Fixed dose drug combinations: Issues and challenges in India
- PMID: 27756941
- PMCID: PMC4980918
- DOI: 10.4103/0253-7613.186200
Fixed dose drug combinations: Issues and challenges in India
References
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- CDSCO. Policy Guidelines for the Approval of Fixed Dose Combinations (FDCs) in India. 2013. [Last accessed on 2016 Jun 18]. Available from: http://www.mohfw.nic.in/WriteReadData/l892s/6404452866Kokate%20Report.pdf .
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- CDSCO. Report of Expert Committee on Fixed Dose Combinations (FDCs) Licensed by SLAs for Manufacture without Approval of DCG (I), Applications of Which Received by CDSCO. 2015. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/fdcexpert%2019.1.2016.pdf .
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- CDSCO. Department-Related Parliamentary Standing Committee on Health and Family Welfare Fifty-Ninth Report on the Functioning of the Central Drugs Standard Control Organization (CDSCO) 2012. [Last accessed on 2016 Jun 18]. Available from: http://www. 164.100.47.5/newcommittee/reports/englishcommittees/committe... .
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- CDSCO. Letter Dated 15.01.2013 on Approval of Safety and Efficacy of Fixed Dose Combinations Permitted for Manufacture of Sale in the Country without Due Approval from DCGI. 2013. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/Approval_of_the_safety_and_efficac... .
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- CDSCO. Report of Expert Committee on Evaluation of Cases of Fixed Dose Combinations (FDCs) Considered as Irrational and Where Showcause Notices were Issued to the Applicants to Submit Their Replies. 2016. [Last accessed on 2016 Jun 18]. Available from: http://www.cdsco.nic.in/writereaddata/fdcreport10_2_2016.pdf .
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