TIOL-DDT 2160 · Wednesday, 31 July 2013 · story 2 of 5

Scheduled formulations subjected to re-printing, re-labeling, re-packing or stickeringin pursuance of DPCO provisions granted CE exemption.

THE Central Government has granted conditional exemption to 'scheduled formulations' as defined under the DPCO, 2013 falling under Chapter 30 of the CETA, 1985 and which are subjected to re-printing, re-labeling, re-packing or stickering, in a premises which is not registered under the CEA, 1944 or the CER, in pursuance of the provisions contained in the said DPCO, from whole of the duty of excise leviable thereon subject to the following conditions, namely,

(i) The scheduled formulations, in respect of which the manufacturer is liable to ensure that the Maximum Retail Price (MRP) of such formulation does not exceed the ceiling price within forty-five days of the date of notification of the ceiling price by National Pharmaceuticals Pricing Authority (NPPA), have been removed from the place of removal on payment of appropriate duty ;

(ii) The re-printing, re-labeling, re-packing or stickering, of the scheduled formulations results in downward revision of the MRP;

(iii) In respect of a given scheduled formulation, the exemption shall be valid for a period of forty-five days from the date of publication of the notification of the ceiling price in respect of such scheduled formulation by NPPA or such extended period not exceeding thirty days as may be permitted by the Department of Pharmaceuticals;

(iv) The manufacturer shall submit a prior intimation to the jurisdictional Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise, as the case may be, containing a list of scheduled formulations requiring re-printing, re-labeling, re-packing or stickering alongwith the notification vide which these have been notified by NPPA, various locations and addresses thereof where the scheduled formulations are proposed to be re-printed, re-labelled, re-packed or stickered and the details such as description of the scheduled formulation, present MRP, proposed MRP, batch no., quantity and date of manufacture in respect of each such location. In the case of importer and marketer, they shall submit the intimation to the Assistant Commissioner of Central Excise or the Deputy Commissioner of Central Excise, as the case may be, having jurisdiction over their registered office;

(v) Subsequent to the aforesaid operations being carried out, the manufacturer shall submit the details in respect of the said scheduled formulations within a period of one month of such re-printing, re-labeling, re-packing or stickering.

Admittedly, scheduled formulations falling under Chapter Heading 3004 are notified in the Third Schedule to the Central Excise Act, 1944 and any process in relation to these goods involving packing or repacking of such goods in a unit container or labeling or re-labeling of containers including the declaration or alteration of retail sale price on it or adoption of any other treatment on the goods to render the product marketable to the consumer shall amount to manufacture u/s 2(f)(iii) of the CEA, 1944.

So, as not to impose any duty liability that arises because of the aforesaid process, of re-printing, re-labeling, re-packing or stickering, mandated by the DPCO but being construed as manufacture u/s 2(f) of the CEA, 1944, the Central government has in its wisdom issued the exemption notification. Nonetheless, what would be the duty liability if this activity is carried out by a formulation manufacturer in his registered manufacturing premises is a foregone conclusion. Also, if the ‘premises' carries a dealer registration whether he too would be out of this exemption remains unanswered. Another interesting fact is that the re-printing, re-labeling, re-packing or stickering, of the scheduled formulations should result in downward revision of the MRP else duty liability is attracted. A similar issue was discussed long back by the Board in Circular , dated May, 16, 2001.

Notification No. , Dated: July 29, 2013

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