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.