Here is a round-up of all the potential candidates put forward by Indian firms, that can help us in this fight against the ongoing Covid-19 pandemic. How many Indian firms are getting approvals for medicines and testing kits? Does India have the potential to reduce dependency on China for Active Pharmaceutical Ingredients?
Crux of the Matter
Covid-19 Antigen Rapid Testing Kit
Mylab Discovery Solutions has become the first Indian firm to have received commercial approval from the Indian Council of Medical Research (ICMR). It had officially announced its ‘Pathocatch’ Covid-19 antigen rapid testing kits earlier this week.
It is one of three suppliers of such kits, the other two being South Korea-based SD Biosensor and Belgium-based Coris Bioconcept. Mylab antigen test cost ₹450 per unit while its RT-PCR test kits are ₹1,000 per unit.
SII Testing Kit
Pune-based Serum Institute of India (SII) along with Mylabs has launched testing kits to detect Covid-19 by increasing the test rate.
As per SII CEO Adar Poonawalla, Automated Molecular Covid Test Machine minimises human interaction and reduces time by conducting 32 tests per hour.
SII is the world’s largest manufacturer of vaccines by volume as it produces 1.5 billion+ doses every year. Oxford-AstraZeneca will together conduct experimental testing in India, in collaboration with SII. Study findings of the phase 3 trials found out last week that the vaccine, named, AZD1222 is safe and immunogenic.
Zydus In Vaccine Race
Zydus Cadila has started clinical trials of its Covid-19 vaccine ZyCoV-D, with the first human dosing. It is looking to complete the clinical trials in seven months. After completing phase 1 and phase 2 in the next 3 months, they will submit the data to the regulator who will analyse the study finding and give a thumbs up.
Indian Pharmaceutical Biocon suffered a setback earlier this week, as the Union health ministry announced that the firm’s itolizumab drug is not part of the national treatment protocol for Covid-19.
They cited “very less evidence in favour of this medicine.” Several independent experts additionally questioned their use of just 30 patients for the trial. In defense, Biocon noted that it is a drug that was approved previously for psoriasis, and this was only a label extension.
Overall Global Statistics
As per WHO, 25 candidate vaccines are in one of the three stages of human trials. These include Indian companies, Zydus and Bharat Biotech. As of the date of publishing this, another 139 are in pre-clinical evaluation i e still being tried out on animals.
US-based Moderna Therapeutics was the earliest mover, with it entering phase-III trials, and 30,000 volunteers have been roped in for the same. Some are injected with the real vaccine and others are given fake ones, wherein the researchers expect to see a lower infection rate in the former. Then, in the subsequent weeks, it will be seen whether they have been infected or not. It is being hoped to be completed by October 2022.
Indian API Firms Gain As China Loses Some More
India’s Active Pharmaceutical Ingredients (API) firms have reported increased interest from worldwide customers due to nations wanting to lessen their dependency on China. This is great news because we have the world’s highest number of USFDA Approved API facilities, making it a critical part of the global supply chain.
India has an import reliance of 63% of bulk drugs, costing $34 billion which would have to be lowered in the long term. Currently, the government has announced a scheme of ₹7000 crores to promote key API firms.
- Point-of-care testing is defined as medical diagnostic testing at or near the point of care, at the time and place of patient care. This contrasts with the historical pattern in which testing was wholly or mostly confined to the medical laboratory, which entailed sending off specimens away from the point of care and then waiting hours or days to learn the results.
- OraQuick is an at-home HIV test manufactured by Orasure Technologies in 2012. It is one of the two at-home HIV tests available with the other one named Home Access HIV-1 Test System. The test results can either be invalid, positive, or negative.
- In medicine and statistics, a gold standard test is usually the diagnostic test or benchmark that is the best available under reasonable conditions. Other times, a gold standard is the most accurate test possible without restrictions.
- Live Mint – Mylab gets commercial approval from ICMR for Covid-19 antigen rapid testing kit
- India Today – Mylabs, Serum Institute launch automated Covid test, claim can conduct 32 tests/hr
- The Hindustan Times – Zydus looks to complete clinical trials of vaccine in seven months
- The Indian Express – Covid-19 vaccine tracker, July 28