The Maharashtra Food and Drug Administration (FDA), which plays a major
role in determining the national policy on the import and local
manufacture of pharmaceuticals, has initiated a number of steps to
spruce up its activities.
While it has accelerated its
recruitment process and also strengthened drug seizure activities, it
is planning to organise a sensitisation programme on Schedule L-1 for
small scale manufactures in Mumbai and Thane soon. It has also started
construction of a three-storey building on its 2.5 acre land in
Aurangabad.
The activitiesf FDA has got a booster shot with the
new FDA commissioner Seema Vyas who has taken charge recently. Vyas who
is the first women FDA commissioner, is giving special emphasis on
strengthening programmes and policies of FDA.
Vyas has
accelerated the recruitment process so that it will enable the agency to
carry out its mission to protect and promote public health. FDA is in
the process of recruiting 95 drug inspectors according to P R Uttarwar,
joint commissioner. It has already completed with the selection
procedure and have began further proceedings. The new drug inspectors
are likely to join the office within three months.
According to
Uttarwar, within three months all the 95 drug inspectors would be given
division -wise training and once they join, they would be assigned
duties across the state. In the last 10 years there were no recruitment
of new drug inspectors in the state. Though there are 161 posts for
drug inspectors, only 66 posts are occupied till now.
FDA is
also planning to organise a sensitisation programme on Schedule L-1 for
small scale manufactures in Mumbai and Thane in November. Through this
programme, FDA plans to spread the awareness on Good Laboratory
Practices (GLP) as per Schedule L-1.
The programme is intended
to train small scale manufacturers in Mumbai and Thane on GLP
implementation of GLP. According Uttarwar, “Knowledge of good laboratory
practices is crucial in pharma industry. It is important to follow the
new GLP requirements as per Schedule L-1 of Drug Rules which is going
to be operational soon, failing which we would be forced to cancel
licences.”
The FDA is keen that large as well as small scale
manufacturers should adhere to the new GLP requirements. However many of
the small as well as medium scale units are not on complying with
the GLP norms due to the huge investments required for upgradation of
the manufacturing facility. In fact there have been demands from some
section of the industry for postponement of the present deadline by
two years to November 1, 2012.
FDA officials informed that soon
after the completion of the sensitisation programme in Mumbai and Thane,
they would conduct similar programmes in Pune, Nashik and Aurangabad as
well.
In the meanwhile large volumes of oxytocin was seized by
the FDA in four separate raids in Pune and Thane. The captured stocks
were worth Rs 91000 from Pune and Rs 20 lakh from Thane. The team found
that oxytocin injection that were manufactured illegally was injected
on buffaloes and cows for stimulating milk release.
According to
Uttarwar , FDA had received information that oxytocin had been
administered to bovine animals like buffaloes and cows in high quantity
to increase the production of milk.
“These people were
unlawfully selling oxytocin injections to dairy farms so that they could
get more milk out of the animals. After preliminary investigation FDA
has found that these injections where manufactured illegally in Bihar
and West Bengal, Calcutta in large quantities. We have arrested four
people , three from Pune and one from Bihar where as we have filed an
FIR against an unknown person in the Thane case”, he said.