**Policy Summary: Universal Adoption of Good Manufacturing Practices (GMP) by Pharmaceutical Sector**
This notice, issued by the Drugs Controller General of India, Central Drugs Standard Control Organization (CDSCO) on 09 May, seeks to ensure the universal adoption of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) by the pharmaceutical sector, as specified under Schedule M and Schedule L1 of the Drugs and Cosmetics Act and Rules. The policy follows deliberations at the highest level regarding self-certification by pharmaceutical units, third-party certification, and detailed audits.
CDSCO had previously developed a detailed checklist for manufacturing facilities to assess their compliance with GMP/GLP requirements, including a tool kit for verification and benchmarks for rating units based on potential risk to medicine users. A prior notice (No. 7 52016misc041 dated 23.07.2015) requested drug manufacturers and pharmaceutical associations to conduct self-assessments and share reports with State Licensing Authorities and CDSCO. However, these reports have not been received.
Therefore, this notice directs all State Drugs Controllers to instruct drug manufacturers under their jurisdiction to submit a self-assessment report, along with self-certification confirming compliance with GMP/GLP requirements as per the Drugs and Cosmetics Rules, to both the State Drugs Controller's office and CDSCO by 30.08.2017.
The notice is addressed to all State Drugs Controllers. Information copies are provided to PPS to JS R, MoHFW. Inquiries may be directed to Dr. G.N. Singh, Drugs Controller General India, FDA Bhavan, Kotla Road, New Delhi-110002.
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.
Good Manufacturing Practices: A set of guidelines and regulations that ensure pharmaceutical products are consistently produced and controlled according to quality standards.
Good Laboratory Practices: 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 that specifies the requirements for Good Manufacturing Practices (GMP) in India.
Schedule L1: Part of the Drugs and Cosmetics Act and Rules, likely related to specific requirements for manufacturing, possibly related to specific drug types or facilities.
Drugs and Cosmetics Act: The primary legislation in India that regulates the import, manufacture, distribution, and sale of drugs and cosmetics.
State Drugs Controllers: The heads of the drug regulatory agencies in each state of India, responsible for enforcing drug regulations 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: 0 9 M q ¢ \\]
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, State Drugs Controllers are requested to direct all the drug manufacturers
under their jurisdiction 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 your good office and CDSCO by 30.08.2017.
(Dr. G.N. Singh)
Drugs Controller General (India)
To:
All State Drugs Controllers
Copy for Information to:
PPS to JS (R), MoHFW