**Summary:**
This office memorandum, issued by the Drugs Controller General India (DCGI) on March 28, 2014, addresses concerns raised by industry stakeholders, including OPPI, FICCI, CII, and IDMA, regarding the relabeling of imported drugs to meet India-specific labeling requirements under the Drugs and Cosmetics Act and Rules. Following a meeting held on March 26, 2014, directed by the Ministry of Health and Family Welfare, the DCGI has granted a general permission under Rule 104A to allow a transition period for relabeling. Specifically, drugs imported under universal packing requiring relabeling are granted a three-month period, while devices and cosmetics are granted a six-month period, to comply with the necessary labeling changes. This decision aims to prevent disruptions in the supply of drugs to patients while ensuring patient safety and well-being. The memorandum is addressed to all Port/Zonal/Sub-Zonal Offices of the Central Drugs Standard Control Organization (CDSCO). Copies have been sent to PPS to Secretary HFW, PPS to DGHS, PS to ASDG, and PS to Joint Secretary R, Ministry of Health & Family Welfare. The contact person for this memorandum is Dr. G.N. Singh, Drugs Controller General India, Office of Drugs Controller General India, FDA Bhawan, Kotla Road, New Delhi.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
OPPI: Likely refers to the Organisation of Pharmaceutical Producers of India, an association representing research-based pharmaceutical companies.
FICCI: Federation of Indian Chambers of Commerce & Industry, an association of businesses in India.
CII: Confederation of Indian Industry, an association of businesses in India.
IDMA: Indian Drug Manufacturers' Association, an association representing pharmaceutical manufacturers in India.
Ministry of Health and Family Welfare: A government ministry in India responsible for public health.
Drugs Cosmetics Act: The primary legislation in India governing the import, manufacture, distribution, and sale of drugs and cosmetics.
DCGI/MISC/2014 (44)
Central Drugs Standard Control Organization
Office of Drugs Controller General India
FDA Bhawan, Kotla Road, New Delhi
Dated: 28" March, 2014
OFFICE MEMORANDUM
In light of various representations received from OPPI, FICCI, Cll, IDMA and
other stakeholders on relabeling issue of imported drugs, a special meeting with the
Stakeholders was heid on the direction of Ministry of Health and Family Welfare on
26" March, 2014.
As Port Offices have started the meticulous implementation of labeling
requirements, therefore, the importing organizations have expressed their inability to
change as per Drugs & Cosmetics rule to India specific labeling in short span of time
and approached DCGI to allow some time for transition from universal to India
specific labeling so that supplies of drugs to the patients are not hampered.
Accordingly, it has been decided in the interest of patients safety and well
being, that those drugs which are imported under universal packing and needs
relabeling post import, in order to comply with Drugs & Cosmetics rules are given
general permission under rule 104-A for three months in cases of drugs and six
months for devices and cosmetics under Drugs & Cosmetics Act and Rules.
(Dr. G.N. Singh)
Drugs Controller General (India)
To
All Port/Zonal/Sub-Zonal Offices of CDSCO
Copy to:
PPS to Secretary (H&FW)/PPS to DGHS/PS to AS&DG/PS to Joint
Secretary (R), Ministry of Health & Family Welfare