Manas Dasgupta
NEW DELHI, May 8: As India surpassed four lakh mark recording 4.01 lakh new Covid cases in the last 24 hours till Saturday morning, a new drug administered orally developed in the country after a year of experiments and trials as adjunct therapy in moderate to severe Corona patients has been approved for emergency use by the Drugs Controller General of India (DCGI), the government announced on Saturday.
Battling against the unprecedented surge, the government in a bid to provide better healthcare facilities to the affected, has also brought relaxations on hospital admissions and said positive coronavirus disease (Covid-19) report was no more mandatory for admission to Covid-19 hospitals.
The union health ministry took the decision to ensure that no patient is denied adequate medical care as the nation fights a severe second wave of Covid-19. The health ministry in a statement also reiterated that admission to the patient should not be refused at any count even if the patient belongs to a different city and adequate medical arrangements, such as oxygen or essential drugs, should be administered to the patient.
On the oral drug, the government said clinical trials of the drug 2-deoxy-D-glucose (2-DG) showed that it helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence.
The drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO), in collaboration with Dr Reddy’s Laboratories in Hyderabad.
Announcing the DCGI’s decision, the defence ministry said the Phase III clinical trial results have shown that this molecule helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed RT-PCR negative conversion in patients infected with coronavirus.
Responding to Prime Minister Narendra Modi’s call for preparedness against the pandemic, the DRDO took the initiative of developing anti-Covid therapeutic application of 2-DG. In April 2020, when the first wave of pandemic struck India, scientists at DRDO’s laboratory, Inmas, conducted experiments with the help of Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, the DCGI’s Central Drugs Standard Control Organisation (CDSCO) permitted Phase-II clinical trial of 2-DG in Covid-19 patients in May 2020.
DRDO along with its industry partner Dr Reddy’s Laboratories started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients.
“In Phase-II trials (including dose ranging) conducted between May and October 2020, the drug was found to be safe in Covid-19 patients, and showed significant improvement in their recovery. Phase IIa was conducted in 6 hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients. In efficacy trends, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints. A significantly favourable trend (2.5 days difference) was seen in terms of the median time to achieving normalization of specific vital signs parameters when compared to SOC,” a top DRDO official said on Saturday.
The official further said based on successful results, the DCGI then permitted the phase III of clinical trials in November 2020. It was conducted on 220 patients between December 2020 and March 2021 at 27 Covid-19 hospitals across Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
“The detailed data of phase-III clinical trial was presented to DCGI. In 2-DG arm significantly higher proportion of patients improved symptomatically and became free from supplemental oxygen dependence (42% vs 31%) by Day-3 in comparison to SOC, indicating an early relief from Oxygen therapy or dependence. The similar trend was observed in patients more than 65 years also,” the DRDO official said.
The DCGI had on May 1 granted permission for emergency use of the drug as adjunct therapy in moderate to severe Covid-19 patients. Being a generic molecule and analogue of glucose, it can be easily produced and made available in plenty in the country, the DRDO said.
The drug comes in sachet in the form of powder which is taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. The selective accumulation in virally infected cells makes this drug unique.
At a time when the second wave of the coronavirus pandemic hammers the country and a large number of patients are requiring severe oxygen dependency and hospitalisation, the drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of Covid-19 patients and burden on health infrastructure of the country, the government claimed.
Meanwhile, the health ministry announcing the norms of hospital admissions said a suspect case of Covid-19 should be kept in the suspect ward of the Covid-19 Care Center (CCC), Dedicated Covid-19 Health Centre (DCHC) or Dedicated Covid-19 Hospital (DCH). It also asked hospitals to not demand valid identity card that does not belong to the city where the hospital is located for admitting the patient.
“Admissions to hospital must be based on need. It should be ensured that beds are not occupied by persons who do not need hospitalization,” the statement said. The statement said these new rules are applicable to all government as well as private hospitals. “This patient-centric measure aims to ensure prompt, effective and comprehensive treatment of patients suffering from Covid-19,” the statement said.
The ministry has asked chief secretaries of states and Union Territories to issue necessary orders and circulars and asked them to implement the new rules within the next three days.
Meanwhile, the Prime Minister on Saturday spoke to Maharashtra Chief Minister Uddhav Thackeray, Himachal CM Jai Ram Thakur, MP CM Shivraj Chouhan and Tamil Nadu CM MK Stalin on the coronavirus situation in their states. Modi has been interacting with chief ministers over telephone for the last couple of days to take stock of the pandemic situation.
Urging the Centre to provide more vaccines to Delhi, Chief Minister Arvind Kejriwal said the national capital has only 5-6 days of vaccinations left as around “1 lakh people” are getting vaccinated daily. Kejriwal also said that the capital can finish its vaccination drive within 3 months if Centre provides it with 80-85 lakh doses each month.
India recorded over 4 lakh new Covid-19 cases in the last 24 hours ending 8 am Saturday, taking the country’s total caseload to over 2.18 crore. Out of these, over 37 lakh cases are currently active while over 1.79 crore people have recovered. With 4,187 new deaths, the toll now stands at over 2.38 lakh. At least 14 states are reporting cases in five figures. Maharashtra reported about 54,000 cases, Karnataka had nearly 49,000, while Kerala had over 38,000.
Meanwhile, Sri Lanka claimed on Saturday that it detected its first case of the Indian variant of coronavirus, also known as B.1.617, in a person who recently returned from India and was in a quarantine centre here.
The Department of Immunology and Molecular Medicine of the University of Sri Jayewardenapura here in a report released on Saturday said the infected person had returned from India and was found at a quarantine center for returnees in Colombo.
The sample was among several other samples obtained for testing until April 30, the Colombo Gazette reported.