The Drugs Controller General of India (DCGI) has issued procedures to be followed by manufacturers for subsequent applications in respect of licenses to manufacture fixed dose combinations (FDCs) declared as rational by Prof. Kokate Committee and approved by the DCGI.

As per the directive issued by the DCGI on the pathway to be followed for clearances of such subsequent applications, the applicants who wish to manufacture such FDCs will apply in Form 44 with a fee of Rs.15,000 to the Central Licensing Authority (CLA) through TR (6) challan clearly specifying whether he is already holding product permission from State Licensing Authority (SLA), indicating date of permission or intends to obtain a fresh (new) permission; the period of 4 years to be reckoned from the date of approval of the Kokate Committee recommendation by the Central Government in respect of particular FDC; and the NOC from the Central Licensing Authority under Rule 21 (b) as per Drugs and Cosmetics Rules shall be issued within 30 working days, failing which it shall be deemed to have been approved. Copy of NOC will be mailed to concerned SLA also.

The DCGI directive further says that the State Licensing Authority shall permit the manufacturing of such FDCs, if other conditions of license under Drugs and Cosmetics Rules, which need to be verified by SLA, are found to have been fulfilled. The SLAs shall verify the quality of such FDCs of each applicant/manufacturer, before grant of license as per Drugs and Cosmetics Rules 1945; and every manufacturer permitted to manufacture these FDCs shall submit the periodic safety update reports (PSURs.as per Schedule Y of the Drugs and Cosmetics Rules to the Licensing Authority under Rule 21(b) i.e. DCG(I). Failure to submit the PSURs shall be considered as contravention of these Rules.

The DCGI has asked all the State Licensing Authorities, manufacturers and concerned stakeholders to follow these procedures for clearances of the cases with regard to subsequent applicants in respect of FDCs declared as rational by Prof Kokate Committee and approved by the DCGI.

The issue dates back to 2013, when the DCGI issued a letter dated 15.01 2013 whereby all the State/UT Drugs Controllers were requested to ask the concerned manufacturers in their State to prove the safety and efficacy of FDCs within 18 months which were permitted by State Licensing Authorities without due approval from the office of DCGI.

After examination of such applications received, in consultation with Prof. Kokate Committee constituted by Ministry of Health and Family Welfare, concerned manufacturers were issued NOC for continued manufacturing and marketing in case of FDCs held as rational.

subsequently, the DCGI office received representations from various stakeholders for issuance of permission to subsequent applicants of such FDCs which have been held to be rational and approved by DCGI, i.e. those manufacturers who have license from SLA, but did not obtain NOC from DCGI or those manufacturers who intend to manufacture these FDCs henceforth.

The matter was then examined by the DCGI in consultation with the Ministry of Health and Family Welfare and accordingly this pathway was finalised.