TIOL-DDT 2164 · Tuesday, 6 August 2013 · story 1 of 5

Exemption from getting ‘unregistered premises' registered for purpose of subjecting Scheduled formulations to re-printing, re-labeling, re-packing or stickering in pursuance of DPCO provisions

WHILE reporting Notification No. 22/2013-CX., Dated: July 29, 2013 in DDT 2160 dated July, 31, 2013, we had mentioned this -

"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."

Incidentally, the person whose unregistered premises is used for affixing a sticker or re-printing or re-labeling or re-packing of pharmaceutical products falling under Chapter 30 of the First Schedule to the CETA, 1985 with lower ceiling price to comply with the notifications issued by the National Pharmaceutical Pricing Authority under DPCO, 2013 and claiming the exemption under the notification could be held to be a "manufacturer" in terms of section 2(f)(iii) of the CEA, 1944 and if so he would be required to take a registration under section 6 of the CEA, 1944 read with rule 9 of the CER, 2002 and this again could complicate the entire exemption notification.

So, the Central Government has now come out with a notification granting exemption from registration under sub-rule (1) of rule 9 of the CER, 2002 to such persons who undertake the mandated activity in an ‘unregistered premises'.

But such manufacturers are already exempted from registration by Notification No. 36/2001-CENT dated 26.06.2001. Is there any need for another exemption? Board knows!

Notification No. ., Dated: August 2, 2013

Drugs (Prices Control) Order, 2013

cited in this story

  • TIOL-DDT 2160 · 31 July 2013 — “Scheduled formulations subjected to re-printing, re-labeling, re-packing or stickeringin pursuance of DPCO provisions granted CE exemption.”
  • 576/13/2001-CX — circular of 2001
  • 22/2013-CX — notification of 2013
  • 11/2013-CE (NT) — notification of 2013