Ever since independence in 1947 there has been a
sustained policy support for the development of Indian Systems of Medicine and
Homoeopathy. Government has taken a
number of legislative and administrative measures to regulate the manufacture
and sale of Ayurveda, Siddha and Unani (ASU) drugs. There is a separate Chapter IVA which regulates the manufacture
and sale of ASU medicines in the Drugs & Cosmetics Act, 1940. Chapter IVA of the Indian Drugs &
Cosmetics Act, 1940 has provisions for regulation of manufacture and sale of
ASU drugs, packaging and labelling of ASU drugs for domestic use and export and
penalty for manufacture and sale of ASU drugs in contravention of these rules
and for misbranded, adulterated and spurious ASU drugs.
The Act is enforced through the
State Drug Licensing and Drug Control Authorities. A separate Ayurveda, Siddha and Unani Technical Advisory Board
(ASUDTAB) has been constituted by the Central Government comprising of
officials and nominees of Central Government, pharmacogonists, Phytochemists
and Members of the Ayurveda Pharmacopoeia Committee, Siddha Pharmacopoeia
Committee and Unani Pharmacopoeia Committee and representatives of teachers,
practitioners and ASU Drugs industry nominated by the Central Government to
advise the Central and State Governments on technical matters relating to
regulation of ASU drugs. The Central
Government has also constituted a Ayurveda, Siddha and Unani Drugs Consultative
Committee (ASUDCC) under the Act to advise the Central and State Governments
and the ASUDTAB on any matter for the purpose of securing uniformity though out
India in the administration of Drugs & Cosmetics Act, 1940 as it relates to
ASU drugs. Periodic meetings of these
statutory bodies are held and all technical and regulatory issues arising out
the enforcement of Chapter IVA of the Drugs & Cosmetics Act, 1940 relating
to ASU drugs are referred to these bodies for advising the Central and State
Governments. A specific law, the Drugs & Magic Remedies Act, 1954,
is also in place for prevention of objectionable advertisements & publicity
relating to certain drugs and magic
remedies for treatment of certain identified diseases and disorders.
Laying down of pharmacopoeial
standards of drugs are mandatory as per Drugs & Cosmetics Act, which was
amended in 1964 to bring under its purview Ayurveda, Siddha and Unani drugs.
For implementation of the Act and Rules thereunder, and as a first step the Pharmacopoeial
Laboratory of Indian Medicine (PLIM)
was set up in 1970 and the Homoeopathic
Pharmacopoeial Laboratory (HPL) was set up in 1975 to
facilitate drug standardization & testing of ASU drugs. In addition 13 other reputed laboratories
have been engaged to lay down pharmacopoeial standards and preparation of
monographs and for evolving Standard Operating Procedures (SOPs) for ASU
drugs. Pharmacopoeial Committees have
been constituted separately for ASU systems.
It is the responsibility of these Committees to lay down standards of
quality, purity and strength of drugs and approve drug formularies. So far, 326 monographs of Ayurveda drugs in
4 volumes, 45 of Unani drugs, 916 of Homeopathic drugs have been published.
Another 98 monographs on Ayurveda drugs are due for publication very soon.
Formularies of Ayurveda, Siddha and Unani containing 636, 248 and 745
multi-ingredient classical formulations respectively have been published to
facilitate manufacture of drugs with uniform composition and manufacturing
procedures.
Parameters adopted for Quality control &
Standardization
Ayurveda,
Siddha and Unani drugs which are mainly poly-herbal/herbo-mineral preparations
are very different from synthetic molecules of the allopathic system which are
produced under controlled laboratory conditions. Much depends on the quality and availability of raw materials of
botanical origin. Keeping this in
view, the National Medicinal Plants Board (NMPB) was established in the year
2000 with the objective of in-situ conservation and ex-situ cultivation of
quality medicinal plant raw materials.
In view of environmental pollution the NMPB is examining how best to
adopt Good Agricultural and Collection Practices for collection and cultivation
of medicinal plants for ensuring quality raw material for ASU medicines. As a large number of our forest dwellers and
small landholders are engaged in collection and cultivation, these norms have
to be adopted in a way that livelihood is not affected.
Both
traditional and modern parameters are used for quality testing and
standardization of raw materials as well as finished products. Many methods from organoleptic
standardization of drugs, chemical analysis, biological assaying for testing of
heavy metals, pesticides and microbial load have been developed for quality
control and standardization of ASU drugs.
An effort has been made to include Chromatographic fingerprint profile
as a supplementary to Ayurvedic Pharmacopoeia.
Identification of active therapeutic ingredients and marker compounds
with reference to which ASU drugs can be standardized are still evolving and
all these parameters are being added to the ASU pharmacopoeia. Pharmacopoeial Laboratories and laboratories
of Central Council for Research in Ayurveda and Siddha (CCRAS), Central Council
for Research in Unani Medicine (CCRUM), various laboratories of Council for
Scientific & Industrial Research (CSIR) and private sector institutions and
laboratories are doing a commendable job in evolving and laying down safety and
quality standards for poly-herbal/herbo-mineral preparations including plant
extracts. It needs to be emphasised
that the work of quality control and standardization of herbal/herbo-mineral
drugs is much more complex and standards are constantly evolving and this is
not only true for ASU drugs, it is equally so in other traditional systems of
medicine all over the world. While
there is a need to speed up this work and for streamlining regulatory mechanism
for ASU drugs, it will be inappropriate to term Ayurveda, Siddha and Unani
drugs industry as being completely unregulated. It needs to be kept in mind that humanity has survived on
traditional medicinal knowledge for thousands of years.
