The new Drug Pricing. Battle Escalates !

Several pharma  companies  & Industry bodies like Indian Drug Manufacturers Association, Confederation of Indian Pharmaceutical Industry (CIPI)  already moved  to Court  and  few more expected join, to challenge the government's new drug pricing order that asked them to slash prices of 348 medicines and also  replace stocks in the market with those carrying reduced prices within 45 days of new price notification. 

The DCPO had ordered  earlier for reduction of prices of some medicines within 45 days of issuance of the  notification and that the decreased prices be made effective on drugs already in market.The deadline for  implementation of the notification ended on July 29.

Earlier  Indian Pharmaceutical Alliance,  estimated that with the application of the new price fixation methodology on a completely new set of medicines may see the Rs 100,000-crore industry losing about Rs 2,500 crore in revenues in the near term. Market intelligence firm AIOCD-AWACS estimates that the new price control system may hit the domestic revenues of majors Ranbaxy and Cipla by 6.2 and 5.8 per cent, respectively. 

 
Prices of 348 medicines, including life saving drugs are set to be cheaper by up to 80 per cent as the new Drug Price Control Order has come into effect.

As India pushes for compulsory drug licences,others looking for the new twists

The fight over drug patents in India is quickly spreading to  other areas  as other countries are looking at new twists on the model for getting their hands on cheaper drugs.

BDR Pharmaceuticals  has asked the Indian patent office to give it a compulsory license for a generic version of  BMS’s  cancer drug Sprycel (Dasatinib). Earlier Indian Supreme Court upheld the country’s first compulsory license granted last year to Natco Pharma to make a generic version of Bayer's kidney cancer drug Nexvar. It justified the decision to override the patent on prices. Natco began selling Nexavar for $170 a month, compared with Bayer's $5,000/month.

Others companies have also seen patents breached in recent months. Pfizer suffered the loss of IP protections on its cancer drug Sutent ( Challengers : Cipla & Natco ) and Roche's patent coverage on the hepatitis C treatment Pegasys been revoked.(Challengers : Sankalp Rehabilitation Trust)  Novartis  is still fighting for patent protection on its blood cancer treatment Gleevec (Challengers : Several Indian drug companies, Government of India)   and the Indian government has moved toward compulsory licenses on Roche's Herceptin.

Proponents of the aggressive attacks on patents say it is the only way for poor people in emerging countries to have a chance of getting the same lifesaving treatments that others in the world enjoy. It is an argument that has traveled well. 

China granted itself compulsory licensing rights last year but has yet to exercise them. Now a lobbying group is pushing Greece to adopt a compulsory license law, but not so Greek companies could make generics. The idea is that once the patents are neutralized, Greece could import cheap generics from other countries, like India.

Under India’s patent rules, compulsory licences can be issued when an inventor company fails to supply products at an affordable price. In such instances, other companies can go to court to get a licence to make the same products.

Reacting to  the such developments some U.S. Congress members said if India is going to continue to play loose with patent protections, maybe the U.S. needs to rethink an exemption for India on import duties that comes up for renewal in July.

Mylan to buy injectable drugs unit of Strides for $1.6 billion

Strides Arcolab Limited today announced that it has entered into a definitive agreement for the sale of its specialties subsidiary, Agila Specialties Private Limited, to US-based Mylan Inc  thus  ending  months of speculation regarding its sale, with reports suggesting Pfizer and Japan's Otsuka Holdings as other potential buyers.

Under the terms of the agreement, Strides and its subsidiary will receive an aggregate sum of $1.6 billion in cash on closing and a potential additional milestone payment of $ 250 M subject to the satisfaction of certain conditions by Strides.


This  deal will help Mylan, one of the world's largest generic drugmakers, to double its injectable drugs portfolio in combined  to more than 700 marketed injectables products and a global pipeline of more than 350 injectables products pending approval.

Media reports