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AAPRA
Manufacturing of Ayurvedic herbs and herbal formulas in India
There
are more than 8500 manufacturers of Ayurvedic formulas
in the country. Ten firms have a
turn over of Rs. 50 crores (US $ 5 million) annually. Twenty five firms have an annual turn
over between Rs. 5-50 crores (US $1 to 10 million ), 965 firm have a turn over between Rs. 1-5
crores (less than US $ 1 million) and the remaining are very small firms
with an annual turn over of less than Rs.1 crore. The market share of
Ayurvedic drugs is around Rs. 3,5000 million (US $ 700 million).
At present there are more than 8000 licensed
pharmacies manufacturing Ayurvedic drugs in the country. There is a Mumbai
based Ayurvedic Drug Manufacturer’s Association which can be contacted for
further details about issues related to Ayurvedic drug manufacturing.
Manufacturing
of Ayurvedic drugs except in accordance with the prescribed standards is
prohibited. It is essential to obtain a license from the licensing
authority to manufacture Ayurvedic drugs. Separate licensing is required
for each of the manufacturing premises maintained by the manufacturer.
Manufacturing activity can also be undertaken through a loan license. For
drug manufacturing it is necessary to maintain a certain level of hygiene
and optimum manufacturing conditions. These conditions are specified in the
Schedule-T of the Act (mentioned under the Schedule to the rules). On 23rd June 2000
an amendment was made in the above act to specify Good Manufacturing
Practices (GMP) for Ayurveda, Siddha and Unani drugs. It is notified to
ensure that raw materials used in
the manufacture of drugs are authentic, of prescribed quality and are free
from contamination, 2) drugs are manufactured according to standard
conditions, 3) that adequate quality control measures are adopted and 4)
the manufactured preparations released in to the market are of acceptable
quality.
Indian
System of Medicine Manufacturing Industry is in the process of a technical
up grade to comply with GMP
norms prescribed by The Government of India. To achieve the objectives
listed above, each licensee is expected to evolve methodology and
procedures for following the prescribed process of manufacture of drugs,
which should be documented as a manual and kept for reference and
inspection. However, teaching institutions and registered qualified
Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense
to their patients and not selling such drugs in the market are exempted
from the purview of this practice. There are two parts in it. Part-I
contains specification regarding the maintenance of factory premises and
Part- II contains the list of machinery, equipment and minimum
manufacturing premises required.
For the implementation of drug testing provisions under the Drugs
and Cosmetics Act, 1940 and Rules 1945 it is necessary to evolve
Pharmacopoeia standards. At present Pharmacopoeia standards are available
for 258 Ayurvedic herbs. Standards
for 654 Text formulations have been published in the Ayurvedic Formulary of
India.
The Department of Indian system of Medicine (ISM) is developing additional
pharmacopoeia standards through pharmacopoeia Committees. Three volumes of Part I of the
pharmacopoeia called Ayurvedic Pharmacopoeia have been published containing
258 monographs. The target is to cover 600 single herbs to be included in
the pharmacopoeia.
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