DCGI approves fixed dose combinations suggested as rational by Prof. Kokate Committee

 

DCGI has asked the state drug controllers to direct the drug makers to obtain the manufacturing license of 471 novel fixed-dose combinations that are related to the vitamins, minerals along with the micronutrients that have been declared by Prof. Kokate committee as rational and have got approval from DCGI. This has brought great cheers to all the manufacturers of the drugs especially those who are involved in the manufacturing of vitamins, minerals as well as micronutrients.

This is in continuance to the DCGI letter to all state DCs in December 2018 and January 2020 where all of the state licensing authorities were directed to ask the respective manufacturers to follow the process for getting the manufacturing licenses from SLA.

After approval from the health ministry, it has been decided to follow a specific procedure for granting of product license by SLA in respect of FDC. Applicants have to deposit the required fees through Bharatkosh for every FDC to CDSCO as stated under the Drugs and Cosmetics ACT 1940 and all other existing rules under it. The applicant has to submit the application to the required SLA for grant of required license by giving all details of FDC, a serial number of FDC present in the list, stability studies data, method of analysis, along with test specification of the FDC and all documents needed for grant of the product license as per D&C rules.

SLA will give the product license requiring the NOC from DCGI if all other license conditions as per D&C rules that have been verified by SLA is fulfilled. The SLA will verify all quality of FDC of every applicant before granting the license. DCGI has also stated that all manufacturers who have got permission to manufacture all these FDCs must submit safety update reports according to New Drugs and Clinical Trial Rules 2019 to the central licensing authority. By failing to submit PSUs will be considered as rule contravention.

However, a concern was raised regarding the license fees of about INR 1 lakh for every FDC for MSME. As Covid 19 has put a great impact on MSME because of inadequate resources as well as burrowing ability. Taking this into consideration MSME must be allowed to give license fees of about INR15000 for an FDC rather than one lakh Indian Rupees.

Thus, in this tough time when the pandemic is making life difficult relaxing some of the rules will help in easing the business.

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