With a view to address the problems rising out lack of policy guidelines and procedure to approve the fixed dose combinations (FDC's) across the country, expert committee which was set up by the Central Drugs Standard Control Organisation (CDSCO) recently, is soon expected to meet in the coming months. The five member expert committee will basically deal with formulating the much needed policy guidelines and procedures for the safety of the patients through out the country.
The committee headed by professor C K Kokate, vice chancellor, KLE University, Belgaum, set up by the government to formulate policy guidelines and procedure for approval of FDC's is soon expected to initiate first meeting of this committee for framing of the policy. Dr HG Koshia, commissioner, Gujarat FDCA who is the only drug regulator in the committee informed that the details of the meeting have yet to finalised, however he prompted that the first meeting will be held in a month or two based on discretion of the chairman of the committee.
He informed, “Our main focus will be on drafting strong policy in the absence of one, for the approval of FDC's in the country, after taking into consideration the genuine interest of all the manufacturers concerned in this matter. Most importantly, our prime agenda would be, to take into consideration all the requirements and safety parameters that are essential before granting approval for the use of FDC's to avoid the exposure of patients to unnecessary risk of adverse drug reactions. We look forward to have a close collaboration with all the stakeholders in this matter so that we can get their detailed suggestion and standpoint on this issue.”
He further pointed out that as an expert committee their main aim will to build a strong policy framework that will effectively aid them in addressing the issues rising out of the use of irrational FDCS in the country. “Under the present condition it is essential to frame policy guidelines which are suited to meet the regulatory requirements of the country so as to bring a complete stop to the use of irrational FDCS throughout the country.”
FDCs are combinations of two or more active drugs in a single dosage, however the fixed ratio combination products are acceptable only when the dosage of each ingredient meets the requirement of a defined population group and when the combination has a proven advantage over single compounds administered separately in therapeutic effect, safety or compliance.
Dr Koshia who is one among the five member team added that in India over the past few years there has been a disturbing trend of large scale availability and use of the FDCs. Following which, the grant of manufacturing licenses for sale of FDC's, which fall under the definition of a new drug without the due approval of the DCGI have been a constant point of debate.