Following SC orders, CDSCO asks Pharma manfacturers submit data on 66 fixed-dose combinations

New Delhi: In continuation of the series of directives that the FDC Division, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services,GoI, has issued yet another directive asking manufacturers/stakeholders to submit data on 66 fixed-dose combination drugs 

The CDSCO in its order has directed that manufacturers/stakeholders may submit the information/data w.r.t 49 FDCs as well as 17 FDCs. The last date of submitting the data is 30.05.2020. The move comes in Consideration of the directions of Hon'ble Supreme Court of India in the case of 294 FDCs.

The notice issued by Dr VG Somani, Drug Controller General of India recently, stated 

In view of representations received in the matter for extension of time for submission, it has been considered the manufacturers/stakeholders may submit the information/data w.r.t 49 FDCs as well as 17 FDCs by 30.05.2020. Further, it may be informed that in case of failure to submit the data/information by 30.05.2020, the decision will be made on basis of information available before this office in light of the judgement of the Hon'ble Supreme Court.

A copy of the DCGI letter has also been sent to all state drugs controllers, CDSCO Zonal and Sub-Zonal offices and Indian Drug or Pharmaceuticals Association Forum.

Medical Dialogues team had earlier reported that the Central Drugs Standard Control Organization (CDSCO) has pulled up the Fixed-Dose Combination (FDCs) manufacturers and directed them to submit an application for category 'd' Fixed-Dose Combinations (FDCs) as per Kokate Committee Report by May 30, 2020.

The Kokate Committee, headed by Prof. C. K. Kokate, Former Vice-Chancellor, KLE University, Karnataka, examined the Safety and Efficacy of unapproved FDCs which were licensed by State Licensing Authorities without due approval of DCGI.

The Committee had examined 418 applications of FDCs and found 324 FDCs as irrational while only 28 FDCs as rational. The panel had further stated that they require more data for 2 FDCs and 4 FDCs require further deliberation. It was also observed that out of the remaining 60 FDCs, 48 FDCs have already been prohibited, 11 have been declared rational and one FDC is sub judice.

The last date for filing such application was decided as November 22, 2019. However, with the expiry of the last date, CDSCO has provided another chance to the FDC manufacturers by giving them more time for submission of the application. In this regard, the apex drug regulator has extended the last date till May 30, 2020.

Read Also: CDSCO pulls manufacturers for failing to submit application for category d FDCs; Details

To check out the notice click on the following

https://business.medicaldialogues.in/pdf_upload/pdf_upload-124643.pdf