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Ayush dept issues draft notification on prefix-suffix amidst industry opposition
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Suja Nair Shirodkar, Mumbai
October 28 , 2014
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In spite of strong opposition from the industry, the Department of
Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (Ayush)
recently issued a draft notification banning prefix and suffix for 3(a)
drugs as well as preventing resemblance and mimicking names for 3(h)
formulations.
It is understood that the government for some time
had been mulling over the implementation of the newly inserted sub-rule
(1B) and sub-rule (1C) after the sub-rule (1A) in rule 157 of the Drugs
and Cosmetics Act. Through the notified draft sub rule 1B, the
government plans to curb the manufacturers from using any prefix or
suffix with the name of any Ayurveda, Siddha or Unani tibb drug falling
under clause (a) of Section 3 of the Act, except as described in the
authoritative books specified in the First Schedule to the Act, amid
stiff resistance.
Similarly the draft notified that under (1C)
the names of any Ayurveda, Siddha or Unani tibb drug falling under
clause (a) of section 3 of the Act shall not be used for naming any
patent or proprietary medicine falling under these systems of medicine
referred to in sub-clause (i) of clause (h) of the said section.
As
per the Drugs & Cosmetics Act (D&C) 1940, the drugs Sin
traditional medicine covering Ayurveda, Siddha and Unani systems are
licenced either under 3(a) category when the formulations are made as
per the text, or under 3(h) category, when the formulations are
essentially made using the ingredients of formulae from the schedule
texts.
The draft also states that notwithstanding the period for
renewal of licence provided in rules 156 and 156A, the licensee of the
Ayurveda, Siddha or Unani tibb drug, which is not in conformity with
sub-rules (1B) and (1C), shall seek renewal of the license with
appropriate name of the drug within a period of one year from the date
of commencement of the Drugs and Cosmetics (Second Amendment) Rules,
2014. This comes with a condition that this rule shall not be
applicable to any batch of Ayurveda, Siddha or Unani tibb drugs
manufactured prior to the date of commencement of the Drugs and
Cosmetics (Second Amendment) Rules, 2014.
The government has
already asked the stakeholders to immediately send in their objections
or suggestions on the same for further proceedings. Interestingly,
according to a highly placed source from the industry, this move from
the government comes in the wake of vehement opposition from the
industry on this matter.
In fact the industry, fearing huge
setback to its growth, had been putting a tough fight with the
government by not only resisting the ban of prefix and suffix for 3(a)
drugs as well as preventing resemblance and mimicking names for 3(h)
formulations, but demanding omission and nullification of the newly
inserted sub rule from the Drugs and Cosmetics Act (D&C Act)
altogether.
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