The Central Board of Excise and Customs (CBEC), the policy making and monitoring body relating to customs under the Department of Revenue in the Union Ministry of Finance, has clarified that the imports of cosmetics to the country should be restricted through the entry points approved for imports of drugs under the Drugs and Cosmetics Rules, 1945.

The clarification, according to the CBEC officials, has been internally circulated in the departmental institutions to weed out the existing confusion related to two different Rules under the Drugs and Cosmetics Rules, 1945.

While the Rule 133 of the Drugs and Cosmetics Rules, 1945, specifies that no cosmetics shall be imported into India except through the points of entry specified in Rule 43A of the said Rules, the Schedule "D" to the D&C Rules puts an exemption to certain categories of substances from the restrictions under Chapter III of the Drugs and Cosmetics Act, 1940 relating to import of medicines and cosmetics. The two Rules, read together, have created confusion among the customs officials whether import of cosmetics could be permitted through any port in the country.

The Board, after consulting the Drug Controller General of India (DCGI), concluded that the imports of cosmetics is limited through the points of entry specified under the Rule 43A, that is the entry points including such as ports in Chennai, Kolkata, Mumbai, Nhava Sheva, Cochin, Kandla, Delhi, Ahmedabad, Hyderabad and Ferozepur Cantonment, Amritsar, Ranaghat, Bongaon and Mohiassan railway stations. The Rule 133 of the Drugs and Cosmetics Rules limits the import of cosmetics through the points of entry specified under Rule 43A.

"For the purpose of import of cosmetics, provision of Rule 133 therefore remains applicable...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," said an internal circular of CBEC, issued recently.

Allaying the Board's doubts on the issue, the DCGI has informed that the provision to exempt 'substances not intended for medical use' from the provisions of Chapter III of the Drugs and Cosmetics Act and Rules, under Schedule D, would only relate to substances which would otherwise fall under the definition of the term 'drug' under section 3(b) of the Act. Such products has to be 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.

The definition for the term cosmetic is provided in the Drugs and Cosmetics Act separately under Subsection 3(aaa) and the exemption meant for drugs defined under Subsection 3(b) does not extend to other categories of products defined under the Act including for cosmetics, clarified the drug regulator.

The Act provides separate definition for 'cosmetic' and 'drug' under Sub-Section 3(aaa) and 3(b), respectively. Hence, they have stated that 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.