The Drug Controller General of India (DCGI) has directed the state drug controllers to follow a 2-prong strategy framed by him in weeding out irrational drugs from the market. The DCGI has also directed the state drug controllers not to give manufacturing licenses henceforth to fixed dose combination drugs without the approval of the DCGI office in Delhi.
The DCGI rolled out his strategy at the two-day meeting of state drug controllers at NIPER in Chandigarh on October 26-27. He asked the state drug controllers to speed up the process of weeding out irrational combination drugs from the market. In the meeting, the state regulatory authorities of various states were given a presentation by the DCGI. The DCGI is learnt to have involved the assistance of around 100 pharmacologists in framing his strategy.
With the help of the pharmacologists, the DCGI has divided the 294 FDCs in question broadly into three categories. The first category is consisting of 120 combinations which are classified as banned, absurd and rejected. They are 16 absurd, 15 banned and 89 rejected. In the second category, there are 150 which need further examination. In the remaining 24 cases, five combinations are already approved whereas the rest require submission of clinical trial data, BE study and expert opinion.
In the first phase, the DCGI has asked the state drug controllers to withdraw all combination drugs in the absurd, banned and rejected categories from the retail, wholesale and C&F agents immediately. There has been no disagreement on this from the industry representatives.
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In the second phase, the DCGI has directed the state drug controllers to withdraw the drugs in the 150 under observation category from the wholesalers and C& F agents.
Industry has taken strong objection to the DCGI direction in the case of 150 FDCs which are under examination. The industry is of the view that since these drugs are under examination only and no adverse reactions are established at present, these drugs should be allowed to be manufactured and distributed.
By his own admission, the DCGI is on record saying that the DCGI office will come out with a result on the 150 combinations under examination in around 40 days. The industry has asked the DCGI to allow the drug units to manufacture these products till the DCGI comes out with his decision on these items. Stopping production immediately will result in huge financial loss to the companies, industry sources said. The industry associations will be meeting shortly to decide further course of action as the stand on DCGI on withdrawal is very clear.