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DTAB to hold 78th meet on Feb 12 to deliberate cases of FDCs ban & key amendments in D&C Act

Laxmi Yadav, Mumbai
Saturday, February 10, 2018, 08:00 Hrs  [IST]

The 78th meeting of the Drugs Technical Advisory Board (DTAB), the highest decision making body under the Union health ministry on technical matters, will be held in New Delhi on February 12, 2018 to deliberate on a 13-point agenda including proposal for examination of cases of 349 FDCs that have been banned pursuant to the Kokate Committee report.

The Supreme Court had asked the DTAB to decide on the fate of 349 FDCs banned by the government between March 2016 and June 2017 under Section 26A of the Drugs and Cosmetics Act and submit a report with its recommendations to the government within six months.

DTAB will also deliberate a proposal for denotification of GSR 743(E) dated 10.08.1989 issued under section 26A for prohibition of all fixed dose combination injectable preparations containing synthetic oestrogen and progesterone as well as proposal to clarify whether the centchroman (30mg) tablets to be exempted from the provisions of chapter IV of the D&C Act and Rules under Schedule K or to sell the remaining strengths under Schedule H of D& C Rules.

Besides this, DTAB will also look into the proposal to amend the Medical Devices Rules, 2017 for smooth and uniform implementation following representation from the industry/ stakeholders/associations in this regard.

The said rules are effective from January 1, 2018 to regulate the clinical investigation, manufacture, import, sale and distribution of the medical devices in the country.

The other issues to be taken up by DTAB at the meet include proposal for amendment of Para 10.9 of Schedule ‘M’ of Drugs and Cosmetics Rules, 1945 for waiver of requirement for vaccines manufactured using less than 60% residual shelf-life period in the country, proposal for review of prophylactic doses mentioned under Schedule ‘V’ of Drugs And Cosmetics Rules,1945 vis a vis the doses prescribed under FSS Act, proposal for amendment of Rule 127(2) of the Drugs And Cosmetics Rules, 1945, so as to remove the ambiguity and scope of different interpretations in case of use of colours in empty gelatine capsules (hard and soft) and proposal to amend Schedule D of the Drugs and Cosmetics Rules, 1945 to provide exemption for radiopharmaceuticals from the provisions of the Chapter III of the Drugs and Cosmetics Act, 1940.

The meet will also discuss proposal for amendment of rule 96 under Drugs & Cosmetics rules, 1945 for disclosure of prices at first point of sale/price to trade (PTT)/ Ex-factory price or import price and proposal for amending Drugs & Cosmetics Rules to have Single Licensing Authority instead of multiple licensing authorities having experience in manufacture or testing of drugs or enforcement of provisions of the act for a minimum period of 10 years. It will further discuss reconstitution of sub-committee of Drugs Technical Advisory Board on Homeopathy.

The proposal for inclusion of ultrasound equipments and similar imaging equipments under the purview of Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 as Medical Devices, inclusion of separate form for issuing test reports to other than manufacturers like the procurement agencies and others. and proposal to notify (I) Kamarajar port ltd., Chennai, Tamil Nadu and (II) Mundra Port, Kutch, Gujarat; for import /export of drugs/pharmaceuticals will also be discussed during the meet.

DTAB will also consider the proposal for exemption under para 15 of DMR(OA), 1954 to communicate "fever" for creating public awareness on management of fever associated with common self- limiting conditions such as fever associated with common cold and flu, dengue, chikungunya, fever associated with vaccination etc and proposal for inclusion of separate form for issuing test reports to other than manufacturers like the procurement agencies and others.


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