Clinical Trial Process For Drugs In India
Clinical Trial Process For Drugs In India
The Covid-19 emergency has propelled a race for preventive vaccines and treatment, with numerous efforts by companies, commercial consortia, and scientific organizations worldwide.
India is a hub for vaccine production and produces 60 percent of the world's vaccines. Indian companies have played a pivotal role in producing and distributing vaccines worldwide through organizations like UNICEF, Gavi, and WHO.
Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, has announced to fast-track the regulatory approval process for vaccines, diagnostics, prophylactics, and therapeutics designed to prevent or treat COVID-19.
As part of an effort to provide quick access to vaccines and drugs to manage COVID-19, the CDSCO is creating a dedicated coronavirus unit to address inquiries on the development of these products. As per the CDSCO notification:
Any firm or research institute with a protocol for repurposing existing drugs/vaccines for the treatment of COVID-19 will be given priority for review and approval.
Applications for clinical trial permission and application to import or manufacture drugs or vaccines for sales and distribution would be processed on priority through expedited review and accelerated approval.
CDSCO will also be expediting reviews and approvals for drugs and vaccines already approved in other countries. As per this measure, any firm having a drug or vaccine already approved for COVID-19 in any other country can directly approach the Drugs Controller General of India (DCGI) for expedited review and accelerated approval. This step will help reduce the time for crucial drugs and vaccines to reach the market.
On a case-by-case basis, CDSCO may agree to abbreviate, defer, or waive the need for developers of drugs and vaccines to generate animal toxicity, clinical, stability, and other types of data related to COVID-19.
CDSCO also plans to process applications to manufacture or import COVID – 19 drugs or vaccines for test, analysis, or clinical trial within seven days.
The leading companies working towards developing a COVID-19 vaccine are Serum Institute of India, Bharat Biotech, and Zydus Cadila.
Serum Institute of India, a pioneer in vaccine development, has collaborated with Codagenix, an American biotech company, to develop a "live attenuated" vaccine. The vaccine candidate, developed using synthetic lab-made coronavirus using Codagenix's deoptimization technology, is in the preclinical stage. The vaccine is expected to enter human clinical trials in the coming months and be market-ready by early 2022.
Bharat Biotech has partnered with the University of Wisconsin Madison and US-based firm FluGen to develop a unique vaccine against COVID-19 called CoroFlu. CoroFlu will be developed on the backbone of FluGen's flu vaccine candidate known as M2SR.
Zydus Cadila is working on two vaccine approaches - the first approach includes the development of a DNA vaccine against the viral membrane protein of the virus, while a live attenuated recombinant measles virus (rMV) vectored vaccine will be developed in the second approach.
Premas Biotech, a company that specializes in creating recombinant protein for vaccine development, has out-licensed its vaccine candidate to Akers Biosciences Inc, USA. As per Premas Biotech, these recombinant proteins target the three proteins on the SARS-CoV-2 virus: the spike protein, envelope protein, and membrane protein. The ability to target all three offers a strong case for the vaccine.
Other Indian companies in the COVID-19 vaccine landscape include Biological E, Indian Immunologicals, Mynvax, Auro Vaccines, and Gennova Biopharmaceuticals.
As countries across the world look forward to the development of both preventive vaccines and treatment for Covid-19, the challenges of access and scaling up of manufacturing capacities for delivering therapies to millions of people cannot be overlooked. With the world collaborating to find a viable vaccine for Covid-19, high hopes set on India - the powerhouse of vaccine manufacturing.
Enabling large scale manufacturing, advancing rapid regulatory reforms and collective action can help deliver the appropriate vaccine at the right time to the right person. References
When ready, a coronavirus vaccine must reach all. https://www.natureasia.com/en/nindia/article/10.1038/nindia.2020.81
Indian manufacturers account for 60% of vaccine supplies made to UNICEF. 2017. BioSpectrum. Asia Edition. Available at: https://www.biospectrumasia.com/opinion/37/9356/indian-manufacturers-account-for-60-of-vaccine-supplies-made-to-unicef.html. Accessed on: 23 May 2020.