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‘India’s
drug regulator can’t be in isolation’
Drugs
Controller General of India Surinder Singh speaks to K G
Narendranath on the ongoing efforts to harmonise India’s drug
regulatory systems with that of the West
INDIA’S drug regulatory
landscape has changed a lot in the last four-five years, thanks to
a clutch of legislative changes and new rules and regulations —
new good manufacturing practices through amendments to the
Schedule M of Drugs & Cosmetics Act, registration norms for
imported drugs, amendments to the Schedule Y that lays down the
protocols of regulatory assessments and approvals for
manufacturing/import of ‘new drugs’ and clinical trials, and new
norms for medical devices, to name a few. But the regulatory
machinery and systems have yet to be in sync with these new laws
for their meticulous enforcement and effective delivery of
regulatory services. Your comments.
Taking cue from a World Health Organization (WHO)
initiative, we have firmed up a plan with Health Canada, the
national regulatory authority in that country, to strengthen our
key regulatory functions and harmonise the evaluation systems with
the developed world. What is on the anvil is a tripartite
agreement among WHO, Health Canada and India’s Central Drug
Standard Control Organisation (CDSCO) to implement an
institutional development plan for CDSCO as per a road map. Last
month, joint secretary (health) and myself visited Otawa to give
final shape to a training programme in the area of licensing for
our regulatory personnel. Earlier last month, a Health Canada
mission visited India and stressed on the need to re-organise
India’s national biologicals department. A new system for
evaluation of biological products such as blood and blood
products, sera (which are crucial from a regulatory perspective)
will be operational by September.
Broadly, the objectives of the Health Canada plan is to
evaluate and improve upon the independence of regulatory
authorities, recall systems, adequacy of staff, dossier review and
the system for providing feedback on adverse effects of
immunisation from central and state levels. Two expert committees
will be set up to provide technical expertise in areas of vaccine
licensing (India is a major vaccine producer, accounting for up to
60% of the global supplies of many important vaccines) and
oversight of clinical trials. Devising common technical documents
(CTDs) for filing of various dossiers will be one component of the
programme assisted by the Health Canada. CTDs will be in
conformity with the International Conference on Harmonisation (ICH)
norms.
ICH-compliant dossiers will ensure that Indian drug companies
find it easier to get regulatory nods from Western regulators like
US-FDA once the dossiers are reviewed and approved by the Indian
regulator. This would come as a timely help for India’s generic
drug companies in their efforts to step up export sales. Also,
once CTD system is established, as the national regulator for
India we will be more equipped to expediently evaluate new drug
applications filed here on behalf of foreign companies. An
advanced computerised system for evaluation of dossiers will be
set up by September this year. The idea is to move towards
e-governance so that the reviews would be transparent and the
applicants can even check the status of their filings on-line.
By the way, we are in the process of shifting from our Nirman
Bhawan premises to a newly built, state-of-the-art facility called
Foods and Drugs Bhawan.
The central drug regulator is still poorly equipped in terms of
manpower and technical expertise. You rely heavily on state
government machinery for enforcement.
We’re adding to our human resources. Twenty new central
drug inspectors, 48 additional technical experts and many more as
supporting staff. It is true that this will not suffice. To a
certain extent, we will have to depend on the state government
machinery.
What about the plan to have a Central Drug Authority (CDA) as
the sole licensing authority for drugs?
The CDA Bill has been introduced in the Rajya Sabha and
so, it won’t lapse. The Bill is being examined by a Parliamentary
standing committee headed by Amar Singh. Since the proposals in
the Bill — like divesting the states of the power to grant drug
licences— will have wide-ranging ramifications, it is natural that
deliberations are not rapped up quickly. (Currently, the Centre—
DCGI— is the approving authority for all ‘new drugs’ as defined in
the Drugs & Cosmetics Act, vaccines, blood and blood products and
large volume parenterals. This means that the states can issue
licences only after getting the DCGI’s assent. For other products,
the states can issue licences on its own. However, many states
used to unilaterally issue licences for the products that need the
Centre’s approval as well and the CDA Bill proposes to scrap the
licensing powers of states once and for all).
There are certain practical questions pertaining to the
proposal to centralise drug licensing, like the concern over the
likely hassle of drug manufacturers needing to come to Delhi for
each licence and its renewal. We propose to address these concerns
by authorising zonal and sub-zonal offices of the central
authority (there are six such in total) to renew licences.
What will be the structure of CDA?
The authority will have a chairman at the rank of
secretary to government of India and three to five members,
assisted by the DCGI. There will be 10 divisions— regulatory
affairs & enforcement, import, new drugs and clinical trials,
biologicals and biotechnology products, pharmacovigilance, medical
devises and diagnostics, organisational services, training &
services, quality control affairs and legal & consumer affairs.
Will the Drugs Technical Advisory Board (DTAB), the statutory
body of experts, continue to exist?
No, CDA will replace the DTAB. The Drugs Consultative
Committee of state drug controllers will be re-organised by
including few experts as members.
At present, India does not permit Phase I clinical trials
(first time administration in humans) of new (potential) drug
molecules discovered in a foreign country, unless the same trials
are already done in a foreign country and results are known. This
is said to be hampering the country’s efforts to partake in global
drug R&D. Any rethink on this policy?
We are reviewing this policy. The rationale behind the
move is that we need to give fast-track approvals for drugs that
are relevant to Indian population. Even now, we are allowing Phase
I clinical trials without foreign results in case of molecules of
Indian origin. Molecules derived from R&D done abroad can be
treated on a par if it is presupposed that the potential drug
would be significant in the Indian context. The Schedule Y needs
to be amended to make this policy change. We plan to do this
shortly.
A recent statement by you of a plan to disallow marketing pleas
of generic versions if a patent is already issued evoked mixed
reactions. Won’t such a policy amount to crippling India’s generic
industry?
What we are contemplating is to pursue the middle course.
If we totally ignore (the pleas for patent linkage from originator
pharma companies), the country’s reputation is at stake. India is
reckoned to be major force in the global arena in pharmaceuticals,
as in many other fields. So, we cannot be in isolation. But we
cannot be as strict (on ensuring patent linkage) as some countries
in the West, because our strength lies in generics. We will work
out a system only after broadbased consultations with all
stakeholders.
How serious is the oft-reported issue of spurious drugs?
A recent (June 2007) study of 10,000 random samples by an
agency showed that only 3.1% of these samples can even be
“suspected to be counterfeit,” and lab tests of these suspected
samples verified that just 0.3% of the total 10,000 samples can be
said to be sub-standard (not having the active pharmaceutical
ingredient in required quantity). So, many reports are
overstatements. But that doesn’t mean that we are lax on curbing
the menace of fake drugs.
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Quality
