How to Register and Get CDSCO Licensing During the Pandemic?
India has been rapidly racing towards becoming one of the biggest hubs for pharmaceutical supplies and other medical facilities. As the scope of the sector is widening, the government keeps it at the top of their priority list to maintain a robust regulatory mechanism to track each step from production to trade.
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The manufacturing, import, distribution and sale of medical devices and drugs is monitored through the Drug and Cosmetics Rules, 1945, Drugs and Cosmetics Act, 1940, as well as the Medical Devices Rules, 2017. In addition, the responsibility of registration for both medical devices and drugs has been invested in the Central Drug Standards Control Organisation, a crucial working organ of the Directorate General of Health Services, Ministry of Health and Family Welfare.
Regulatory requirements to import medical devices through Indian borders
To carry out any kind of trade in both medical devices as well as pharmaceutical drugs, it is a requirement to obtain a permit certificate from the CDSCO. So far, the CDSCO has permitted only specific medical devices to be produced, sold, distributed and imported. These devices have been listed as the ‘notified devices’ by the department. However, many medical devices are yet to be added to the list and are, to date, classified as ‘drugs’, and therefore, need regulatory approval.
In India, the first step to gaining an import license for medical devices is to file an application to the CDSCO in the format prescribed by it. This, if approved, would be a governmental nod for obtaining an import license and a registration certificate. This certificate is usually released 9 months after applying, including the registration fee and the correct documentation. This registration certificate is valid for exactly 3 years. It can be renewed afterwards.
Government relaxations in the Times of COVID-19
In today’s time, when COVID-19 has taken over the world, the government has been encouraging development and research in the field of medical sciences, which could help tackle it. As a step towards the same, the CDSCO has given many relaxations, keeping on priority the applications that have drugs or medical devices which are being developed for the coronavirus. In addition, CDSCO import license registration has been made easier to facilitate in tough times.
The CDSCO has given the following guidelines:
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Drug Controller General of India can directly be reached by any applicant with a drug or medical device developed to tackle COVID-19. This is done to ease the regulatory path.
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Any drugs or medical devices that already have approval for it to be used by any foreign government can be taken for a rapid consent process by the CDSCO.
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All applications filed for devices that are to be imported or manufactured for testing and evaluation can be processed within a week and are kept on priority.
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Applications seeking permission to produce or import drugs or vaccines for testing and analysis or clinical trials can be processed in a week.
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Applications seeking permission to evaluate performance would be kept on priority and looked at an accelerated pace of the procedure.
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Any research institution or firm which presents a systematic plan for repurposing the already existing drugs or vaccines for COVID-19 would be kept on priority for approval and review.
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Applications seeking permission to conduct clinical trials would also be given priority and will be processed very quickly.
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If there is an urgent need, a CDSCO import license would be provided even without a registration certificate. However, it would require a permit from the Centre Government.
The Indian Council of Medical Research has taken a step to encourage rapid COVID-19 testing. The method of testing recommended by the ICMR is the RT-PCR for private laboratories as well as government hospitals/laboratories. To facilitate the government plans of rapid testing, the ICMR has designed a proper mechanism at the National Institute of Virology, Pune. This modified process would allow fast approval of testing kits.
The need to get approval from the DCGI has been lifted for the COVID-19 testing kits. This was done to curb the problems created by the limited medical testing facilities as well as the costly testing kits. This is, however, primarily for the types of equipment that are developed by indigenous firms.
Patentability of medical devices and testing kits for COVID-19
Any new invention in testing kits and medical devices could be held up for parenting in India. COVID-19 testing kits developed all around the world can be registered for patenting in India.
For more detailed information, contact us at Operon Strategist.
