FDC Rationality: Now 6 months accelerated stability study data to be submitted, directs DCGI

New Delhi: Manufacturers of Fixed Dose Combinations drugs ( FDC drugs) which have declared rational and approved by Drugs Controller General India (DCGI) will now have to submit 6 months accelerated stability study data rather than 3 months accelerated data for their formulations. The Union Drug Controller recently wrote a letter to its state counterparts to this effect.

The letter elaborated on the procedure to be followed by subsequent applicants in respect of Fixed Dose Combinations (FDCs) declared as rational by Prof. Kokate Committee and approved by Drugs Controller General(India) DCG(I).

The letter directed all the states and Union Territories drug controllers to ask the concerned manufacturers/stakeholders to follow the procedure as laid down by the Directorate for obtaining the product license w.r.t. FDCs declared as rational by Prof. Kokate Committee and approved by Drugs Controller General(India) DCG(I).

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The letter clearly stated that earlier 3 months accelerated Stability studies data was required to be submitted by the applicants for obtaining the product license from drug controller's office.

"However, the matter was discussed in the 55th DCC meeting held on 31-01-2019 & 01.02.2019 and it was decided that applicant should submit 6 months accelerated stability study data in place of 3 months accelerated data so that there is no disparity," the letter added

Accelerated Stability studies are the studies designed to increase the rate of chemical degradation and physical change of a drug by using exaggerated storage conditions as part of the formal stability testing programme. The main aim of accelerated stability study is to predict the stability profile of a drug product that prediction of shelf life of the product before launching into market.

The notification further clarified that the manufacturers who are not holding product licence prior to 01.10.2012 should generate and submit stability study data after obtaining From-29 from the concerned state licensing authority (SLA).

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