Page 42 - A&A Patents&Design Rewind-2016
P. 42
NOTIFICATIONS UNDER SECTION 26A OF
THE DRUGS AND COSMETICS ACT DECLARED
LEGALLY UNTENABLE does not require the satisfaction thereunder of the
Central Government to be in consultation with or
454 petitions were filed against 344 on the aid, advice or recommendation of the DTAB
Notifications of the Government of India and/or the DCC or after having the requisite tests
dated 10th March 2016, all in exercise carried out from the Central Drugs Laboratory but
of power under Section 26A of the Drugs and a mere absence of the said words from Section 26A
Cosmetics Act, 1940 (Drugs Act) prohibiting the would not mean that Section 26A is to be read in
manufacture, distribution and sale in the territory isolation.
of India of drugs 344 Fixed Dose Combination
(FDC) Drugs. The petitions were declared legally As per the decision, the functions to be performed
untenable. by the Central and the State Governments under
the Drugs Act are not administrative, but largely
Section 26A of the Drugs Act, in exercise of powers technical, and therefore the Drugs Act has devised
where under the Central Government issued the the machinery for advising the Central and the State
impugned Notifications, is as under:- Governments on such technical matters arising out
of the administration of the Act and to carry out
-26A. Power of Central Government to prohibit the functions assigned to them. Merely because the
manufacture, etc., of drug and cosmetic in powers vested in the Central Government vide
public interest.— Without prejudice to any other some other Sections of the Act expressly provide
provision contained in this Chapter, if the Central for exercise thereof on advice of or in consultation
Government is satisfied, that the use of any drug with the DTAB and/or the DCC does not take
or cosmetic is likely to involve any risk to human away from the wide language used in Sections 5
beings or animals or that any drug does not have and 7, while prescribing the purpose of constitution
the therapeutic value claimed or purported to be of the DTAB and the DCC, to advise the Central
claimed for it or contains ingredients and in such quantity Government on technical matters arising out of
for which there is no therapeutic justification and that in administration of the Act and to carry out other
the public interest it is necessary or expedient so to do, functions assigned to the Central Government by
then, that Government may, by notification in the Official the Act.
Gazette, [regulate, restrict or prohibit] the manufacture,
sale or distribution of such drug or cosmetic.
The question raised in the Petition was whether The provision in the Drugs Act for constitution of
the Central Government is entitled to exercise the the DTAB and the DCC is to ensure institutional
power under Section 26A without consulting integrity and compliance of public law principles
or even involving the Drug Testing Advisory in discharge of functions and exercise of power
Board (DTAB) and the Drug Control thereunder. Not only did the legislature, in the
Committee (DCC). Another pertinent question Drugs Act, vest in the Central Government
was whether the Central Government can exercise powers to be exercised thereunder, but at the
said power in consultation with and on the advice same time it also constituted the DTAB to advice
and recommendation of another Committee, the Central Government on technical matters
composed of technical persons alone, and arising in the administration of the Drugs Act and
constituted by the Central Government. to carry out other functions assigned to the Central
The Court held that, undoubtedly, Section 26A Government by the Act and the DCC as also to
42 | Patents & Design
