Earlier this week, the Centre announced it would fast-track emergency approvals for foreign-produced Covid-19 vaccines that have already been granted Emergency Use Authorisation (EUA) in other countries.
This allowed all vaccines currently approved by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) to be potentially sold in India soon.
The Centre has also allowed foreign vaccines that are included in the Emergency Use Listing maintained by the World Health Organization (WHO) to be fast-tracked.
The National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) took the decision on April 11 as the second wave of the Covid-19 pandemic continued to push up the number of daily cases nationwide amidst a severe shortage of vaccines.
The government believes its latest move will facilitate quicker access to such foreign vaccines and also lead to more imports of bulk drug material, which can be used to manufacture the vaccines locally. The Centre said optimal utilisation of domestic fill-and-finish capacity will also be achieved as a result, in turn providing a fillip to vaccine manufacturing capacity and total vaccine availability.
But applications by drug companies being fast-tracked does not mean the number of existing steps has been cut down. Instead, on April 15 the government announced Regulatory Pathways for foreign-produced Covid-19 Vaccines, which will determine how long it will take for foreign vaccines to finally be jabbed in Indian arms.
What are the basic requirements for approval ?
The foreign company would have to agree to its vaccine being used as per the guidelines of the National Covid-19 Vaccination Program. The government will also assess the first 100 beneficiaries of such vaccines for safety outcomes before a further rollout. Most importantly, after receiving approval, applicants would have to start a bridging trial within 30 days. Bridging trials are mandated by Indian law and involve testing the vaccine among Indian participants to assess safety and immunogenecity in the local population.
Step 1: The application process
Foreign companies would have to adhere to detailed guidelines laid down by the Central Drugs Standards Control Organisation (CDSCO) and apply to the body. An application can also be made by the foreign manufacturer through its Indian subsidiary or through its authorised agent in India, in case it does not have an Indian subsidiary. Applications will also have to be accompanied by the bridging trial protocol, application for an import registration certificate and application for an import licence.
Step 2: The approval
The government has said that the CDSCO will process applications within three working days. Immediately after, the Drugs Controller General of India (DCGI), who heads the CDSCO, will greenlight the three critical legal certificates needed by foreign companies to start sending vaccines to India commercially. These include the registration certificate for an overseas manufacturing site where the vaccine is produced, the certificate for the vaccine itself, and the import licence.
Step 3: Vaccination of control group
As per the existing CDSCO protocol for batch release of vaccines, each batch will be released by the Central Drugs Laboratory at Kasauli before it can be used, as per guidelines prescribed under the National Covid-19 vaccination programme. Post this, the applicant will use the vaccine initially only on 100 beneficiaries and submit safety data to the CDSCO. The CDSCO will review this safety data and, if found satisfactory, authorise the applicant to use the vaccine in the wider population.
Step 4: Wider rollout
Even as the vaccine is commercially made available to Indians across the country, the company will continue to discuss the details of the bridging trial it will soon have to begin in India. Again, CDSCO has assured that it will approve the protocol for the bridging trial in consultation with the Subject Expert Committee within seven days of the receipt of the proposal. The applicant will have to begin the trial within the first 30 days of approval, and submit data generated in the bridging trial to the CDSCO.
Step 5: Final decision
After receiving the data, the DCGI will again review the emergency approval and take a final decision on whether to modify or suspend the permission given to the foreign company.