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Kerala govt withdraws 2013 order mandating clinical trials for ayurvedic proprietary drugs, permits pilot study for licences
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Peethaambaran Kunnathoor, Chennai
January 22 , 2019
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Following direction from the central Ayush Ministry and opposition from
the Ayurveda industry, the government of Kerala has withdrawn its
September 6, 2013 order, which mandated clinical trials for patented and
proprietary Ayurveda drugs for receiving licences from the government.
In
place, the government has issued a new order making pilot study as per
the Drugs and Cosmetics Act 1940 a sufficient criterion for getting
manufacturing licences. However, the order of January 16, 2019 says that
the efficacy of the proprietary drugs has to be proven as per the
suggestions of the expert committee formed by the government in 2015.
With
this new order of the Kerala government, rule for clinical study for
Ayurveda drugs has ceased to exist in the country. Kerala was the first
state taken steps to introduce the rule and it was also the last one to
withdraw the order mandated for clinical study. No other state in India
has made clinical study as a compulsory part for licence application
following Central rule.
The new order, which was issued by the
government on January 16 this year, clarifies that the licensing
authority for ayush (SLA) can now issue licences for patented and
proprietary Ayurveda drugs based on provisions stipulated under Section
158 (B) II (B) of the drugs and cosmetics rules 1945. Instead of
clinical trials mandated in the 6/9/2013 order, the manufacturers can
now go with pilot studies as specified in the drugs and cosmetics act to
avail permit from the department of Ayurveda.
In the year 2010,
the union ayush ministry had brought a new rule by amending the D&C
Act making clinical study compulsory for proprietary medicines,
especially for those products manufactured for export purpose. Based on
this rule, the government of Kerala constituted an expert committee to
work out on modalities for the clinical trials. Although the expert
committee recommended three institutions for conducting clinical study,
not all of them undertaken any project or supported clinical study.
Further, the manufacturers also opposed the government rule and they
approached the union government demanding review of its decision. They
wanted the government to allow them go with the pilot study as specified
in the D&C Act. Considering their request, the union ayush ministry
issued a revised order in July last year making pilot study as the
compulsory part for applying licences. The ministry had also directed
all the state ISM departments to issue licences based on its revised
order. But the Kerala government was reluctant to change its stance of
clinical study.
The delay in reviewing the state government’s
decision halted issuance of licences from the Kerala Ayurveda department
resulting the industry being put in trouble. Manufactures association
held several round of talk with the government and finally the
government has now opened the door for pilot study for all ayurvedic
proprietary products in Kerala.
Welcoming the decision of the
government permitting manufacturers to continue with pilot study for the
proprietary drugs manufactured on textual rational, Dr D Ramanathan,
president of Ayurveda Medicine Manufacturers Organisation of India
(AMMOI), said the whole Ayurveda sector in Kerala is now obliged to the
state government as more and more research based medicinal products can
be manufactured for various chronic ailments. The permission for pilot
study will also help the small scale units in the manufacturing sector
and the state can market quality products to other parts of the country
from Kerala, he said.
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