**Summary:**
This circular, reference number F. No. ImpMisc202020, issued by the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), Import and Registration Division on December 9, 2020, clarifies the regulatory status of reference standards. Expanding on previous guidance (letter X190141004D dated 17.11.2004), the CDSCO clarifies that reference standards, working impurity standards, general chemicals, and reagents imported for analytical calibrating or referencing purposes, and *not* intended for use in the diagnosis, treatment, mitigation, or prevention of diseases in humans or animals, may not be subject to drug regulations. The circular emphasizes that such standards should be clearly labeled as intended for analytical/referencing use only. This clarification is communicated to all Zonal/Sub-zonal/Port Offices of CDSCO and stakeholders via the CDSCO website. The issuing authority is Dr. V. G. Somani, Drugs Controller General India.
Key Entities Referenced
Directorate General of Health Services: An organization of the Government of India.
Central Drugs Standard Control Organization (CDSCO): A national regulatory body for pharmaceuticals and medical devices under the Government of India.
New Delhi, Delhi: Location of the Central Drugs Standard Control Organization (CDSCO) office.
Central Drugs Testing Laboratory, Mumbai, Maharashtra: A drug testing laboratory in Mumbai consulted regarding reference standards.
Reference Standards: Substances of known purity used for analytical calibrating or referencing, not as drugs.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO).
Dr. V. G. Somani: The Drugs Controller General of India at the time of the circular.
All Zonal/Sub-zonal/Port Offices of CDSCO: The various regional offices of the Central Drugs Standard Control Organization (CDSCO).
F. No. Imp/Misc/20/2020-DC
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(Import and Registration Division)
FDA Bhawan,
Kotla Road New Delhi 110002
pate yg DEC 2020
CIRCULAR
Subject-Clarification regarding Reference Standards - Reg.
In continuation to letter X-19014/10/04-D dated 17.11.2004 issued by this office, in
one of the case for clarification regarding reference standards, wherein, after
consultation with the Director, Central Drugs Testing Laboratory, Mumbai, it was
communicated in the matter that Reference Standards are substances of known purity
which are intended to be used exclusively for a specified analytical calibrating or
referencing and not to be used as drugs, which may be clearly stated on label and/or
accompanying certificate or literature.
Accordingly, for import of reference / working / impurity standards / general chemicals/
reagents, which are not intended to be used for or in the diagnosis, treatment,
mitigation or prevention of any disease or disorder in human beings or animals, may
not attract the provisions applicable for drugs.
oa
(Dr. V. G. Somani)
Drugs Controller General (India)
To
All Zonal/Subzonal/Port Offices of CDSCO
Copy for information to:
All stakeholders through CDSCO website