Karnataka drugs control department has commenced its audit of GMP or
Schedule M compliance adhered to by the units across the state. A team
of four drug inspectors is short listed for the audit which is an
inspection -cum -survey. The team will visit the 236 plants in Karnataka
and ascertain the level of adherence. The audit is between January to
March, 2011 and these officers will be at various locations for the next
90 days, Dr BR Jagashetty, Karnataka Drugs Controller told Pharmabiz.
The
pharma plants have been extremely diligent in adhering to the Schedule M
norms. In fact, the state is known to be on par with Maharashtra and
Gujarat on compliance with GMP, he added.
Pharmabiz had reported
that Karnataka has around 236 pharma production plants which is a mix
of multinational, large and medium-sized international regulatory
compliant units.
The standard of production practices followed in
Karnataka are way ahead of GMP compliance by bagging clearances from
regulatory agencies like the US Food and Drug Administration (FDA), UK
Medicines and Healthcare Products Regulatory Agency (MHRA) and ANVISA
(National Health Surveillance Agency, Brazil).
According to
Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA),
there is a high level of awareness about the current good manufacturing
practices among the units. The state’s pharma industry is also known to
generate exports earnings to the tune of around Rs.3,000 crore ending December 2010 which calls for stringent quality production practices to be maintained.
The
State drugs control department has a team of inspectors and assistant
drug controllers representing the 36 Circles to carry out inspections on
a regular basis. The constant vigil of plants by the drugs department
is also supported by regular maintenance of units in ensuring compliance
with GMP, stated Dr Jagashetty.
There are instances of some
pharma plants which have not adhered to GMP. These units were issued
stop production orders and eventually the licenses were cancelled. A few
units which were unable to comply have shut down operations. These are
Mysore Pharmaceuticals and five others.
“In order to sustain the
highest standards in manufacturing practices, we need to infuse quality
production norms and the practice of frequent inspections at the
manufacturing facilities,” stated Dr Jagashetty.