|
DCGI to fast-track regulatory approval to combination drugs for HIV, hepatitis B & C recommended for concomitant use by WHO
|
|
Ramesh Shankar, Mumbai
March 27 , 2017
|
|
|
The Drugs Controller General of India (DCGI) will fast-track regulatory
approvals relating to combination products for HIV (antiretroviral),
hepatitis B & C, which are recommended for concomitant use by World
Health Organization (WHO).
Earlier, the issue of regulatory
approval relating to combination products for HIV (ARV), hepatitis B
& C was discussed in 33rd meeting of the Apex Committee held on
21.02.2017 under the chairmanship of secretary, ministry of health &
family welfare. The committee agreed with a course of action to be
followed with a view to fast-track regulatory approval relating to
combination products for HIV (ARV) and hepatitis B & hepatitis C in
the public interest.
As per the action plan, the manufacturers
should apply for bioequivalence (BE) NOC and New Drug application
simultaneously to ensure early availability of these important
combination products for Indian population. Many of these combination
products, recommended in WHO guidelines for concomitant use, may not
have been approved internationally in combination but may have been
approved individually. However, given the risk-benefit and
recommendations by WHO the requirement of generated data may be waived
based on the fact that the product has been recommended for concomitant
use by WHO, the Apex Committee noted.
Application for BE NOC for
export of such products shall be initially made for pilot studies on
batches manufactured at pilot scale and followed by pivotal studies on
batches manufactured at pivotal scale. Manufacturers should follow the
international regulatory standards for manufacture of pilot and pivotal
scale batches mandating its equivalence. The manufacturer should ensure
adequate clinical and quality oversight on the conduct of these
bioequivalence studies.
The New Drug application may be accepted
with abbreviated data at pre-screening stage with firm
commitment/undertaking regarding submission of complete data prior to
grant of approval. The scrutiny shall be applicable to New Drugs
application only. Clinical trial waiver for such products recommended by
WHO for concomitant use may be given, as being falling under the
category of extreme urgency and under the provisions of the Drugs and
Cosmetics Rules.
This regulatory policy applies to products
recommended by WHO guidelines and Expression of Interest (Eol) for
rational combination of products used for HIV and hepatitis B & C.
For approval of drugs for hepatitis B & C in the Indian market, the
combination products should be relevant to Indian population sub types,
the DCGI said.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|