**Policy Summary:**
This circular, issued by the Central Drugs Standard Control Organization (CDSCO) on August 9, 2017, addresses the establishment of facilities for activities such as coating, component assembly, and sterilization of medical devices regulated under the Drugs and Cosmetic Act, 1940, and Rules, 1945. The CDSCO has noted that medical device manufacturers are experiencing difficulties in establishing such facilities.
The circular clarifies that these activities fall under the definition of "manufacture" as per clause (f) of Section 3 of the Drugs and Cosmetic Act, 1940. This definition includes any process or part of a process for making, altering, ornamenting, finishing, packing, labeling, breaking up, or otherwise treating or adapting any drug (including devices) with a view to its sale.
Therefore, firms engaging in these activities (coating, assembling, sterilization, etc.) are required to obtain a manufacturing license under the provisions of the Drugs and Cosmetic Act and its associated rules.
The circular directs all State/Union Territory Drugs Controllers to take appropriate action to grant licenses for these activities within their respective jurisdictions.
The circular was issued by Dr. G.N. Singh, Drugs Controller General of India, and distributed to all Zonal/Sub-Zonal offices of CDSCO, the PS to JSR, and the guard file. The file number for this circular is 29Misc032017DC 08.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Drugs and Cosmetic Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
Drugs and Cosmetic Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940 to regulate the import, manufacture, distribution and sale of drugs and cosmetics.
Medical Device: Devices regulated under the provisions of Drugs and Cosmetic Act,1940 and Rules,1945.
New Delhi: The location of Food Drugs Administration Bhawan, India
States/UTs: All the States and Union Territories of India.
Dr. G.N. Singh: Drugs Controller General of India
Directorate General of Health Services: An attached office of the Department of Health & Family Welfare.
File No. 29/Misc/03/2017-DC (08)
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
Food & Drugs Administration Bhawan,
Kotla Road, New Delhi-110002
Date:
CIRCULAR 69 Au 2017
To
All the States/UTs Drugs Controller,
Subject: Establishment of facilities for the activities of coating, assembling of
components, sterilization etc for devices regulated under the provisions of Drugs and
Cosmetic Act,1940 and Rules,1945 thereunder- reg.
It has been brought to the notice of this office that the manufacturers of the Medical
Device are facing difficulties while establishing facilities for the activities of coating,
assembling of components, sterilization etc for devices.
In this connection, it is clarified that as per clause (f) of Section 3 of Drugs and
Cosmetic Act, 1940, the definition of “manufacture” in relation to the drug(devices) includes
any process or part of process for making, altering, ornamenting, finishing, packing, labeling,
breaking-up or otherwise, treating or adopting any drug with a view to its sale.
The processes like coating, assembling of the components, sterilization of devices
etc attracts definition of the “manufacture” under the said Act. Therefore, for such activity,
the firm is required to obtain manufacturing license under the provisions of Drugs and
Cosmetic Act & Rules made thereunder.
In view of above, you are requested to kindly take appropriate action for grant of
license for such activities under your jurisdiction.
(Dr./G.N. Singh)
Drugs Controller Ggneral (India)
Copy to:
1. All the Zonal/Sub-Zonal offices of CDSCO.
2. PS to JS(R).
3. Guard file.