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Indian Pediatr 2021;58: 689-690 |
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Non-availability of Parenteral Preparations
of Vitamin A: Is a Silent Surge of Bronchopulmonary Dysplasia
Happening in India?
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Shahid Akhtar Siddiqui* and Manisha Maurya
Department of Pediatrics, SN Children Hospital, MLN
Medical College, Allahabad, Uttar Pradesh.
Email:
[email protected]
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Bronchopulmonary dysplasia (BPD) continues to be one of the most
important challenges in the care of the preterm infants,
affecting approximately one-quarter of very low birth weight
infants [1]. With better availability and improved quality of
care of neonatal intensive care units (NICUs) in India, more and
more such babies are surviving. As vitamin A is accumulated
mainly in the third trimester, preterm infants may have low
vitamin A levels at birth, which may contribute to an
increased risk of developing BPD. With the large
number of preterm babies surviving, there is possibility of an
increase in number of BPD cases.
Most of randomized trials to study efficacy
of vitamin A supplementation to prevent BPD used parenteral
preparations. Globally, trials testing efficacy of oral vitamin
A supplementation in preventing BPD has not shown its role [2].
During the last few years there is increasing
difficulty in getting intramuscular preparations of vitamin A.
Thus currently virtually no vitamin A injections are available
in Indian market, making it one of latest addition in orphan
drugs. India still lacks appropriate policy framework for orphan
drugs, making a country-specific Orphan Drugs Act (ODA), need of
the hour [2]. Well-designed multicenter trials should be done in
Indian setting to study role of oral vitamin A in preventing
BPD. Until efficacy of oral vitamin A is proved, Indian Academy
of Pediatrics should engage with the government to ensure easy
availability of injection vitamin A throughout the country.
REFERENCES
1. Guimarães H, Guedes MB, Rocha G, et al.
Vitamin A in prevention of bronchopulmonary dysplasia. Curr
Pharm Des. 2012; 18: 3101-13.
2. Rakshasbhuvankar AA, Simmer K, Patole SK,
et al. Enteral vitamin A for reducing severity of
bronchopulmonary dysplasia: A randomized trial. Pediatrics.
2021;147:e2020009985.
3. Reddy DS, Pramodkumar TM, Reddy Y, et al. Orphan
regulations for orphan drug development in India. Asian J Pharm.
2014;8: 130-2.
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