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The Regulatory Dilemma for Import of Radiopharmaceuticals in India


Affiliations
1 I.K. Gujral Punjab Technical University, Jalandhar 144 603, India
2 Raja Ramanna Fellow, BARC, Radiation Medicine Centre and BRIT, Mumbai 400 012, India
3 Maharaja Ranjit Singh Punjab Technical University, Bathinda 151 001, India
4 Shivalik College of Pharmacy, Nangal, District Rupnagar 140 126,, India
5 Saveetha Institute of Medical and Technical Sciences, Chennai 602 105, India
 

The inclusion of monographs of several radiopharmaceuticals in the Indian Pharmacopoeia has drawn the attention of drug control authorities in the country and other stakeholders. Therefore, in a move towards better regulation of radiopharmaceuticals, the Office of the Drug Controller General of India has issued some important notices concerning their import. However, these notices have resulted in several misgivings among the nuclear medicine community as appointment of patients for nuclear medicine scans had to be cancelled/rescheduled and clinical decisions delayed. An analysis of the sequence of events is presented in this study, highlighting the effects of decisions taken regarding import of radiopharmaceuticals, and suggestions to implement regulations with minimal repercussions.
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  • File No. 29/Misc./4/2016-DC (101), Director General of Health Services (DGHS), Central Drugs Standard Control Organization, Government of India (GoI), 29 December 2016; http://www.cdsco.nic.in/writereaddata/Notice%20Radio-Pharmaceutical.pdf (accessed on 15 December 2018).

  • File No. DCG (I)/Misc/2017 (11), DGHS, Office of Drug Controller General (India), Import and Registration Division, GoI, 20 February 2017; http://www.cdsco.nic.in/writereaddata/radiopharma.pdf (accessed on 15 December 2018).

  • DCG (I) Misc/2017 (21), DGHS, Ministry of Health and Family Welfare, Drug Controller General (I), GoI, 20 February 2017; http://www.cdsco.nic.in/writereaddata/notice-20_2_2017.pdf (accessed on 15 December 2018).

  • File No. DCG (I)/Misc/2017 (11); DGHS, Office of Drug Controller General (India), Import and Registration Division, GoI, 28 April 2017; http://www.cdsco.nic.in/write-readdata/Radiopharmaceutical%20Order.pdf (accessed on 15 December 2018).

  • File No. DCG (I)/Misc/2017 (11), DGHS, Office of Drug Controller General (India), Import and Registration Division, GoI, 1 May 2017; https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NDc2 (accessed on 15 December 2018).

  • MoFHW, Indian Pharmacopoeia, Ministry of Health and Family Welfare, GoI, 2018.

  • Minutes of the 78th Meeting of Drugs Technical Advisory Board, New Delhi, 12 February 2018; http://www.cdsco.nic.in/writereaddata/Minutes%20of%2078th%20DTAB%20Meeting%20held%20on%2012_02_2018.pdf (accessed on 15 December 2018).


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  • The Regulatory Dilemma for Import of Radiopharmaceuticals in India

Abstract Views: 256  |  PDF Views: 74

Authors

Sandeep Sharma
I.K. Gujral Punjab Technical University, Jalandhar 144 603, India
M. G. R. Rajan
Raja Ramanna Fellow, BARC, Radiation Medicine Centre and BRIT, Mumbai 400 012, India
Ashish Baldi
Maharaja Ranjit Singh Punjab Technical University, Bathinda 151 001, India
Rajesh Kumar Singh
Shivalik College of Pharmacy, Nangal, District Rupnagar 140 126,, India
Rakesh Kumar Sharma
Saveetha Institute of Medical and Technical Sciences, Chennai 602 105, India

Abstract


The inclusion of monographs of several radiopharmaceuticals in the Indian Pharmacopoeia has drawn the attention of drug control authorities in the country and other stakeholders. Therefore, in a move towards better regulation of radiopharmaceuticals, the Office of the Drug Controller General of India has issued some important notices concerning their import. However, these notices have resulted in several misgivings among the nuclear medicine community as appointment of patients for nuclear medicine scans had to be cancelled/rescheduled and clinical decisions delayed. An analysis of the sequence of events is presented in this study, highlighting the effects of decisions taken regarding import of radiopharmaceuticals, and suggestions to implement regulations with minimal repercussions.

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DOI: https://doi.org/10.18520/cs%2Fv116%2Fi11%2F1787-1789