THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)
(a)to(f): A statement is laid on the Table of the House.
STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 352 FOR 3RD DECEMBER, 2010
Some State Licensing Authorities (SLAs) have been granting licenses in the past for
manufacturing of new Fixed Dose Combinations (FDCs) without the required approval from the
Drugs Controller General (India) [DCG (I)]. These new FDCs are considered New Drugs under
the provisions of the Drugs and Cosmetics Rules, 1945 and the SLAs are required to seek
prior approval of the DCG® before issuing licenses for them. The matter was deliberated
and discussed with the SLAs by the DCG(I) on many occasions in different forums. The Ministry
of Health & Family Welfare has also issued statutory directions under Section 33(P) of
Drugs & Cosmetics Act, 1940, to all State Governments on 20.7.2000 and again on 6.5.2004,
to advise their SLAs to refrain from issuing such manufacturing licenses without the
mandatory approval from the DCG(I). Further, to introduce more clarity on the requirement
of the written approval from Drugs Controller General (I) for all such products falling
under the purview of New Drugs, Rule 71 and Rule 75 of the Drugs and Cosmetic Rules, 1945,
were also amended in May, 2005.
In the year 2007, the office of DCG (I) prepared a list of 294 such FDCs which was
communicated to the State Drugs Controllers on 14.8.2007 asking them to take necessary action
with respect to these FDCs. However, some of the manufacturers` associations filed a writ
petition in the Hon`ble High Court of Madras and obtained an order of stay dated 14.11.2007
against all further proceedings in the matter. The DCG (I) then issued a statutory direction
vide his letter dated 28.11.2007 to all the State Drugs Controllers under the provisions of
Section 33P of the Drugs and Cosmetics Act, 1940, asking them to comply with the decision
taken in the meeting dated 26.10.2007 of the Drugs Consultative Committee, a statutory
committee of Central and States` drugs regulators, including suspension of licenses of
these FDCs under reference and also not to issue any further licenses for such drugs.
However, the Hon`ble High Court of Madras again granted the stay by its order dated
4.12.2007 on the above direction. The matter is subjudice.
There is no report of any of unapproved drug formulation withdrawn / restricted in some foreign
countries but available in the country. Similarly, there is no unapproved anti-cervical cancer
vaccine reportedly available in the market.
Any drug prohibited under the provisions of the Drugs & Cosmetics Act, 1940, is not permitted
to be imported, manufactured or sold in the country, which is punishable under the provisions
of the said Act.
