11-Dec-2020: Indigenous mRNA vaccine candidate supported by DBT gets Drug Controller nod to initiate Human clinical trials
India’s first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology of M/o Science & Technology.
The mRNA vaccines do not use the conventional model to produce immune response. Instead, mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus. The host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease. mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria. Therefore, they can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their "availability" and "accessibility" for mass vaccination on a sustainable basis.
Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate. HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19. Gennova’s vaccine candidate uses the most prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which gives the advantage of a low dosing regimen compared with the non-replicating mRNA or traditional vaccines. HGCO19 uses the adsorption chemistry so that the mRNA is attached on the surface of the nano-lipid carrier to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry.
HGCO19 is stable at 2-8°C for two months. Gennova has completed all preliminary work and should be initiating the Phase I/II Human clinical trial soon since the approval from the DCGI office has been received.
The Department of Biotechnology, Ministry of Science & Technology, Government of India is implementing the IndCEPI mission ‘India Centric Epidemic Preparedness through Rapid Vaccine Development: Supporting Indian Vaccine Development’ which is aligned with the Global Initiative of CEPI and aims to strengthen the development of vaccines and associated competencies/technologies for the diseases of epidemic potential in India. The Ind-CEPI mission of DBT is implemented by its PSU, Biotechnology Industry Research Assistance Council ( BIRAC).
‘Establishment of a such indigenous technology platform will not only empower India to handle the COVID-19 pandemic but also ensure the preparedness for future outbreaks’ said Dr Renu Swarup, Secretary, Department of Biotechnology and Chairperson BIRAC.
19-Jun-2020: After providing for enough/surplus stocks for domestic market, ban on export of HCQ lifted
Government has lifted ban on export of anti-malarial drug Hydroxychloroquine (HCQ) API and formulation. With immediate effect.
Based on inter-ministerial consultation held on 03.06.2020 by a High-Level Empowered Committee having representations from Ministry of Health and Family Welfare, Department of Pharmaceuticals, Ministry of External Affairs, Ministry of Commerce and Industry, Department of Revenue and others, department of Pharmaceuticals has recommended that ban on export of Hydroxychloroquine (API as well as formulations) may be lifted. Directorate General of Foreign Trade -DGFT has issued a formal notification in this regards yesterday.
An Inter-ministerial High-Level Empowered Committee meets regularly on fortnightly basis for assessing the availability of drugs in the country and will continue to meet to monitor the situation.
In the meeting it was noted that during March-May, 2020 period (COVID-19 period) numbers of manufacturing units of Hydroxychloroquine have increased from 2 to 12 and the country’s production capacity of Hydroxychloroquine have increased three times i.e. from 10 Crore (Approx.) tablets per month to 30 Crore (Approx.) tablets per month. Currently, India is having surplus of Hydroxychloroquine tablets over and above its domestic requirements.
It was also noted that the requirement of Ministry of Health and Family Welfare for Hydroxychloroquine has been fulfilled completely as12.22 Crore tablets of HCQ 200 mg Tablets has been given to HLL Lifecare Limited (HLL), a central public sector undertaking, for dealing with COVID-19. Presently, MoHFW is maintaining enough buffer stock of HCQ to cater to domestic demand. In addition, 7.58 Crore Tablets of HCQ 200 mg has been supplied to State Government, other Institutions and BPPI/Jan Aushadhi Kendras for fulfilment of their requirement. Further, around 10.86 Crore tablets of HCQ 200 mg has been supplied in local pharmacies for catering to the domestic demand. Thus, a total of 30.66 Crore tablets of HCQ 200 mg has been made available to domestic market to cater the demand of the country. There is no unfulfilled domestic demand for Hydroxychloroquine. Further, Major manufacturers of Hydroxychloroquine will supply at least 5 Crore tablets in the domestic market for the month of June, 2020.
Drug Controller General of India (DCGI) conducts survey regarding availability of Hydroxychloroquine and other drugs in domestic market from time to time. It was noted that in a sample survey conducted on 25th and 26th May, 2020, the availability of Hydroxychloroquine was indicated at 93.10% in Pharmacies near to COVID-19 designated hospitals.
Accordingly, it has been decided to lift the ban on export of Hydroxychloroquine (API as well as formulations). However, at the same time, Domestic producers of HCQ other than EOUs, SEZs and Units will continue to supply at least 20% tablets of total manufacturing for local pharmacies or trade, whichever is higher for the month of June, 2020. The supply made to State Governments, HLL and other public and private institutes will be over and above the quantity mentioned this quantity. Further, all manufacturers of shall fulfil any order placed by HLL, State Government(s) or any other Government Institute on priority basis. Drug Controller General of India (DCGI) has been directed to ensure compliance of these conditions.
20-Dec-2019: Afghanistan first country to recognize Indian Pharmacopoeia
The Indian Pharmacopoeia (IP) has been recognised formally by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Islamic Republic of Afghanistan. It will also be used based on the requirement as reputable pharmacopoeia in the laboratory of medicines and health products quality. With this, a new beginning has been made and Afghanistan has become the first country to recognize IP pursuant to the efforts of Department of Commerce and Ministry of Health and Family Welfare.
IP is an officially recognized book of standards as per the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder. The IP specifies the standards of drugs manufactured and marketed in India in terms of their identity, purity and strength.
The quality, efficacy and safety of the medicines are important from healthcare perspective. In order to ensure the quality of medicinal products, the legal and scientific standards are provided by Indian Pharmacopoeia Commission (IPC) in the form of Indian Pharmacopoeia (IP). As per, the Second Schedule of the Drugs and Cosmetics Act, IP is designated as the official book of standards for drugs imported and/or manufactured for sale, stock or exhibition for sale or distribution in India.
The IP Commission’s mission is to promote public and animal health in India by bringing out authoritative and officially accepted standards for quality of drugs including active pharmaceutical ingredients, excipients and dosage forms, used by health professionals, patients and consumers. This is achieved by developing the standards for medicines and supporting their implementation. In addition, IPC also develops IP Reference Substances (IPRS) that act as fingerprint for identification of an article under test and its purity as prescribed in the IP monographs. Standards prescribed in the IP are authoritative in nature and are enforced by the regulatory authorities for quality control of medicines in India.