framework there shall be covid-19 vaccines, and the CDSCO of India states that it is in a view point to consider the data generated outside the country and to otherwise development to cut short the time it takes to access the vaccine.

In accordance with the rules, only after obtaining the undertaking from the importers the import of such drugs may be permitted by the port officers of CDSCO and that they have to ensure that the drug shall be consumed before the expiry date and no part of the drug shall be accessible for distribution and sale after its expiry date. This was informed by the CDSCO by a circular issued to all port offices.

The health ministry has instructed to take various steps and the India’s CDSCO on COVID-19 outbreak has responded to the pandemic accordingly, to make sure the accessibility of an adequate quantity of drugs in the domestic market. Moreover, it is important of the CDSCO to confirm that the products and drugs are complying with the prescribed specification. The Drug Controller General of India (DCGI) has stated that one of the major steps is to immediately issue approvals to the registration applications and the process of manufacture and import of pharma.

CDSCO 0n COVID-19 and Release of Critical Imported IVDs

The CDSCO on covid-19 has issued procedures for temporary modified release and for other critical imported IVDs which shall also include the HIV[1] and HBsAG test kits that are required to be followed all through the duration of the COVID-19 pandemic which has lead to cause interruption in the testing and sampling processes.

The CDSCO on covid-19 pandemic has advised the port offices that hold the consignments of the IVDs to only discharge them on the basis of reviewing of the documents, protocols, the manufacturer’s certification of release, and the compliance history. Nevertheless, it is necessary for the importers to preserve a “sufficient amount” of IVDs for future examination and to make an assurance to call back all the products that fails the laboratory tests in future.

Two notices were issued by the CDSCO on covid-19 in April 2020 for medical devices and drugs correspondingly, which stated that an applicant for import registration may submit his applications together with the required documents which should be self-attested and with an undertaking that they shall submit the notarized or the apostilled documents once the corona situation becomes normal.

The CDSCO shall on such condition process the application and if satisfied with the compliance of requirements can also issue the licenses with the prior condition for the applicant to submit the notarized or apostilled documents with time.

Disease Prevention Policies for CDSCO Employees on covid-19

  • The last notice issued by the CDSCO talks about the measures that should be strictly followed in the workplace with the intention to lessen the government staffs exposure to the SARS-CoV-2 virus.
Disease Prevention Policies for CDSCO Employees on covid-19
  • Companies that are dealing with the CDSCO are expected and motivated to make online contact through the telephone or e-mail whenever it is possible as a substitute of entering its facilities.
  •  Staff members in CDSCO offices are strictly advised to follow the suggested​practice for washing their hands, to maintain the proper hygiene, and to wear masks.
  • The CDSCO on covid-19 shall distribute the official documents that shall have all the guidelines regarding the signage in CDSCO facilities which shall mention the “dos and don’ts” for COVID-19 prevention and shall include documents such as approvals and clarification letters to be sent through an e-mail until further notice.

Conclusion

The CDSCO on COVID-19 pandemic outbreak has come up with regulations responding to the required measures that should be followed to mitigate the cause.

The health ministry has instructed to take various different measures for the purpose to make sure the accessibility of an adequate quantity of drugs in the domestic market which shall abide by the CDSCO regulations. Therefore, it is mandatory to oblige with the regulations of CDSCO on respond to covid-19 pandemic.

Read our article:Legal Obligation under CDSCO for Obtaining Wholesale Drug License

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Kandarp Vanita

Kandarp Vanita has done masters in Corporate and Commercial Law from WB National University of Juridical Sciences. She has 3 yrs of experience in drafting legal documents & dissertations. Being a curious reader, she is also passionately into providing legal backups and comprehensive understandings in every aspect of Law to the firms.

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