China
Africa
Explore chapters and articles related to this topic
Challenges of Regulation of Medicines in India
Published in Hans Löfgren, The Politics of the Pharmaceutical Industry and Access to Medicines, 2017
There is a need for an agency in India that is independent of the office of the Drug Controller General of India (DCGI), such as the National Institute of Clinical Excellence (NICE) in the UK, to create a scientific basis for the decisions of the CDSCO/DCGI with respect to vaccines and medicines. Such an organisation could be empowered to undertake independent appraisal/comparator studies, and make market approval recommendations on new and existing medicines (and also treatments and procedures) on the basis of risks, benefits, costs and efficacy. In November 2009, NICE refused to approve sorafenib, the medicine for which India’s first compulsory licence was awarded, for use in the National Health System in UK on the basis that increasing survival in liver cancer by six months did not justify its high price—around £2,500–3,000 per patient per month.10We do not have a legally empowered organisation in India which could reject medicines on such grounds even when its advantages over existing alternatives are marginal or non-existent.
Diagnosis, prevention, and treatment of coronavirus disease: a review
Published in Expert Review of Anti-infective Therapy, 2022
Manoj Kumar Sarangi, Sasmita Padhi, Shrivardhan Dheeman, Santosh Kumar Karn, L. D. Patel, Dong Kee Yi, Sitansu Sekhar Nanda
The Government of India has approved two South Korean companies (Seegene and SD Biosensor) for supplying RT-PCR-based COVID-19 diagnostic kits. Antibody-based rapid kits have been developed by seven Chinese biotech firms: AmonMed Biotechnology Co. Ltd., Beijing Tigsun Diagnostics Co. Ltd., Getein Biotech, Hangzhou Biotest Biotech, Hunan Lituo Biotechnology Co. Ltd., Wondfo Biotech Co. Ltd., and Vivacheck Laboratories. Five different companies from the United States of America (USA), Singapore, Poland, and South Korea, namely, Bio Mednomics, CTK Biotech, Sensing Self Ltd., Biomaxima, and SD Biosensor, have received approval for the manufacture of rapid antibody testing kits for India [41]. These kits are used for early COVID-19 detection. The Indian Council of Medical Research on April 14 and the Drug Controller General of India on April 16 have granted licenses to the manufacturers [42]. The Indian company MyLab and the German firm Altona Diagnostics have supplied COVID-19 test kits to both government and private testing laboratories in India [43].
Fixed-dose combinations banned in India: is it the right decision? An eye-opening review
Published in Expert Opinion on Drug Safety, 2019
Marlon Ramcy Henry Miranda, Akhilesh Dubey, Ravi G.S, R Narayana Charyulu
The Drugs and Cosmetics Act, 1940 and Rules, 1945 regulates the drugs in India. According to the act before the independence, the central government held responsible for the import of the drugs and the state government regulated the manufacture, distribution, and sale of the drugs. After independence in 1947, both the Central and the State Governments had the power to make laws related to the drugs. According to the Drugs and Cosmetics Act, 1940 the approval is granted by the Drug Controller General of India (DCGI). Before granting approvals, the CDSCO will inspect the product concerning quality, safety, and efficacy. In 1952, the national rules introduced the concept of ‘new drug’ with the requirements before the approval of imports. After that increase in the control of the central government has occurred regularly before. However, the state government has retained its power to license the manufacturing and sale of the drugs. The 1988 amendment inserted a new part XA into the national rules entitled ‘Import or Manufacture of New Drugs for Clinical Trials or Marketing’. After September 1988, the FDCs combining for the first time and that has been approved once and will be included within the definition of ‘New Drug’ under the rule 122E (c) because of this, these FDCs will require prior approval from the central government under Rules 122B or 122C along with the evidence [20,21].
Malaria medicines to address drug resistance and support malaria elimination efforts
Published in Expert Review of Clinical Pharmacology, 2018
Jane Achan, Julia Mwesigwa, Chinagozi Precious Edwin, Umberto D’alessandro
Endoperoxide antimalarials like the artemisinins have played a major role against drug-resistant malaria [104] and the development of synthetic endoperoxides with similar or enhanced antimalarial properties and improved pharmacokinetics is promising [105]. The first clinical product of this kind was OZ277 (also known as Rbx11160 or arterolane) [106], which is one of the first fully synthetic trioxolane peroxides and a non-artemisinin antimalarial compound. It has rapid schizonticidal activity against all erythrocytic stages of P. falciparum but with no effect on hepatic stages [107]. Ranbaxy Gurgaon, Hiryama, India, has greatly advanced the clinical development of a fixed dose that consists of rapidly acting arterolane and longer acting piperaquine [103]. Clinical studies of this combination in acute uncomplicated P. falciparum malaria patients provide evidence of high clinical efficacy [108] with PCR-adjusted adequate clinical and parasitological response at day 28 of 100% with arterolane-piperaquine against 98.7% with artemether-lumefantrine [107]. This combination was recently approved by the Drug Controller General of India [109]. Additional studies in areas with artemisinin-resistant malaria are ongoing [110].