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Maha FDA urges state govt to include provision of sale licence for ayurvedic drugs in D&C Act to control spurious medicines
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Shardul Nautiyal, Mumbai
May 24 , 2019
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Following its proposal to the state government to mandate issuance of
sale licence for ayurvedic drugs, the Maharashtra Food and Drug
Administration (FDA) has urged the state government for inclusion of the
provision of “Licence for the sale of Ayurvedic drugs”, in the Drugs
and Cosmetics (D&C) (Maharashtra Amendment) Act to effectively
control spurious drugs sale.
Currently, the state FDA has no
control on ayurvedic drugs beyond registering manufacturers. Under the
existing norms, FDA has the power to seize spurious cosmetic or Ayurveda
products but has no authority for prosecuting retailers found selling
them.
The state regulator in its ongoing crackdown for
non-compliance to Drugs and Magic Remedies (Objectionable Advertisement)
Act (DMR Act) 1954 revealed that ayurvedic drugs were mixed with
allopathic medicines in contravention to the provisions of the DMR Act,
1954.
Maharashtra also submitted reports of action taken for
non-compliance to the state government seeking to make ayurvedic sale
license mandatory. The state has 600 Ayurveda licensed manufacturers,
with 50 medium or large scale manufacturers and the remaining
small-scale manufacturing units.
DMR Act seeks to curtail
undesirable advertisements pertaining to drugs and magic remedies
because advertising is considered to encourage self medication of
harmful drugs. The Act lists the diseases and disorders in respect of
which advertising is banned under Section 3 of the DMR Act.
Based
on the cases detected recently, the state regulator had last year
launched around 78 prosecutions for violation of DMR Act 1954 under the
provisions of Section 3(d) and Section 4.
Says Maharashtra FDA
Commissioner Dr Pallavi Darade, “The state drug regulator has written to
the state government to mandate sale licence for ayurvedic medicines to
control spurious drug supplies. The matter is under consideration of
the state government and is in the final stages of getting reviewed and
approved.”
As per the current provisions, each ayurvedic
manufacturer must have a space of 1,200 square feet for production of
drugs, approved machinery, an ayurvedic doctor and technician to monitor
the procedure.
The proposal to mandate ayurvedic sale licence
will also require amendment in the D&C Act to register retailers. A
similar proposal was sent by the Maharashtra FDA in 2017 to register
cosmetic retailers. The idea behind both proposals is to allow state FDA
to regulate supply chain and sale of these drugs.
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