Summary: The updation of information by CDSCO will ensure a more transparent and measurable transit of vaccines imported for testing. While obtaining the drug test license for importers is still a time-taking and tedious procedure. This is still an appreciable step in the right direction.
Biologicals are big complicated substances that are produced by making use of recombinant DNA technology. Vaccines are an immune system stimulating drugs and fall under the category of biologicals.CDSCO or the central drugs standard control organization plays a very important role in the regulation of the manufacture and import of vaccines in India.
This not only helps in making sure they are safe, efficient, and of good quality but also helps in enforcing rules on the companies that make them.
Since vaccines are an important component of the drugs and pharmaceutical industry. Their import, manufacture, and sale have to be strictly regulated and observed to ensure public health safety.
In a recent series of events, the CDL(Central Drugs Laboratory) asked all the CDSCO port offices to update their information forms concerned with the import of vaccine samples for clinical testing.
Since the information provided by the importers about the vaccines brought in India as samples were not deemed sufficient by CDL for analysis.
CDL outlined some major concerns and updates to document submissions as suggestions to CDSCO, which include:
● Details about the number of doses imported for testing. In order to facilitate proper tracking of the units being dispersed for various activities.
● Copy of release certificate from the country of origin(English translation copy to be attested with a notary public). To ensure valid and credible transfer.
● CDL will not issue the lot release certificate as per the standard format in case the batch has not been imported completely or the import quantity is not mentioned in the documents submitted.
Process for obtaining permission for testing of imported vaccine in India:
● The first step is the Phase I clinical trial that can be conducted in India or any other country-based upon where the substance was found. A detailed report of these trials must be submitted along with the respective application. These phase 1 trials should have been carried out by a trained person in 1 or 2 centers. Plus every dose should have been tried with 2 subjects for confirmation.
● After approval of the application submitted for phase I trials. The importer should conduct phase II and Phase III trials. The phase trials should be done with at least 10-12 subjects at every dose level and it should be conducted in 3-4 centers by trained experts.
● The phase III trials have to be conducted in India before consent is granted for selling it in the market. The phase III trial is done with a minimum of 1000 subjects in about3-4 centers for verification of drug safety and efficiency.