[india-drug] Licenses issued for combination drugs

[Raj Vaidya <pharmhin@sancharnet.in>]

Licenses issued for combination drugs

Licenses issued for combination drugs after May 2002 to be withdrawn,
industry may lose Rs 300 cr sales
Monday, June 28, 2004 08:00 IST 
P B Jayakumar, Chennai

Indian pharmaceutical industry stand to lose about Rs 300-crore worth
of business annually if the central drug control authorities go ahead
with the proposed order asking state drug authorities to cancel
licenses issued for thousands of irrational combinations after May
2002.

According to informed sources, state drug controllers had granted
permissions for the manufacture of several brands of irrational
combinations in the anti-diabetic, psychotropic and cardiac segments
after May 2002. Industry sources point out that as many as 30 to 40
companies have invested heavily for setting up manufacturing facilities
and several lakhs of rupees for promoting those brands. All these were
done after getting the approvals from the drug authorities of states.
Now these units are penalized for lack of well define rules in issuing
drug licenses, felt the sources.

Pharmabiz learnt that Ashwini Kumar, the Drug Controller General of
India has communicated to the industry leaders who met him in Chennai
that the center would strictly go ahead with the move to cancel the new
drug state licenses issued after May 2002, at an informal meeting
attended by some of the senior drug control officials in South India
and industry leaders in the region.

Sources said the Drug Consultative Committee (DCC), had recently
observed many drug controllers were misinterpreting the rules to
sanction licenses for many irrational combinations, which demand
elaborate surveillance, and even for claims without adequate support
data to prove safety and efficacy.

The DCC also had recommended the government to direct the state drug
authorities to cancel all the state licenses issued after May 2002. As
per this, the state drug controllers would be directed to inform the
DCGI on the new drug approvals after the period, besides the Union
Health Ministry informing the respective state health directorates to
direct their drug controller to withdraw the licenses against the
rules.

Sources pointed out that said the DCGI had issued an order in May 2002
directing the state drug controllers not to grant any manufacturing or
marketing approval for any new drug as that power is only vested with
the DCGI. According to the rules, any new drug requires sanction from
the DCGI for manufacturing and marketing in the first four years of
introduction in the country. However, the DCGIs office had then
legalized many such licenses issued before May 2002, noted the sources.




Raj Vaidya, M.Pharm,
Community Pharmacist,
Hindu Pharmacy,
Cunha Rivara Road, P.B.No. 149,
Panaji - Goa - India 403001.
Tel : 91-832- 2223176, 2432903 (O), 2463926 (R).
Email : pharmhin@sancharnet.in 


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