|
Maha FDA cancels 58 mfg licenses, suspends 145 licenses for non-compliance
|
|
Shardul Nautiyal, Mumbai
August 29 , 2017
|
|
|
Maharashtra FDA has canceled 58 manufacturing licenses and suspended 145
licenses based on 2,540 inspections carried out on 2,493 manufacturing
units across the state since April 2016 till date. The cancellations and
suspensions have been done for contravening the provisions of the
Schedule M and Schedule T of the Drugs and Cosmetics Act, 1940 and Rules
thereunder.
This comes at a time when the manufacturing units
are upgrading to the standards followed in regulated markets for which
the state regulator has directed them to do self assessment of their
compliance levels. A risk based inspection comprising officials from the
Central Drugs Standard Control Organisation (CDSCO) and State FDA will
also follow to assess the preparedness of the units towards good
manufacturing practices (GMPs) and help them shield in the event of a
regulatory scrutiny from other regulated markets.
Ongoing audits
by drug regulators of regulated markets along with their Indian
counterparts has also led companies to adopt and upgrade their units in
line with current good manufacturing practices (cGMP).
This will
be a big boost to several Indian drug makers which had come under the
scanner of the global drug regulatory authorities in the recent years
over a range of issues like data integrity, including production
quality, sanitation standards and alleged data manipulation.
As
per the WHO website, GMPs include factors such as sanitation and
hygiene, qualification and validation, self-inspection, quality audits,
suppliers’ audits, prevention of cross-contamination and bacterial
contamination during production, training employees and personal
hygiene.
Aimed at streamlining uniform inspection procedures
across the country related to GMP, Union health ministry has also
directed manufacturers for self assessment of drug regulators as part of
CDSCO's new draft checklist and evaluation tool released recently.
The
checklist and tool will help CDSCO and state drug regulators understand
and collaborate which pharmaceutical and active pharmaceutical
ingredient (API) manufacturing sites have been inspected and are found
to be compliant. The inspections are planned to be carried out jointly
by the CDSCO officials and drug inspectors of the states concerned.
CDSCO
is also planning to bring about uniformity in inspections of Schedule M
units across the country as a part of its programme to upgrade Schedule
M units to WHO-GMP level. The current upgradation of WHO-GMP norms is
being evolved around the learning from global regulatory counterparts on
cGMP to help manufacturers adopt global GMP practices.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|