Cosmetics Imports Allowed only through 14 Specified Ports
[CBEC Circular No. 08 dated 26th March 2010]
Subject:
Import of Cosmetics under the Drugs and Cosmetics Act, 1940 and Rules made thereunder
I am directed to
invite yourattention to the Board’s Instructions vide
F.No. 450/08/ 2007-Cus.IV
dated 22ndJanuary, 2007 regarding import of drugs
under Chemical or generic name and permitting its clearance through specified
places under the Drugs and Cosmetics Rules, 1945.
2. In terms of Rule 133 of the Drugs and
Cosmetics Rules, 1945, no cosmetics shall be imported into India except through
the points of entry specified in Rule 43A of the said Rules. Further,
under Schedule “D” to the said Rules read with Rule 43, an exemption has been
provided to certain categories of substances from the restrictions under
Chapter III of the Drugs and Cosmetics Act, 1940 relating to import of Drugs
and Cosmetics. Therefore, a doubt has arisen as to whether import of cosmetics
could be permitted through any port in the country under the Drugs and
Cosmetics Rules, 1945. The matter was taken up with the Drugs Controller
General of India (DCGI) for obtaining necessary clarification.
3. The DCGI has clarified the aforesaid issue. It
is stated by them that Rule 133 of the Drugs and Cosmetics Rules limits the
import of cosmetics through the points of entry specified under Rule 43A.
However, under Schedule “D” to the said Rules, an exemption has been provided
for substances not intended for medical use from the provisions of Chapter III
of the Drugs and Cosmetics Act and Rules made thereunder.
The Act provides for separate definition for ‘cosmetic’ and ‘drug’ under
Sub-Section 3(aaa) and 3(b),
respectively. Hence, they have stated that the phrase ‘substances not intended
for medical use’ would only relate to substances which would otherwise fall
under the definition of the term ‘drug’ under section 3(b) of the Act, but are
being imported not for medicinal use or for some other purposes or are of commercial
quality and are being labelled indicating that they
are not for medicinal use. Accordingly, they had clarified that this
exemption does not extend to other categories of products defined under the Act
including cosmetics. For the purpose of import of cosmetics, provision of
Rule 133 therefore remains applicable.
4. Accordingly, import of cosmetics at points of entry
/ places other than those specified under Rule 43A may not be permitted as per
the provisions of the Drugs and Cosmetics Rules, 1945. The points of entry have
been specifically mentioned in Rule 43A such as Chennai, Kolkata, Mumbai, Nhava Sheva, Cochin, Kandla,
Delhi, Ahmedabad, Hyderabad and Ferozepur Cantonment,
Amritsar, Ranaghat, Bongaon
and Mohiassan Railways Stations. If the imports are
noticed through Customs stations, other than the one notified as mentioned
above, then necessary action may be taken for non-compliance of the Drugs and
Cosmetics Rules in respect of such imports.
5. Board’s Instructions vide
F.No.450/08/2007-Cus.IV dated 22.1.2007 shall apply for import of drugs. In
case of import of drugs noticed at places other than those that have been
notified under the above Rules, the instruction communicated by Drugs
Controller General of India, Directorate General of Health Services vide
No.16/6-DC dated 15.6.2007 may be followed.
6. These instructions may be brought to the
notice of all concerned by way of issuance of suitable Public Notice / Standing
Order.
7. Difficulties, if any, in implementation of the
Circular may be brought immediately to the notice of the Board.
F. No.450/182/2009-Cus.IV