DTAB constitutes sub-committee to evaluate 324 irrational FDCs in three months time
The Drugs
Technical Advisory Board (DTAB) of the Union health ministry has constituted a
sub-committee to evaluate 324 irrational fixed dose combinations (FDCs) based
on Prof C K Kokate Committee final report and has directed the sub-committee to
come out with final report in three months time. The matter was deliberated at
the 82nd meeting of the DTAB held on April 2, 2019.
The sub-committee has been formed under the chairpersonship
of Dr Nilima Kshirsagar, Chair in Clinical Pharmacology, Indian Council of
Medical Research (ICMR), Mumbai to evaluate Kokate Committee report on 324 FDCs
considered as irrational.
After examining 418 applications of FDCs, the Kokate
Committee found 324 FDCs as irrational, 28 FDCs as rational, 2 FDCs require
further generation of data and 4 FDCs require further deliberation after
evaluating all the data submitted.
It was also observed that out of the remaining 60 FDCs, 48
FDCs have been prohibited, 11 FDCs have been already declared as rational and
one fall under sub-judice category by the Kokate Committee which were placed in
the list of these 418 applications of FDCs inadvertently. Therefore, the Kokate
Committee did not make any recommendations on these 60 applications of FDCs.
The report of the Kokate Committee was placed before the DTAB
for deliberation. The Kokate Committee in its report opined that these FDCs
wherever recommended as “irrational (category ‘a’)” should not be allowed for
their continued manufacturing and marketing in the country. The FDCs which have
been declared as irrational needs to be prohibited under Drugs and Cosmetics
Act (D&C Act), 1940 as other safer alternatives to those combinations are
available.
Other members of the sub-committee are Prof Dr T V Narayana,
president, IPA, Bengaluru, Dr Sandeep Bavdekar, former Professor and Head of
Paediatrics Department, TN Medical College and BYL Nair Charitable Hospital,
Mumbai, Dr. Nirmala Rege, former Professor and Head, Pharmacology Department,
Seth G S Medical College and KEM Hospital, Mumbai, Dr RN Tandon, Immediate Past
Honorary Secretary General, Indian Medical Association (IMA), New Delhi, Dr B
Gupta, Professor and Head, Department of Medicine, NDMC Medical College and
Hindu Rao Hospital, New Delhi, H Mahapatra, Former Drugs Controller, Odisha and
Sanjeev Kumar, deputy drug controller (India), (DDC)(I), Central Drugs Standard
Control Organisation (CDSCO) (HQ), New Delhi.
The Chairperson of the sub-committee may co-opt other experts
from relevant field as deemed necessary for the purpose. The sub-committee
shall furnish its report within three months, DTAB report stated.
Union health ministry had on September 16, 2014 constituted a
committee under the chairmanship of Prof C K Kokate, Former Vice-Chancellor,
KLE University, Belgaum, Karnataka for examining the safety and efficacy of
unapproved FDCs which were licensed by state licensing authorities (SLAs)
without due approval of Drug Controller General of India (DCGI).
After holding a series of meetings the Kokate Committee had
submitted its second assessment report to the Union health ministry on May 27,
2016 categorizing FDCs into “irrational (category ‘a’)”, “requiring further
deliberation (category ‘b’)”, “rational (category ‘c’)” and “FDCs requiring
generation of data (category ‘d’)”.
Accordingly show cause notices were issued by CDSCO to the
applicants in respect of FDCs which were considered as irrational (category
‘a’) to the concerned manufacturers. This was the fourth and final assessment
of such FDCs considered by the Kokate Committee.
Replies, so received against notices with respect to FDCs
considered as irrational under category ‘a’, were placed before the Kokate
Committee for examination. The Kokate Committee discussed total 418 FDCs in
detail in consultation with subject experts of relevant therapeutic area.
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