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Expert panel headed by Prof Kokate set up to review safety of FDCs
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Nandita Vijay, Bengaluru
October 30 , 2014
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Union health ministry's has assigned an expert panel led by Prof.
Chandrakant Kokate vice chancellor, KLE University, Jawaharlal Nehru
Medical College, Belgaum, Karnataka to review the safety and efficacy of
the fixed dose combinations (FDCs). The committee comprises of over
four members.
The new team of experts led by Prof Kokate who is
from Karnataka will deliberate the issue. However, Karnataka right from
day one has strictly went by the directions of the Drugs Control General
of India in adhering to the guidelines imposed by the regulatory
authority. This could date back to 2002, Raghurama Bhandary, drugs
controller, government of Karnataka told Pharmabiz.
“We are now
given to understand that FDCs are under scrutiny for its safety and
efficacy. All manufacturers in Karnataka have submitted the safety and
efficacy data of the drugs manufactured in the state to the DCGI. Now
the regulatory authority needs to take a decision on this”, added
Bhandary.
In Karnataka, there are several companies which have
submitted the safety and efficacy reports including Micro Labs, Bal
Pharma among others.
Pharmabiz had earlier reported that the
Union government’s move to ban FDCs had impacted several pharma
companies. Early last month, the government was supposed to hold the
seventh meeting chaired by a panel which covered Dr Dipankar
Bhattacharya of IPGMER & SSKM, Kolkatta; Dr Sudhir Gupta of
Government Medical College, Nagpur; Dr Goswami of Guwahati Medical
College, Guwahati; Dr Sanjeev Sachdeva of GB Pant Hospital, New Delhi;
and Dr K Narayan of Madras Medical College, Chennai.
Now with the
creation of the present committee, the new team has to put up with an
enormous task to scrutinise and standardise scores of FDCs permitted for
manufacture and sale in the country without clearance from the DCGI.
There are thousands of FDCs and many pharma companies who had been
engaged in its production and therefore the expert team needs to
evaluate before it arrives at a decision, noted Bhandary.
FDCs
were viewed as irrational and harmful drug combinations requiring a
systematic process of scrutiny. But it is high time the Union government
takes a call on its speedy approval, said pharma companies.
Prof.
Kokate was also the vice-chancellor of Kakatiya University, Warangal,
and Nagarjuna University, Guntur, both in Andhra Pradesh. He was
President of Pharmacy Council of India for two terms and has also served
on various national level committees of NAAC, UGC, and MHRD,. He was
also the president of the 50th IPC in 1998 at Mumbai. He guided 17
students for Ph.D programme and 40 students for post graduate in
Pharmacy. In addition he has authored six books in
Pharmacognosy/Pharmacy. This makes the Karnataka pharma sector to agree
that he could be the right person to head the committee for FDCs.
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