The Indian Drugs Manufacturers Association (IDMA) and Indian Pharmaceutical Alliance (IPA) have joined as co-petitioners in the Special Leave Petition (SLP) moved by SmithKline Beecham Pharmaceuticals (SKB) (Glaxo SmithKline India) appealing against the Karnataka High Court judgment favouring the DPCO provision relating to 15 days deadline to implement drug price revisions notified by the government. Admitting the petitions, the Supreme Court has instructed NPPA to submit a detailed affidavit within a month on the SLP jointly moved by the associations and the company.
The SC had already stayed all prosecution measures against the company by stating no prosecution measures should be initiated against Glaxo until the court takes a decision on the issue.
The Karnataka HC judgment to implement the price revision within 15 days from the date of notification has been a concern for the entire industry.
The court had upheld the contention of National Pharmaceutical Pricing Authority (NPPA) that the prices of scheduled formulations should be revised within 15 days of the notification regardless of the manufacturing date of the product.
The judgment, in relation to W.P. No.38973/98 filed by M/s. Smithkline Beecham Pharmaceuticals India Limited, Bangalore against Union of India and others, said that the provisions of the DPCO, 1995 are clear that prices should be revised with in 15 days even in regard to the formulations which were manufactured prior to the date of notification or those manufactured within 15 days from the date of notification.
The HC observed that " a combined reading of these provisions make it clear that every manufacturer and distributor is duty bound to issue a revised price list within 15 days from the date of the notification issued by the Government under Para 9 of DPCO. It is also clear that manufacturers, distributors and retailers will be liable to sell formulations from the date of such revised price list (which is required to be published within 15 days from the date of notification) at the revised prices and not the prices mentioned on the label of the container or pack. In view of this, the contention of the petitioner that revised prices will not apply to the existing stocks but only to new batches of drugs and formulations to be manufactured after 15 days of the notification cannot be accepted. The provisions of the DPCO are clear that prices should be revised within 15 days even in regard to the formulations which were manufactured prior to the date of notification or those manufactured within 15 days from the date of notification"..
Following the court order, the NPPA had directed the drug manufacturers to implement the prices in respect of bulk drugs / formulations fixed / notified by NPPA within 15 days of the notification and ensure that the stocks are sold after the stipulated period only at the prices fixed by the NPPA.
The industry associations feel that Glaxo lost the case in the HC only because it failed to present the matter in a clear way. The appeal is expected to give the industry a chance to put the industry views clearly before the court.