Maha FDA urges state govt to include provision of sale licence for ayurvedic drugs in D&C Act to control spurious medicines
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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