1. DTAB proposes to waive local drug trials
for new drugs
The DTAB, the apex drug safety authority, has proposed amendment
to the D&C Rules to permit exemption for New Drugs already
marketed in well-regulated countries like United States of America,
European Union etc. through credible PMS mechanism, from local
clinical trials in India. As a result, the existing requirement
under D&C Rules to conduct Phase III clinical trial for the new
drugs approved in other countries stand modified. Further, DTAB has
opined that the experts in the specific therapeutic area must
evaluate the safety, efficiency and efficacy of the new drugs.
The recommendation by DTAB is in line with the Prof. Ranjit
Choudhury committee report which suggested that drugs marketed in
well-regulated countries for a period of 4 years may be granted
marketing license subject to strict PMS for 4-6
years. However, the DTAB panel opined that the period of 4
years may be waived subject to the condition as to availability of
alternative therapy or in national health care emergencies. In
consonance to DTAB recommendation, the Union Health Ministry may
amend the D& C Rules and it is decided that the period of 4
years may be waived only in cases of national emergency, epidemic
and for orphan drugs for rare diseases and for which no alternate
therapy is available.
PSA view:The exemption proposed by DTAB is a
step in the right direction for the drug manufacturers as it does
away with the additional formality of repeating drug trials
However, keeping in mind the rationale behind conducting Phase III
trial for new drugs i.e., to assess the efficacy of drug when
administered to people of different ethnicities, it is recommended
that DTAB and the policy-makers must mandate a mechanism to ensure
that the new drugs introduced are effective and favorable to
the Indian population.
2. Finally guidelines for PCV system are in the
Currently, there is no specific legislation regulating PCV
activities in India. In many countries, it is mandatory for the
pharmaceutical company to have such a system in place to monitor
In order to formally set up PCV system for collection,
processing and forwarding of Adverse Drug Reaction reports
("ADRs"), Government has formed a high
level committee to prepare guidelines for manufacturers on the same
to effectively monitor drug safety.
Setting up of a PCV system was recommended in a recent meeting
with officials from the Pharmacy Council of India
("PCI") and Indian Council of Medical
Research ("ICMR"). It was suggested that
the manufacturer or applicant should have a PCV system in place for
collection, processing and forwarding of the ADR report. This,
according to official sources, has been done in consideration of
the proposal to amend provisions relating to post marketing
surveillance under Schedule Y.
The existing law pertaining to post-marketing surveillance
requires that the applicant must furnish Periodic Safety Update
Reports (PSUR) to the Central Drugs Standard Control
Organization ("CDSCO"). However, it
does not specify that the applicant should have a PCV system in
place to monitor the clinical safety of new drugs after it is
introduced for marketing in the country.
PSA view:The CDSCO equivalent to the
European Medicines Agency of the European Union, DGHS, in
collaboration with Indian Pharmacopeia Commission
("IPC") runs a
nation-wide Pharmacovigilance Programme
("PVPI"). IPC monitors the execution of
the PVPI related activities in India. CDSCO is vested with the
powers to approve new drugs and clinical trials in the country. It
also lays down the standards for drugs, controls the quality of
imported drugs, coordinates with state drug control organizations
and provides expert advice to bring about uniformity in the
enforcement of the Drugs and Cosmetics Act, 1940 and Rules 1945.
Several Indian drug manufacturers conduct PCV of their drugs and
CDSCO has its designated centers across the country which conduct
PCV; however, the private players hardly report PCV to these
centers as the same is not yet mandatory. With new PCV mandate in
the pipeline, we can only expect better vigilance of drugs!
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