Import of Excipients

[Adithya Srinivasan]

Can excipients be imported along with bulk drugs under SION for manufacture of Unregistered Drugs under Advance Authorisation Scheme ?

[KASTURI SETHI]

See Notification No.22/2025-Customs dated 1.4.15 as amended from time to time up to 30.3.20 read with Para No. 4.03, 4.05 and 4.18 of FTY 2015-20 revised. Catalyst is allowed.

[YAGAY and SUN]

Excipient and Catalyst are two different items/goods.

[Adithya Srinivasan]

I agree with Sri. YAGAY andSUN . We cannot categorise Excipients as catalyst. It is yet another independent RM.

[YAGAY and SUN]

Vide, CBEC Circular No. 28/2016-Customs dated 14-06-2016 the procedure related to drugs and cosmetics have been simplified. The Single Window Interface for Trade (SWIFT) provides the importers/exporters a single point interface for clearance of import and export goods thereby reducing dwell time and cost of doing business. Since its implementation, reports have been received highlighting problems faced by trade in relation to the import of drugs, cosmetics and medical equipment. The Board has examined these issues and in consultation with the Drug Controller General of India certain decisions have been taken to simplify the procedure for clearance of such goods:

Items that are Chemicals and Not drugs: Several items falling under different Customs Tariff Heads which have been mapped in SWIFT as requiring clearance from Assistant Drug Controller's (ADC) office 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 have been prepared and published on the ICEGATE website as part of PGA Exemption Category (PEC).The Board has already established a Working Group to examine all such items. 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).

Dual Use Items & Excipients: Several items falling under different Customs Tariff Heads which have been mapped in SWIFT as requiring clearance from Assistant Drug Controllers' (ADC) office have dual use (use for medicinal and non-medicinal purposes) and excipients (an inactive substance that can serve as the vehicle or medium for a drug or other active substance). A large number of importers are importing them for purposes other than drugs or medicinal use.

In respect of the category of dual-use items or excipients, in the Integrated Declaration, the items will normally not be referred to the ADC clearance.

[YAGAY and SUN]

for more information, please click on the following link.

http://www.jpec.gr.jp/newsletter/vol21no1/Schoneker-Excipient_Regulations_in_India.pdf

AI Summary

Import of Excipients treated as dual use items; typically not routed for drug controller clearance under SWIFT.
Excipients are distinct raw materials and not catalysts; proper Customs Tariff classification determines admissibility under import authorisation schemes. Under the single-window system and the PGA Exemption Category, chemicals that are not drugs and many dual-use items or excipients declared in the integrated import declaration will normally not be referred to drug controller offices for clearance, subject to the published exemption mapping and ongoing updates.