Even as the issue of fixed dose combinations (FDC) is stuck in legal wrangle, the Central Drugs Standard Control Organisation (CDSCO) has constituted an expert panel to frame guidelines to help the State licensing authorities to handle the issue in a better and more transparent manner.
The panel was constituted following the general complaints by the state drug authorities that the absence of clear-cut guidelines in respect of FDCs often created problems and many were granting permissions only on the basis of information available with them.
The committee consists of Drugs Controllers or their representatives from the States of Gujarat, Odisha, Himachal Pradesh, Tamil Nadu, Pondicherry, Maharashtra and Rajasthan with A K Pradhan, Deputy Drugs Controller (India), as the convenor.
The committee will prepare guidelines under which the States should grant licences for fixed dose combinations. The committee will also prepare the list of FDCs which have been approved by the office of DCGI as a new drug. It will recommend a cut-off date in respect of conventional FDCs which were there before the introduction of the definition of the term ‘new drug’, sources revealed.
Apart from observations by the state authorities, the recent report of the Parliamentary Standing Committee on Health also prompted the authorities to think seriously over the issue of FDCs. The panel, which came down heavily on the functioning of the CDSCO, had also made critical comments on the FDCs, while calling for “a clear, transparent policy for approving FDCs based on scientific principles.”
The office of DCG(I) had earlier written to the State Drug Control Authorities in respect of 294 FDCs which attracted the said definition and were required to be withdrawn from the market. It was decided that the State Licensing Authorities would direct the manufacturers to stop manufacturing these FDCs and to withdraw the products from the market. The manufacturer Associations however, filed the petition in the High Court of Madras and the court had granted stay order in the case. The matter is sub judice.