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Laxmi Yadav, Mumbai August 05 , 2020
The Drugs Controller General of India (DCGI) has directed the state drug controllers (DCs) to ask drug makers to get manufacturing licenses of 471 new fixed dose combinations (FDCs) related to vitamins, minerals and micronutrients declared as rational by Prof. Kokate Committee and approved by DCGI. This has brought cheers to drug makers manufacturing vitamins, minerals and micronutrients.

This is in continuation to the DCGI letter to state DCs on December 12, 2018 and January 8, 2020 whereby all the state licensing authorities (SLAs) were requested to ask the concerned manufacturers to follow the procedure for obtaining manufacturing licenses directly from SLAs. The list comprising of 1,681 FDCs and 450 FDCs declared rational by Prof. Kokate committee were already forwarded with the said letter to the SLAs.

In continuation to the said letter, it may be noted that apart from these 1,681 FDCs and 450 FDCs, further there are 471 more FDCs related to vitamins, minerals, micronutrients etc which have been declared as rational by the committee and report of the committee has been accepted by the Union health ministry.

Accordingly with approval of the health ministry, it has been now decided to follow a specific pathway for grant of product licenses by the SLAs for these FDCs. Applicants shall submit the requisite fees preferably through Bharatkosh for each FDC to CDSCO as specified under Drugs and Cosmetic (D&C) Act, 1940 and existing Rules thereunder. The applicant shall submit application to the concerned SLA for grant of product manufacturing license giving the details of FDC, serial number of the FDC in the list, stability studies data (6 months accelerated), test specification of the FDC along with method of analysis as well as label and other documents as required for grant of product license under D&C Rules.

The SLA shall grant the product license of such FDCs without seeking NOC from DCGI, if other conditions of license under the D&C 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 or manufacturer before grant of license.

DCGI further stated that every manufacturer permitted to manufacture these FDCs shall submit the periodic safety update reports (PSURs) as per New Drugs and Clinical Trial Rules - 2019 to the central licensing authority as defined in Rule 3 i.e. DCGI. Failure to submit the PSURs shall be considered as contravention of these Rules.

On September 16, 2014, a committee was set up by the health ministry under the chairmanship of Prof C K Kokate, former vice-chancellor, KLE University, Karnataka to look into safety and efficacy of unapproved FDCs which were licensed by the SLAs without approval of DCGI.
 
The committee, after holding a series of meetings had submitted its second assessment report to the health ministry on May 27, 2016, categorizing FDCs into four categories-- irrational (category 'a'), requiring further deliberation (category 'b'), rational (category 'c'), and FDCs requiring generation of data (category 'd').

Hailing 471 more FDCs declared rational by Prof Kokate panel and approved by DCGI, Amit Chawla, general secretary of Madhya Pradesh Small Scale Drug Manufacturers Association said “It will be beneficial for the drug makers in Madhya Pradesh. A large number of FDCs have been in the market for almost a couple of decades and no serious side effects or adverse reactions have been noted.”

However, he expressed concern over licence fees of Rs one lakh for each FDC for MSMEs. “COVID-19 pandemic has severely impacted MSMEs as they have limited financial resources and borrowing capacity. Considering financial challenges faced by MSMEs due to coronavirus pandemic, MSMEs should be allowed to pay licence fees of Rs.15,000 for a FDC instead of Rs one lakh. In 2019 the manufacturers were required to pay registration fees of Rs.15,000 to CDSCO for a FDC along with application and obtain license from SLAs,” said Chawla.

As per DCGI circular in December last year, MSMEs are required to pay only half of the Rs. 2 lakh fees for a FDC declared rational by Prof Kokate committee and approved by DCGI in accordance with provision of New Drugs and Clinical Trials Rules 2019.

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