|
The Indian Drug Manufacturers' Association (IDMA) has urged the DCGI not to make phase IV trial mandatory for justification of the irrational fixed dose combinations (FDCs) as the SMEs cannot afford the expenditure of phase IV trial which is around Rs. 60 lakhs per product. Recently, the DCGI had issued show cause notices to companies making FDCs considered irrational by Prof Kokate Committee.
Some time back, the Professor Kokate Committee was asked by the government to review the FDCs in the country. The committee classified the FDC products as rational and irrational. Based on the report, the DCGI office has issued letters of NOCs for certain safe FDCs, and show cause notices on certain FDCs considered irrational.
The manufacturers have been asked to give their response within 90 days and the manufacturers of certain FDCs were asked to justify the combination through phase IV trial. The association has requested to the DCGI that the manufacturers who consider that they have genuine justification for their combination need to be given a personal hearing before any decision is made to stop manufacturing of such FDCs.
S V Veerramani, president of IDMA says, “We are requesting DCG(I) not to conduct phase IV trial as it is costly instead of that we can submit product safety data. We are discussing the matter of SLA approved FDCs with CDSCO for last two years. The manufacturers were asked to submit their justification within 30 days but we requested the DCG(I) to extend it to 90 days. The opportunities should be given to the individual manufacturers.”
The State Licensing Authorities (SLAs) had given permission to manufacture and market FDC products whose ingredients were already in use and being prescribed regularly by the medical professionals- may be even for 20-30 years, or more. The DCG(I), as directed by the health ministry under 33-P, called for submitting efficacy and safety data for all combination SLA-approved products prior to October 1, 2012.
The pharma companies had applied for their already marketed FDCs with relevant data in Form 44. the industry also requested for classifying the products as rational, may be doubtfully safe and efficacious, and grossly irrational.
The association requested that the products which are not considered as irrational to be cleared by DCG(I) on the basis of its usage by medical profession over several year without any adverse reaction. FDCs of vitamins, minerals, other nutrients; probiotics/prebiotics/synbiotics, antacids/enzyme formulations, cough and cold permutation combination products, topical and such simple FDCs should be cleared as rational in view of these unlikely to have any concern with respect to safety concerns and being used on day to day basis as household products.
FDCs contribute 40 per cent of the Indian pharmaceutical market and in case these FDCs are discontinued abruptly, the Indian patients will be deprived of these affordable medicines and the manufacturers, retailers etc ie the distribution chain, will be left with depleted stock resulting in substantial loss, especially to the small scale sector. India is the world leader in FDCs and today, even regulated markets are seeing introduction of more combination product progressively. Hence the bias against the FDCs, if any, would be retrograde step and negate the great achievements made by the Indian pharma manufacturers, opined IDMA.
|