Even though the Parliamentary panel blasted the Health Ministry for its half-hearted measures on most of its recommendations on the Central Drugs Standard Control Organisation (CDSCO) functioning, the panel has expressed satisfaction on the moves taken on the fixed dose combinations (FDCs) issue. However, the Standing Committee asked the Government to reduce the time given to prove efficacy and safety of the FDCs from 18 months to nine months as it involves the safety of the people.

“The Committee derives satisfaction from the fact that at last in pursuance of its recommendation the issue of manufacturing licences to unauthorized FDCs has been centre staged after more than eleven years, and discussed in the Drugs Consultative Committee meeting held on July 20, 2012. It further notes with satisfaction that the Ministry has issued statutory direction under Section 33P to State governments on October 1, 2012 to refrain from granting drug licences including FDCs without the approval of DCG(I). The Ministry has also indicated its intention to take action against the 294 FDCs which are a subject of litigation in Madras High Court based on the outcome of the case,” according to the latest report by the panel.

“Further more, in regard to FDCs licenced by the State Authorities before October 1, 2012, the State Authorities have been asked to direct the manufacturer concerned to prove safety and efficacy of such FDCs before the CDSCO within a period of 18 months or invite prohibition for manufacture and marketing. The Committee feels that 18 months is too long a period for the purpose of proving efficacy and safety of these products. As in the eventuality of these being harmful or less advantageous to health and well being of public can cause incalculable damage in this long interregnum. The Committee therefore strongly recommends that this period should be curtailed to nine months i.e. up to June 30, 2013 without fail,” it said.

According to the original recommendation by the panel in May last year, the committee felt that there was some ambiguity on powers of the State Drug Authorities in this respect. It asked the government to take steps to withdraw the unauthorized FDCs from the market.

“In 2007, direction was issued to the State Drug Controllers to withdraw the 294 FDCs which were licenced without approval of DCG(I). However, the manufacturers' association got stay order from the Madras High Court. The matter is still sub-judice. The Ministry has, however, again issued statutory direction under Section 33P to the State governments on 1. 10. 2012 to refrain from granting new drugs licencing including FDCs without approval of DCG(I). Action in respect of the aforesaid 294 FDCs will be taken after the outcome of the court case in Madras High Court,” according to the Ministry submission before the panel.