State FDA scrutinises cases of 23 wholesalers related to violation of conditions of licence
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Shardul Nautiyal, Mumbai
December 26 , 2014
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Maharashtra Food and Drug Administration (FDA) is in the process of
scrutinising 23 cases of wholesalers from Mumbai and Thane with
reference to violations of conditions of licence as stipulated in Rule
65 of Drugs and Cosmetics Rules, 1945.
The state had earlier
served show cause notices to the wholesalers from Thane and Mumbai
division related to violation of conditions of licence.
According
to officials, show cause notices were served to the drug wholesalers
for their explanations. Cases of violation under scrutiny are 13 from
Thane division and 10 from Mumbai on the inspections carried over a
period of past few months. Stockists were being inspected for compliance
to schedule 65 of Drugs and Cosmetics (D&C) Act, 1940 and Schedule 5
of Drug Price Control Order (DPCO) - 2013.
FDA had recently
cancelled licences of stockists for violating the conditions of licence.
FDA has also issued stop sale notice on the products and instructed
hospitals to stop use of the products.
Informs S T Patil, joint
commissioner, FDA, "The crackdown on the errant wholesalers is an
ongoing exercise considering the fact that until last year unfair
practice of constraining the supply of medicines by a handful of drug
dealers was rampant."
FDA started the drive to inspect licences
of 18,000 drug wholesalers in the state from July, 2014 onwards to
detect malpractices related to violations of conditions of licence.
Ever
since the FDA intensified its drive against people stocking and selling
drugs illegally, FDA had also filed FIRs against four such people at
Dongri Police Station in South Mumbai for illegally selling and stocking
medicines. According to an FDA official, action was taken against them
for violating the conditions of licence under Section 18 of the Drugs
and Cosmetics Act, 1940.
The arrested persons were also selling
prescription drugs at exhorbitant prices in contravention to DPCO-
2013, Section 7 of Essential Commodities Act (EC Act) and Drugs and
Cosmetics Act.
The state as of today has 18,000 wholesalers
including those who export and import. Out of which, there are around
4,000 stockists who supply to the retail trade.
The duties of a
drug inspector for inspecting the premises of a licenced drug wholesaler
are prescribed under Rule 51(1) of the D&C Rules, 1945. It empowers
the drug inspector to inspect, not less than once a year, all
establishments licenced for the sale of drugs within the area assigned
to him, to satisfy himself that the conditions of the licences are being
observed and to make such enquiries and inspections as may be necessary
to detect the sale of drugs in contravention to the Act.
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