India needs a federal drug regulatory system for uniform implementation of drug laws and elimination of NSQ drugs from market: Study
A single Drug Regulatory System under a federal set-up for
the nation may solve all the drawbacks that plague the present drugs control
administrations in the central and states. It will also eliminate the pan India
presence of Not-of-Standard-Quality (NSQ) drugs which pose a challenge to
regulators all over India, a research study has found.
As a permanent solution to this technical snag, the central
and state drugs control administrations (CDSCO and state DCAs) should merge
into one single entity under the federal set up of the constitution, the study
finds.
The study on Indian drug regulatory system was carried out by
an assistant drugs control officer, Dr. Khalid Ahmed Khan, of the regulatory
department of Karnataka as part of his research work on Ph D thesis. Dr H G
Shiva Kumar, head of department of pharmaceuticals at JSS University, was
Ahmmed Khan's guide for the research. The thesis was accepted by the department
of pharmaceutics of the JSS College of Pharmacy at JSS University, Mysore and
Khalid was awarded doctorate degree.
According to his findings, for effective implementation of
the provisions of drugs and cosmetics act (D&C Act) and the Rules there
under in a uniform manner, the present parallel system of enforcement is always
a hindrance. Due to this dual regulations, the menace of Not of Standard
Quality (NSQ) drugs, spurious and adulterated drugs cannot be eliminated from
the market. The regulatory departments are unable to ensure quality of the
drugs in the Indian market. If there is a single system under a federal set up,
it will help the Indian pharmaceutical and allied industry to grow
exponentially and become a global leader within a short span of time.
Talking about the draw backs of the present regulatory
system, Dr. Khalid Khan, in a telephonic talk with Pharmabiz, said, “Today
India has a crying need to address the issue of NSQ drugs. As per data
collected from 30 states in 2017 India has over 12000 manufacturing units, but
has only 1,500 regulatory staffs. This indicates the inadequacy of the drug
regulatory system of our country. The present scenario of Indian regulatory
system is a parallel type of a set-up wherein the CDSCO and the state drugs
control administrations (state DCAs) function parallel to each other with
obvious inherent disadvantages and demerits. The important issue to be tackled
is non-uniformity in the implementation of the D&C Act and the Rules. India
lacks a single monitoring system”.
The thesis finds one lacunae in the system of regulation and
that is lack of infrastructure and manpower. This shortage has brought down the
efficiency of the central and state regulatory agencies for implementing the
drug laws. The primary responsibility of the enforcement agency is to ensure
availability of standard quality drugs to the public, but as long as these two
agencies function separately, the discrepancies that affect the system now will
continue to exist.
Dr Khalid said there were instances of irrational drug
combinations and FDCs, not approved by DCGI, flooded the Indian market due to
grant of permissions by the state licensing authorities. This is a critical
issue crippling the entire regulatory set up and it happens because of
non-uniformity in the interpretation and implementation of the drug acts and
absence of a single monitoring system.
Guidelines issued by DCGI with respect to dealing with NSQ
drugs are not uniformly implemented across the country. This is a matter of
great concern. For grant and renewal of licences for blood banks take years due
to lack of coordination between the officers of the central and state departments,
shortage of inspection staff as well as supporting staffs.
Sumant Kumar Tiwari, deputy director at Jharkhand DCA,
supporting the views expressed by Dr Khalid Ahmed Khan in his thesis, said
there are several sensitive departments functioning properly all over India and
the acts that govern them come under the concurrent list. So, a federal agency
can implement the act without leaving any loophole for corruption or violation
or offence. As regards drug laws, there should not be the provincial regulation,
but there should be a federal regulation.
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