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Pharma industry seeks PMO intervention to resolve gelatin capsule replacement issue
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Laxmi Yadav, Mumbai
July 29 , 2017
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The pharmaceutical industry has sought intervention of prime minister
office (PMO) to resolve the long pending issue related to replacement of
gelatin capsule with cellulose based capsule which is of plant origin.
Pharmaceutical
industry bodies viz. Indian Drug Manufacturers' Association (IDMA), PHD
Chamber of Commerce and Industry (PHDCCI) called on principal secretary
to PMO Nripendra Mishra recently in New Delhi and apprised him of
disadvantages and infeasibility of changing over from gelatin capsules
to cellulose capsules. They appealed to Mishra to intervene and let
pharmaceuticals and medicines be developed totally on scientific basis
and not on sentiments.
The proposal to replace gelatin capsules
with cellulose capsules originates from the concept of vegetarianism vs
non-vegetarianism. Neither industry nor people will benefit from this
change over, opined PHDCC.
PHDCC having members contributing to
95% of gelatine manufactured in India in its representation to Mishra
stated that gelatin capsules have been in use more than a century across
the globe. So far no technical evidence of gelatin capsules suggested
that its harmful for human consumption. Across the globe over 95% of
capsule formulations are gelatin capsules and even among the rest 5%,
hydroxypropylmethyl cellulose (HPMC) is primarily used for nutraceutical
formulations. In India only around 2% capsules are HPMC based and
almost all of them are nutraceuticals.
No cellulose capsules are
used for products such as antibiotics, oncology, anti-infectious,
painkiller and other medicinal categories. Nor have any tests been
carried out by the DCGI in India whether such medicinal products would
maintain their stability, bio-availability, bio-equivalence and other
properties if filled in cellulose capsules, it said.
The
Pharmacopoeias of the US, European Union, Japan, Australia, South Africa
and India etc have stated that gelatin capsules are safe. Drugs
Technical Advisory Board on May 13, 2016 ruled that unlike food, drugs
are not taken by choice but re prescribed by the doctors to save lives
and making them as vegetarian or non vegetarian origin is not desirable.
The PHDCCI has also submitted a representation to the Expert
Committee set up by Ministry of Health and Family under chairmanship of
Prof CK Kokate to address all the technical issues pertaining to
replacement of gelatin capsules with cellulose based capsules for
encapsulation of drugs.
IDMA secretary general Dara Patel in the
representation to Mishra stated that gelatin capsules have been in use
for over 100 years. It has been found to be very safe for human
consumption and accordingly it has been accepted by regulators all over
the world. Thousands of crores have been spent on establishing the
quality, viability and economics of gelatin capsules. There have been no
adverse reports of gelatin capsules.
“We are totally
self-sufficient with the raw materials for gelatin capsules. We will be
totally dependent on imports of raw materials for cellulose capsules.
The safety and efficacy of cellulose capsules cannot be guaranteed.
Members are concerned that even after approvals, few long term studies
may show adverse reports and they may not want to take the
responsibility for that. Today we manufacture 120 billion gelatin
capsules compared to only 2 billion cellulose capsules. Cellulose
capsules are 2-3 times expensive compared to gelatin capsules. This
would increase the cost of drugs to the patients. Huge investment in
plant and machinery would be required to adopt cellulose capsules,”
Patel said.
If gelatin capsules would be substituted with
cellulose capsules, there would be a panic situation in the industry
apart from uncertainty and anxiety. Hence IDMA appealed to the
government to continue to allow use of gelatin capsules to ensure
availability of safe, efficacious and affordable drugs to the patients.
Mishra considering views of the industry representatives finally agreed that both types of capsules should co-exist.
It
may be noted that the Directorate General of Health Services vide
notice dated June 02, 2017, had sought views of various stakeholders to
address all the technical issues pertaining to replacement of gelatin
capsules with cellulose based capsules for encapsulation of drugs.
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