**Summary:**
This notice, issued by the Drugs Controller General of India (DCGI), a division of the Central Drugs Standard Control Organization (CDSCO) under the Directorate General of Health Services, addresses the universal adoption of Good Manufacturing Practices (GMP) within the pharmaceutical sector. The notice, dated August 4, 2017, references File No. 752016Misc.041 and follows up on a previous notice dated July 23, 2015, which requested drug manufacturers and pharmaceutical associations to conduct self-assessments of their manufacturing units' compliance with GMP and Good Laboratory Practices (GLP) as specified under Schedule M and Schedule L1 of the Drugs and Cosmetics Act and Rules.
The CDSCO had previously developed a detailed checklist and toolkit for verifying GMP/GLP compliance, including benchmarks for rating manufacturing units based on their potential risk to medicine users, intending for manufacturers to perform self-assessments. Despite the prior request, the CDSCO reports a lack of self-inspection reports received from manufacturers.
Therefore, this notice reiterates the request for all drug manufacturers to submit a self-assessment report of their units, along with a self-certification confirming their compliance with GMP/GLP requirements as per the Drugs and Cosmetic Rules, to both the State Licensing Authorities and the CDSCO by August 30, 2017. This directive is addressed to all drug manufacturers and pharmaceutical associations.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the approval of drugs, cosmetics, and medical devices.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
Good Manufacturing Practices GMP: A system for ensuring that products are consistently produced and controlled according to quality standards.
Good Laboratory Practices GLP: A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported.
Schedule M: A part of the Drugs and Cosmetics Act and Rules in India that specifies the requirements for Good Manufacturing Practices.
Schedule L1: A part of the Drugs and Cosmetics Act and Rules in India related to Good Laboratory Practices.
Drugs and Cosmetics Act: Legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
State Licensing Authorities: Regulatory bodies at the state level in India responsible for licensing and regulating drug manufacturers and pharmaceutical companies within their respective states.
File No. 7-5/2016/Misc./041
Directorate General of Health Services
Central Drugs Standard Control Organization
(O/o Drugs Controller General India)
FDA Bhavan, Kotla Road,
New Delhi-110002
Date: 04-0 a-\7
NOTICE
Issues related to universal adoption of Good Manufacturing Practices (GMP) by
pharmaceutical sector and to explore the possibility of self certification by the pharmaceutical units
followed by third party certification followed by detailed audit have been deliberated at the highest
level.
In this regard, it may be mentioned that, CDSCO had earlier prepared a detailed checklist for
all manufacturing facilities to comply with the requirements of Good Manufacturing Practices (GMP)
and Good Laboratory Practices (GLP) as specified under Schedule M and Schedule L-1 of the Drugs
and Cosmetics Act and Rules there under. The checklist includes an elaborate tool kit for verification
of GMP/GLP along with benchmarks based on the concept of rating manufacturing units on the basis
of an estimated risk that they may pose to users of medicines. This checklist was devised with a view
to ensure that each manufacturing unit carries out self assessment to GMP/GLP compliance.
All drug manufacturers and pharmaceutical associations were requested vide notice no. 7-
5/2016/misc/041 dated 23.07.2015 to make self assessment of their manufacturing units as part of
their self audit and mandatorily share their reports with State Licensing Authorities and CDSCO.
However, CDSCO is yet to receive self inspection reports from the manufacturers.
In view of above, all drug manufacturers are requested to submit the report of self
assessment of their units along with self certification stating that they are complying with GMP/GLP
requirement as per Drugs and Cosmetic Rules, to the State Licensing Authorities and CDSCO by
30.08.2017.
(Dr.G. N. Singh)
Drugs Controller General (India)
To:
1. All Drugs Manufacturers
2. All Pharmaceutical Associations