The following major initiatives have
been taken by the Central Government for ensuring safety and quality control of
ASU drugs:
(i) Good Manufacturing Practices (GMP) for
ASU drugs were notified on 23rd June, 2000 under Schedule ‘T’ of the Indian Drugs & Cosmetics Act, 1940
and Rules, 1945 which seeks mandatory compliance from the licensed
manufacturers with regard to raw-materials, manufacturing area, manufacturing
processes, record keeping, storage of raw-materials and finished products and
quality testing. State Governments and
all State Licensing Authorities have been advised vide Department of AYUSH
order dtd. 13.10.2005 to ensure strict compliance of GMP by ASU drugs
manufactures and cancel the license of non-GMP compliant units.
(ii) Provisions relating to proper
labelling, packing and conspicuous display of all the ingredients along with
the quantities contained in the formulations on the label/container or a
leaflet inserted inside the container, have been reiterated for compliance by
an order issued by the Department of AYUSH on 10.10.2005 for strict compliance
by State Drug Controllers/Licensing Authorities.
(iii) To address domestic as well as
international concerns on presence of heavy metals in ASU drugs exporters of
purely herbal ASU drugs have been directed to either conspicuously display on
the container of purely herbal ASU drugs words “Heavy metals within permissible
limits” or furnish the above certificate from an appropriately equipped
in-house laboratories or any other approved laboratories along with other
consignment papers w.e.f. 1.1.2006.
Mandatory testing for heavy metals on purely herbal ASU drugs will also
be extended for sale of purely herbal ASU drugs within the country in phases
keeping in view the testing infrastructure within the country.
(iv) The issue of safety of
herbo-mineral/herbo-metallic Bhasmas/Compounds is also being addressed by the
Central Government. A project has been
sanctioned for chemical analysis and safety studies of eight most widely used
Rasaushadhis/Bhasmas, namely, Kajjali, Rasmanikya, Nag Bhasma, Rasasindoor,
Basantkusumkar Ras, Arogyavardhini Vati, Mahayograj Guggul and Mahalaxmi Vilas
Ras by CSIR laboratories under the Golden Triangle Project within a time frame
of 18 months.
(v) Use of permissible excipients,
preservatives for increasing the shelf-life of ASU drugs has been
notified. Draft rules for expiry date
of ASU drugs have also been published in November, 2005 and a consultation
process is on for finalizing these rules.
(vi) Certain guidelines have also been issued
to State Licensing Authorities with a view to curb the mushroom growth of
irrational ASU combinations through the patent and proprietary route.
As mentioned above the issues
concerning quality control and standardization of ASU drugs are very complex
and very different from those concerning regulation of synthetic molecules
produced under controlled laboratory conditions. This is a problem which is being faced by the regulators of
traditional systems of medicine all over the world. Scientific methods and techniques for standardization and
quality control of herbal/herbo-mineral drugs are constantly evolving all over
the world. Regulators have to keep pace
with the development taking place in the field of Botany, Phyto-chemistry,
bio-chemistry. Apart from public and
private sector research institutions ASU drug industry itself is making an
important contribution in the field of evolving methods and standards for drug
standardization and quality control.
Many private sector companies in India have made a notable contribution
in the field of evolving standards and preparation of monographs on herbal
plant extracts. Ministry of Health and
Family Welfare, Department of AYUSH, apart from laying down pharmacopoeial
standards and issuing guidelines under the Drugs & Cosmetics Act and Rules
from time to time, has initiated a process of consultation between Ayurveda,
Siddha and Unani experts and experts in the field of Botany, Phytochemistry,
Bio-chemistry and representatives of ASU drugs industry for making the
regulatory framework responsive to the developments in the field of science and
technology. It is as a result of these
measures that use of techniques like Chromatographic fingerprint profiles and
use of active therapeutic ingredients and marker compounds for standardization
and quality control of herbal and herbo-mineral preparations are becoming
popular in the ASU drugs industry.
The
Department of AYUSH will, in consultation with all concerned, come out with
more detailed guidelines for licensing of classical and patent &
proprietary ASU medicines based on a product dossier system very shortly with a
view to further improve and strengthen the licensing framework for ASU
drugs.
The
Department would like to reiterate that there are regulatory mechanisms in
place for regulating standardization and quality control of ASU drugs and the
regulatory framework is evolving in response to the developments in the field
of science and technology. However, the
general public should use ASU medicines as far as possible under medical
supervision and they should be purchased on Cash Memos after proper
verification of the ingredients mentioned on the label or on the leaflet
inserted inside the container. In case
of doubt, they should consult a qualified Ayurveda/Siddha/Unani practitioner
and any contravention with the labelling provisions should be brought to the
notice of the District and State Health Authorities and the Department. ASU Drug Industry Associations should also
motivate their members to move in the direction of self regulation and
self-certification and as a first step, start voluntarily printing indications
and contra-indications of every formulation either on the label/container or in
a leaflet to be inserted in the container for educating the general public
regarding their products. All queries
to the Department can be e-mailed on adv_ayurveda@yahoo.com
or jsismh@nic.in.
SR/vk
(Release ID :14876)