Drugs Technical Advisory Board Current Affairs

DTAB sub-committee recommends banning 343 fixed drug combinations

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.

Key Facts

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.

Background

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.

Month: Categories: India Current Affairs 2018

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Health Ministry bans over-the-counter sale of 14 steroid creams

The Union Health and Family Welfare Ministry has banned over-the-counter sale of 14 steroid creams to prevent indiscriminate sale of ointments containing steroids and antibiotics without prescription. These 14 preparations were included under Schedule H of the Drugs and Cosmetics Rules, 1945 to impose the ban.

Key Facts

The decision was taken following consultation with Drugs Technical Advisory Board (DTAB), which had recommended ban on sale of such creams without prescription. It also had submitted their recommendations to Central Drugs Standards Control Organisation (CDSCO).

The move comes after dermatologists complained that pharmaceutical companies were selling steroid-based creams to patients, who use them without medical guidance. Some banned ointments are beclomethasone, desonide, alclometasone and fluocinonide among others.

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.

Schedule H Drugs

Schedule H is a class of prescription drugs listed under Drugs and Cosmetics Rules, 1945 which governs manufacture and sale of all drugs in India. These are drugs cannot be purchased over counter without prescription of qualified doctor.  It is revised time to time on advice of DTAB,

Month: Categories: India Current Affairs 2018

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