Kokate Committee releases list of 471 rational FDCs 

The Prof Kokate Committee has declared 471 fixed-dose combinations (FDC) related to vitamin, minerals and micronutrients as rational. Following the committee’s assessment, the Drugs Controller General of India (DCGI) has also approved them and allowed the state licensing authorities (SLAs) to grant product licenses without the DCGI’s non-objection certificate (NOC).

However, with requisite fee requirements for each FDCs, which is close to Rs two lakhs, industry stakeholders seek support from the regulatory authority.

Since 2018, the Prof Kokate Committee has announced the list of rational drugs twice; first to 1681 FDCs, then 450 FDCs and now to 471 FDCs related to vitamins, minerals and micronutrients. The latest list of rational drug is also accepted by the Ministry of Health and Family Welfare (MoHFW).

For the grant of product licenses for these 471 approved FDCs, manufacturers, as well as SLAs, need to follow defined procedures such as:

1) The applicant needs to submit the requisite fees preferably through Bharatkosh for each FDC to CDSCO as specified under the Drugs and Cosmetic Act, 1940 and existing Rules thereunder

2) The applicant needs to submit an application to the concerned SLA as per the provisions of Drugs and Cosmetic Rule 1945 for grant of product manufacturing licenses giving the details of FDC, serial number of FDC in the list, stability study data (six months accelerated), test specifications of the FDC alongwith the method of analysis as well as label and other documents as required for grant of product license under Drugs and Cosmetic Rules

3) State Licensing Authority shall grant the product license of such FDCs without seeming NOC from DCG(I), if other conditions of licenses under the Drugs and Cosmetic Rules, which need to be verified by SLA, are found to have been fulfilled. The SLA shall verify the quality of such FDCs of each applicant/ manufacturer before grant of license

4) Every manufacturer permitted to manufacture these FDCs needs to submit the periodic safety update reports (PSUR) as per new Drugs and Clinical Trial Rules 2019 to the central licensing authority as defined in Rule ‘3’ i.e., DCGI. Failure to suit the PSUR will be considered as a contravention of these rules

Besides this, in its letter to all State and Union Drug controllers, the DCGI has also requested them to ensure that no product license is granted in respect of the FDCs which are not approved and mentioned in the latest list of 471 FDCs.

Applauding the move, Dr Rajendra Sanghavi, Chairman – Nutraceutical Committee, IDMA commented, “We appreciate the evaluation process carried by the Prof Kokate Committee in declaring 471 FDCs related to vitamin, minerals and their permutations and combinations as rational. We are also thankful that the DCGI is facilitating the approval of these nutritional FDCs with defined pathways for their licensing.”

He stressed, “For a nutritional combination product there is no practical rationalisation that can be done akin to other drug FDCs. Nutritional FDCs can be considered safe and valuable for use since these are all already being consumed and being advocated for their varied related benefits over the course of a reasonable timespan. No purpose would have been served by discontinuing these useful nutritional FDCs except if they had contained any ingredient that is banned, or had inappropriately incorporated amounts exceeding the tolerable upper limit (TUL).”

Commenting on the development, Dr Gopakumar Nair, Patent Attorney and CEO Gopakumar Nair Associates said, “In combination therapy, India has been an innovator globally. Indian pharma companies have introduced rational combination therapy for the benefit of the patients. However, down the line, a few manufacturers circumvent under the drug price control order by introducing an irrational combination, with no benefits were of for the patients. This led to the defamation of the some combination therapy initiative, which eventually led to the Kokate Committee’s recommendation. Now, after declaring some combinations irrational and eliminating them, combination therapy and its benefits are being recognised. Such a listing of the new combination by the Indian regulatory body is a welcome step.”

While commenting on the increase in the fee for each product, he added, “In my personal opinion, the Indian regulators are really bringing up the Indian regulatory standard at par with the global standards, therefore, there should be a commensurate increase in application fees. It will ensure that genuine manufacturers enter into the FDC drug market.”

Ashish Prasad, Partner- Economic Laws Practice, expressed, “I am hoping that the government has thought through its decision of increasing fee for grant of approvals. While on one hand, it may appear excessive but on the other hand, it may be necessary for ensuring proper infrastructure to enhance testing capabilities. On a lighter side, the market size will justify these costs for the industry and keeps the non-serious players at bay. The recent list of drugs considered ‘rational’ is a vindication of the challenge made to the earlier decision which banned FDCs and also shows the extensive examination undertaken for arriving at an objective decision. This is truly applaudable.”

However, Dr Sanghvi opined differently and said, “Considering the fact that these are already marketed drugs, the application fee for such FDCs is Rs 15,000/- similar to that mentioned in the circular dated June 5, 2017, stating the procedure for licensing of subsequent applications for SLA-approved FDCs by Kokate Committee.”

Another industry observer has raised concerns pertaining to classification and points out that some of the combinations which are well defined and called as rational drugs (new 471 FDCs) have already been approved by the FSSAI.

The CDSCO had earlier issued letters on December 12, 2018, and January 1, 2020, to all the State Licensing Authorities (SLAs) requesting them to ask concerned manufacturers to follow procedures for obtaining manufacturing licenses directly from SLAs.

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