This document, issued by the Drugs Controller General of India (DCG I) on May 16, 2017, addresses concerns regarding the approval process for new drugs, including Fixed Dose Combinations (FDCs). It reiterates that, according to the Drugs and Cosmetics Act and related Rules, specifically Rule 122E and Rule 21b, prior approval from the Licensing Authority (defined under Rule 21b) is mandatory before State Licensing Authorities can grant licenses for the manufacture, sale, or distribution of new drugs. The DCG I notes complaints that some State and Union Territory (UT) licensing authorities are granting licenses for new drugs and FDCs without this prior approval. The communication emphasizes that such a practice is illegal and requests all Drug Controllers of States and UTs to immediately cease this practice if it exists, cancel any licenses issued without prior DCG I approval, and submit a report to Dr. G.N. Singh, Drugs Controller General India, at the Central Drugs Standard Control Organisation in FDA Bhawan, Kotla Road, New Delhi 110002.
Key Entities Referenced
Directorate General of Health Services: An organization under the Government of India related to health services.
Central Drugs Standard Control Organisation: A national regulatory body for pharmaceuticals and medical devices in India.
DCG I: Drugs Controller General of India; the head of the Central Drugs Standard Control Organisation.
Drugs and Cosmetics Acts: The primary legislation in India regulating the import, manufacture, distribution, and sale of drugs and cosmetics.
Rule 122E: A rule under the Drugs and Cosmetics Rules related to the definition of new drug approval.
Rule 21b: A rule under the Drugs and Cosmetics Rules defining the Licensing Authority.
FDCs: Fixed Dose Combinations; pharmaceutical products containing two or more active pharmaceutical ingredients in a single dosage form.
Dr GN. Singh: The Drugs Controller General of India at the time of the notification.
DCGI/MISC/2017 (51)
Directorate General of Health Services
Central Drugs Standard Control Organisation
Office of DCG (I)
FDA Bhawan,
Kotla Road, New Delhi- 110002
16" May, 2017.
Dear Colleagues,
As all of you are aware, in terms of the existing provisions of the Drugs and
Cosmetics Acts and thereunder Rules relating to new drug approval, as defined in
Rule 122(E), prior approval of the Licensing Authority defined under Rule 21(b) is
required before granting licence for manufacture for sale or distribution by the State
Licensing Authority.
2 Instructions have been issued from time to time to ensure that in all cases
regarding approval as new drugs including FDCs, the law/rules should be followed
meticulously. Drug regulators of some of the manufacturing States have complained
that the licensing authorities of certain States and UTs continue to grant licenses for
manufacture of new drugs including FDCs without prior approval of the DCG (I).
64 Since, the practice as indicated above, if true, is illegal and not in conformity
with the law and would have disastrous consequences, may | request you to ensure
that this practice be stopped forthwith, if it has not already been discontinued. |
would also strongly urge you to ensure that any such licences issued may also be
cancelled and a report sent to me at the earliest possible.
Yours faithfully
(Dr G/N. Singh)
Drugs Controller General (India)
ALL DRUG CONTROLLERS OF STATES/UTS