Certain cases of manufacturing and
marketing of banned/ unapproved drugs have been reported in the country. The
Government has taken action against the offenders. The Central Drugs Standard
Control Organization (CDSCO) had conducted raids in 2011 in and around Delhi
and in Mumbai to check the withdrawal of the drugs Gatifloxacin, Tegaserod and
Rosiglitazone after these were prohibited by the Central Government under the
provisions of the Drugs & Cosmetics Act, 1940 by notification in the
Gazette of India. In 29 shops, banned drugs were found. Action was initiated in
those cases as per the provision of the Drugs and Cosmetics Act, 1940.
Twenty three cases of new Fixed Dose
Combinations (FDCs), considered as new drugs were also found to be licenced by
State Licensing Authorities (SLAs) without approval of the Drugs Controller
General (India) [DCG(I)]. In all such cases, the
office of DCG (I) took up the matter with respective SLAs for necessary action.
State / UT-wise information in this regard is not maintained centrally.
However, during 2011, 27 cases in Delhi and 2 cases in Rajasthan were detected
and action was initiated for sale of banned drugs. As far as the sale of
unapproved Fixed Dose Combination (FDC) drugs is concerned the following
information as available:
List of Fixed Dose Combinations (FDCs) , not approved by DCG(I),
but permitted by State Licensing Authorities
Name of the State
|
No. of FDCs for which licenses
were granted by SLAs without prior
approval of DCG(I)
|
|
Puducherry
|
8
|
|
Goa
|
1
|
|
Madhya Pradesh
|
2
|
|
Uttarakhand
|
5
|
|
Maharashtra
|
2
|
|
Silvasa & Daman
& Diu
|
1
|
|
Himachal Pradesh
|
2
|
|
Haryana
|
1
|
|
Tamilnadu
|
1
|
|
Total
|
23
|
Year wise details
|
Year
|
No. of cases
|
|
2011
|
11
|
|
2012
|
12
|
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drugs prohibited by the Central Government are withdrawn from the market with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.
On 1st October, 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 i.e. without
prior approval of the DCG (I).
This was stated by Sh. Ghulam Nabi
Azad, Union Minister for Health and Family Welfare in a written reply to the
Lok Sabha today.
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MV/GM