Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 - CBEC's Customs Manual 2023 - Customs

9. Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945: 9.1 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 is 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. Further, the Drugs Controller General of India (DCGI) has clarified that 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, 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 labeled indicating that they are not for the - medicinal use or for some other purposes or are of commercial quality and are being labeled indicating that they are not for medicinal use. Accordingly, DCGI 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. 9.2 The points of entry specifically mentioned in Rule 43A are Chennai, Kolkata, Mumbai, Nhava Sheva, Cochin, Kandla, Delhi, Ahmedabad, Hyderabad and Ferozepur Cantonment, Amritsar, Ranaghat, Bongaon and Mohiassan Railways Stations. 9.3 As per rule 43A of the Drugs and Cosmetics Rules, 1945, drugs can be only imported into India through specified places. Accordingly, import of drugs at any other place may not be permitted. Further, whenever in doubt, field formations may seek necessary clarification about the generic name versus chemical name of medicines before clearance. The specified places are: (i) Ferozepore Cantonment and Amritsar Railway Stations (for drugs imported by rail across the frontier with Pakistan) (ii) Bongaon, Mohiassan and Ranaghat Railways Stations (for drugs imported by rail across the frontier with Bangladesh) (iii) Raxaul (for drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal) (iv) Chennai, Cochin, Kandla, Kolkata, Mumbai and Nhava Sheva (for drugs imported by sea) (v) Ahmedabad, Chennai, Delhi, Hyderabad, Kolkata and Mumbai (for drugs imported by airports) 9.4 Import consignments of Electronic Nicotine Delivery Systems (ENDS) including eCigarettes, Heat- Not- Burn devices, Vape, e-Sheesha, e- Nicotine Flavoured Hookah, and the like devices/ products may be referred to Assistant/ Deputy Drugs Controller for checking compliance. [Refer Circular No. 46/ 2018- Customs dated 27.11.2018 ] 9.5 The MoH FW vide Cigarettes and other Tobacco Products (Packaging and Labelling) Second Amendment Rules, 2018 notified by G.S.R. 331 (E) dated 03.04.2018 has specified a new set of health warnings w.e.f.01.09.2018. In addition to the existing statutory requirements, compliance of the amendments in health warning specifications prescribed by the COTP Amendment Rules, 2018 are to be ensured before clearance of import consignments or disposal of seized/confiscated tobacco products, including Cigarettes. [Refer Circular 20/2018-Customs dated 20.06.2018 , Circular No. 09/2017-Customs dated 29.03.2017 , Circular No. 27/2017-Customs dated 05.07.2017 Instructions vide F. No. 450/160/2009-Cus.IV dated 29.12.2009 ] 9.6 Single Window Project - Simplification of procedure in SWIFT for clearance of consignments related to drugs cosmetics: Several items falling under different Customs Tariff Heads which have been mapped are chemicals and not drugs. These are being routed for ADC's clearance by virtue of the Customs Tariff Heads under which they are declared, and the ADC's office routinely declares them as out of scope . In this regard, a list of such items has been prepared and published on the ICEGATE website as part of PGA Exemption Category (PEC).Importers of such goods should identify their items on this PEC list and include them as part of the Integrated Declaration in order to avoid unnecessary references to the ADC. The PEC will be duly updated after holding consultations in the Working Group and with the approval of the concerned PGAs (DCGI - in case of drugs and cosmetics items). [Refer circular 28/2016 dated 14.06.2016 ]