Editorial + Font Resize -

PRICING PATENTED DRUGS

P A Francis | Wednesday, September 12, 2012, 08:00 Hrs [IST]

A fundamental flaw in the current drug pricing policy in India is the absence of regulation on high priced patented drugs. After the introduction of product patent regime in 2005, multinational drug companies have been importing large number of patented products for marketing in the domestic market. These drugs are being sold at exorbitant prices as the National Pharmaceutical Pricing Authority did not try to bring them under price control as yet. Most of the patented drugs are highly expensive on account of excessive profiteering, loading of huge trade commission and promotional costs. The need to have some kind of price control on patented drugs was felt soon after the new patent law was notified and when MNCs started introducing patented drugs in the Indian market. But the matter dragged on for years. An expert panel was set up by the Department of Pharmaceuticals for the purpose six years ago but no decision was arrived at so far. Even the draft proposal for new drug pricing policy brought out by the government last year leaves out the issue of pricing of patented drugs. Now, NPPA has approached the Department of Pharmaceuticals seeking an amendment of DPCO,1995 to bring pricing of all the imported drugs under its scrutiny and price control. How long this process will take is something to be watched.

Apart from excessive pricing of patented drugs, MNCs have been also claiming patent rights for products which are not actually new molecules since 2005. These companies have been filing applications for patenting different forms of the same drugs, like salt, polymorphs, analogues, crystalline and combinations with other drugs. By doing this, they just tried to corner a broader spectrum of protection for commercially significant forms of the same compound. The patent offices in the country have thus granted patents to dozens of products which do not merit patent protection at all. Filing of multiple patent applications for various forms of the same drug is possible within the framework of the amended Patent Act. A study conducted by Indian Pharmaceutical Alliance in 2009 found that at least 86 cases of patents granted for pharmaceutical products were just minor variations of existing molecules. And between 2005 and 2010, about 13,000 patents have been already issued to various chemicals and pharmaceuticals by Indian patent offices. Obtaining a patent implies an exclusive marketing right for the product for 20 years and if MNCs fix any price for such products without considering socio economic reality of the country that needs to be stopped in the public interest. Granting of patent right for a new drug product and charging a high price for it may be justifiable in case of a non essential drug but that cannot be allowed in case of a life saving drug in India.

Comments

Lessel

Sep 25, 2012 10:12 PM

Yeah as long as you have an invention down on paper and you have cfruaelly outlined what it does and how it works then all you have to do is send that off to a patent office you can find sites online which will give you the right numbers to call and the right people to email and where you have to mail your design. however be warned it can takes years for a patent to go through so get ya design sent off see if it can be patented and if it can do so. Plus if you have to wait a long time you may aswell get building a prototype it could also help speed up the patenting processhope this helps =] Was this answer helpful?

Ronak Patel

Sep 12, 2012 4:46 PM

It is not absolutely right that NPPA can not control the prices of patented products. as per DPCO, 1995, NPPA has an authority to control the prices of drugs which has turnover of more than 10 to 40 million INR and having single manufacturer with more than 90% market share. As well as price of regulated drug will not be high because MAPE ( Maximum Allowable Post-manufacturing Expenses) will be 100% for that drug. It means if manufacturing cost of drug was 1 INR then its price will be maximum 2 INR. But despite of this rule some drugs being regulated under NLEM-2003 are also showing price variation of 900 to 5000 pecentage. So it indicates that despite of being loophole in policy there is a more bigger loophole in implementation.