Usha Sharma – Mumbai
Following the Department of Revenue’s notification to exempt scheduled formulations impacted by Drugs and Price Control Order 2013 (DPCO) from excise duty if they are re-printed, re-labelled, re-packed or re-stickered in premises other than those registered by the manufacturers, the Department of Pharmaceuticals (DoP) has decided to extend this exemption period by one month.
The extended exemption period starts on July 29 for the first batch of ceiling price notifications announced on June 14. Formulations under subsequent ceiling price notifications (dated June 12, June 28 and July 5) will also get a similar 30-day exemption from excise duty post the end of the 45-day period.
The DoP circular dated August 8 incorporates suggestions from a meeting held in Mumbai, which was attended by around 50 pharma companies and associations’ representatives in the presence of Dilsher Singh Kalha, Secretary, DoP; Chandra Prakash Singh, Chairman, NPPA and drug regulators from Gujarat and Maharashtra.
The pharma industry finds itself grappling with the logistics of implementing the revised prices as per DPCO 2013 within the set deadline. Cipla and Alembic were the first companies to challenge the order in the Delhi and Gujarat High Courts respectively, following which a few other pharma companies and two associations namely Indian Drugs Manufacturers Associations (IDMA) and Confederation of Indian Pharmaceutical Industry (CIPI) also approached the courts. After hearing all the filed petitions by the pharma companies and associations, the court has asked the DoP not to take coercive action against them.
This aggressive stance of the pharma industry has resulted in top officials from NPPA and DoP taking these measures to resolve the ongoing issues related to deadlines and price mechanism.
Discussing about the meeting’s outcome, Singh said, “During the meeting we have come across many queries which were raised by various pharma companies on different issues. However, we mainly focused on re-labelling and also issues related to the price fixation mechanism.”
Commenting on the steps taken by the pharma companies on challenging the price mechanism, Singh replied, “So far, we have come across two cases of challenging the price mechanism of and we have asked the respective companies to make individual presentations. If there are factual errors, we are ready to correct it, provided the companies give in writing about the factual errors.”
He also mentioned that the matter is still sub judice in Delhi High Court and the court has not given a stay order to the companies nor to the associations. However, the Delhi High Court has instructed the pharma companies and associations to submit copies of the manufacturers, stockists and dealers (agents/supplier) and present quantitative details about the price notifications before and after.
While signing off, Singh made it very clear that there will be no extension in the deadlines set for price revision.