DTAB Current Affairs
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The sub-committee of Drugs Technical Advisory Board (DTAB) has recommended prohibition of 343 fixed drug combinations (FDCs) after reviewing 349 and called for regulation and restriction of remaining six. FDC means combination of two or more drugs in fixed dosage ratio.
The expert sub-committee in its reports suggested banning 343 FDCs, three should be restricted for specific indications or diseases and other three FDCs should be restricted to specific quantities of ingredients and for specific indications. It stated that for most FDCs, their use will lead to unnecessary overuse and patients will be exposed to risk of multiple ingredients when one will suffice.
In March 2016, Union Government had banned total 344 FDC on suggestion of Kokate committee, which had studied irrationality of various FDCs, recommended ban on 344 of them, citing rising “antibiotic resistance” in the country as one of reasons. Later in December 2016, Delhi High Court struck down ban stating that Government had acted in haphazard manner.
The matter then went to Supreme Court, which in December 2017 which directed health ministry’s expert body DTAB for fresh review of safety, efficacy and therapeutic justification of these 349 FDCs. It had stated that DTAB or its subcommittee will have to decide whether it is necessary in larger public interest, to regulate, restrict or prohibit manufacture, sale or distribution of such FDCs. Therefore, DTAB had formed sub-committee, which studied issue and submitted its recommendations.
Drugs Technical Advisory Board (DTAB)
DTAB is highest statutory decision-making body on technical matters related to drugs in the country . It is constituted as per the Drugs and Cosmetics Act, 1940. It is part of Central Drugs Standard Control Organization (CDSCO) in the Ministry of Health and Family Welfare.
The Union government has banned imports of hormone oxytocin to stop its misuse in livestock industry, where it causes hormonal imbalances and shortens the lives of milch animals. The Government has decided to rely on domestic production to satisfy requirements of hormone. It has asked customs officials to step up vigilance against those likely to try and smuggle oxytocin into India.
India had halted retail sales of oxytocin as prescription-only drug in 2014, but failed to curb illegal sales and the volume of imports was unclear. Even, Drug Technical Advisory Board (DTAB) in February 2018 had recommended import ban of oxytocin. It also had recommended that sale be limited to registered government hospitals and clinics and bar code system should be used on all forms of drug to ensure tracking and prevent abuse. For adopting its recommendations, DTAB proposal had proposed amendments to section 10 of Drugs and Cosmetics Act, 1940 and rule 96 of Drugs and Cosmetics Rules, 1945.
Oxytocin, often called love hormone, is released naturally in human bonding activities such as sex, childbirth and breastfeeding. It is uterine stimulant hormone, prescribed for initiation of uterine contractions and induction of labour in women as well as stimulation of contractions during labour. It is also used to help abort fetus in cases of incomplete abortion or miscarriage, and control bleeding after childbirth. It may be used for breast engorgement.
It is a controversial hormonal injection that is used widely in the dairy industry, agriculture and horticulture. The drug’s abuse in animals shortens their lives and makes them barren sooner. Even its misuse is reported among trafficked children, injected to accelerate puberty among girls. It is also being misused to speed up deliveries for pregnant women in overcrowded government hospitals.