**Summary:**
This policy directive, issued by the Drugs Controller General of India (DCGI) on March 20, 2019, addresses the procedure for subsequent applicants seeking product licenses for Fixed Dose Combinations (FDCs) declared rational by the Prof. Kokate Committee and approved by the DCGI. The directive modifies the previously communicated procedure (letter dated December 12, 2018) regarding stability study data requirements. Specifically, applicants are now required to submit 6 months of accelerated stability study data instead of the initially mandated 3 months. This change was decided during the 55th Drugs Consultative Committee (DCC) meeting held on January 31 - February 1, 2019, to ensure consistency in data requirements. The policy further clarifies that manufacturers not holding a product license prior to October 1, 2012, must generate and submit stability study data after obtaining Form 29 from the relevant State Licensing Authority (SLA). The policy is addressed to all State/Union Territory Drugs Controllers. Contact for further information is Dr. S. Eswara Reddy, Drugs Controller General India. Copies of the directive have been circulated to the PS to JSR, Ministry of Health and Family Welfare; all Zonal/Sub-Zonal offices of CDSCO; the Indian Drug Pharmaceuticals Association Forum; and the CDSCO website.
Key Entities Referenced
State/UT Drugs Controllers: The addressees of the letter, representing the drug regulatory authorities in each State and Union Territory of India.
FDCs: Fixed Dose Combinations, referring to pharmaceutical products containing two or more active ingredients in a fixed ratio.
Prof. Kokate Committee: A committee that assessed the rationality of FDCs (Fixed Dose Combinations) in India.
DCGI: Drugs Controller General of India, the head of the Central Drugs Standard Control Organization (CDSCO).
Directorate: Refers to the issuing directorate within the CDSCO, responsible for drug regulation.
55th DCC meeting: The 55th Drugs Consultative Committee meeting held on 31.01.2019-01.02.2019, where decisions regarding stability study data requirements were made.
Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi: The Union Ministry responsible for health policy in India, located in Nirman Bhawan, New Delhi.
CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
Dated:
To, [2 0 MAR 2019
All State/UT Drugs Controllers
Subject: Procedure to be followed for subsequent applicant in
respect of FDCs declared as rational by Prof. Kokate
Committee and approved by DCG(I) -regarding.
Sir,
This is with reference to this office letter dated 12.12.2018 whereby
you were requested to ask the concerned manufacturers/stakeholders
to follow the procedure as laid down by this Directorate for obtaining
the product license w.r.t. FDCs declared as rational by Prof. Kokate
Committee and approved by DCG(I).
As per the said letter; 3 months accelerated Stability studies data
was required to be submitted by the applicants for obtaining the
product license from your office. However the matter was discussed in
the 55"" DCC meeting held on 31-01-2019 & 01.02.2019 and it was
decided that applicant should submit 6 Months accelerated stability
study data in place of 3 months accelerated data so that there is no
disparity.
It is further clarified that the manufacturer who are not holding
product licence prior to 01.10.2012 should generate and submit
Stability study data after obtaining From-29 from the concerned SLA.
Yours Faithfully,
Oxf
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
Copy to:-
1. PS to JS(R), Ministry of Health and Family Welfare, Nirman
Bhawan, New Delhi.
2. All Zonal/Sub Zonal offices of CDSCO
3. Indian Drug/Pharmaceuticals Association Forum
4. Website of CDSCO