Pondicherry, which has been recently in the news regarding violation of
122E Drug & Cosmetic Rules, was found to have approved the highest
number of fixed dose combinations without the prior approval of the Drug
Controller General of India (DCGI) in the past.
According to the
information gathered by the Union Health Ministry, of the total 23 such
cases of approvals to FDCs, Pondicherry has reported as many as 8
cases. The Centre had fixed October 1, 2012 as the cut-off date for
implementing the rule to get prior permission by the state authorities
from the DCGI for approving FDCs.
After Pondicherry, Uttarakhand
was found to have sanctioned five FDCs while Maharashtra, Madhya Pradesh
and Himachal Pradesh reported two each cases. Goa, Tamil Nadu, Haryana
and Union Territory of Daman and Diu sanctioned one FDC each. Out of
these, 11 were approved during 2011 and the rest during 2012, as per the
information.
“As many as 23 cases of new FDCs , considered as
new drugs, were also found to be licenced by State Licensing Authorities
(SLAs) without approval of the DCGI . In all such cases, the office of
DCG (I) took up the matter with respective SLAs for necessary action,”
according to official sources.
“The State Drug Controllers have
been requested in the Drugs Consultative Committee meeting to ensure
that new drugs and FDCs are not permitted without approval from the
office of DCG (I) and the drugs prohibited by the Central Government are
withdrawn from the market with immediate effect. States have also been
advised to strengthen their infrastructure for better enforcement and
develop vigilance mechanism over the drugs moving in the market,”
sources added.
On October 1, 2012, the Central Government issued
statutory directions under Section 33 P of the Drugs and Cosmetics Act,
1940 to all State/UT Governments to instruct their respective drug
licensing authorities to abide by the provisions prescribed under the
Drugs and Cosmetics Rules for grant of manufacturing licenses for the
drugs falling under the definition of the term “new drug” and not to
grant licenses for manufacture for sale or for distribution or for
export of such new drugs, except in accordance with the procedure laid
down under the said rules without prior approval of the DCG (I).
Recently,
the health secretary to the government of Pondicherry had issued
show-cause notices to 20 pharmaceutical manufacturing companies
operating in region for violation of provision of 122E of the Drugs
& Cosmetics Rules following a probe by the Government on the alleged
nexus between a former official and a section of the manufacturers.
Source: Pharmabiz
