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DCGI to renew focus on NE states to assess drug quality and GMP standards
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Shardul Nautiyal, Mumbai
January 29 , 2015
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The sampling exercise started by Drug Controller General of India (DCGI)
in States like Jammu and Kashmir, Himachal Pradesh, Maharashtra, Tamil
Nadu, Maharashtra, Rajasthan and Chhatisgarh last year will now also be
taken up in North Eastern (NE) states to assess the quality of drugs in
the coming months.
Against the backdrop of the fact that several
drug manufacturers have continuously received warnings and import ban
orders from the US Food and Drug Administration (USFDA), DCGI is
planning to renew its focus on states like UP, MP, Bihar, Rajasthan and
other NE states for scrutiny on drug quality and GMP standards.
DCGI
believes that current regulatory requirement has to be viewed from an
Indian perspective, rather than a direct comparison with developed
markets. A senior CDSCO official informed that around 77 samples were
collected for analysis at Chhatisgarh and around 60 drug samples at
Rajasthan during the random sampling as a part of the exercise meant to
keep a stringent check on the quality of medicines. “It will be an
ongoing exercise in coordination with state drug regulators to enhance
enforcement for arriving at drug quality. The exercise would sensitise
state drug regulators in enforcing GMP standards more stringently,” DCGI
Dr G N Singh asserts.
The exercise involves the process of
drawing samples of medicines from public healthcare institutions and
retail pharmacies. The samples are then sent for testing to government
authorised labs across the country to check their quality and efficacy.
Last year, India-made medicines were losing sheen the world
over, due to constant alerts from international drug regulators. Against
this backdrop, DCGI wants to ensure quality in the domestic market.
Incidents such as the Chhattisgarh sterilisation tragedy, followed by
the Punjab eye cataract mishap, have added to the worsening view of
Indian healthcare.
While the FDA is tightening its stand on
generic drug makers, Indian stakeholders feel adequate resources are
lacking to improve GMP in India. The Indian regulator has 1,200-1,500
officers; the FDA has close to 13,000. Experts believe 20,000 officers
would be required to adequately inspect all drug facilities.
A
total of additional 1195 posts were sanctioned for the upgradation of
manpower and labs under the 12th five year plan. Central Government has
allocated Rs. 900 crore for enhancing manpower and capacities of
minilabs at port offices and mobile labs at CDSCO level.
India
has a little over 10,000 manufacturing drug units. Informs a CDSCO
official, "We expect to double the manpower and enhance the lab
infrastructure both at the centre and states by the end of 2017. CDSCO
has also conducted 17 training programmes to train drug inspectors on
carrying out GMP inspections in the year 2013-14 to ensure quality of
drugs supplied to over 200 countries from India."
"The practice
of deputing drug inspectors as observers through joint inspections has
been able to help draw suggestions and feedback from our global
regulatory counterparts on continuing GMPs. It will help manufacturers
in adopting global practices followed in other countries where our
medicines are consumed," he adds.
He further said that US FDA's
workshops on GMP and CGMP compliance for the first time in four cities
of India in partnership with Central Drugs Standard Control Organisation
(CDSCO) last year has been well received as over 60 pharma companies
participated in the workshop.
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