Commerce ministry has locked horns with the department of pharmaceuticals for the latter?s alleged inaction on the plan to bring patented drugs under a price negotiation system. There is no provision for any regulation on patented drugs in the proposed new pricing policy for drugs.
?The National Pharmaceutical Pricing Policy is restricted to generics alone and does not cover patented medicines. The department of pharmaceuticals had set up a committee on price negotiations of patented medicines and there has been no substantial outcome on the committee,? the commerce ministry said in a note to the group of ministers on pharma pricing policy. The ministry added that this (having no outcome from the committee) was a serious matter, adding that many of the life saving medicines, especially those for cancer, liver, hepatitis, were patented. It cited the recent grant of compulsory licence to Natco pharma for liver and kidney cancer to bring home the point that big price differential existed between patented and generic medicines.
This comes at a time when a few days back, a parliamentary standing committee on health has also asked the department of pharma to develop and implement a suitable mechanism to manage the price of imported drugs within next six months.
“The committee feels that the issue at hand is too urgent to be left open-ended and, therefore, recommends that department of pharma to resolve this issue within a period of six months. The committee would also like the department to put in place an effective mechanism to enable the use of international price benchmarks in such cases and limit the price of an imported drug by comparison with the price of the same drug in other countries and thus check windfall profits made by importers on selling imported molecules at exorbitant prices in the country,? the panel noted.
The panel noted non-existence of any method to regulate the prices of new patented drugs which are imported to the country and sold at ?supernormal profits?, whereas prices of the same medicines are considerably lower in other countries.
During a recent presentation to the GoM on pharma pricing, Jyoti Mirdha, member of Parliament, said ?Since 2003, over 1,277 ?registration certificates? have been issued to import finished formulations. Many of them, Mirdha said, are monopoly patented drugs and traders were importing and selling directly to patients on tips from doctors while prices of these medicines were neither being regulated nor monitored.
To buttress her point, Mirdha cited examples of drugs like breast cancer medicine Trastuzumab which costs over R1 lakh per dose and is prescribed for around one year.
She also furnished other instances such as cancer drugs like Retuximab which could cost R3 lakh per cycle, Sunitinib and Sorafenib (for which the first compulsory licence was granted in the country), which could cost well over R2 lakh per month to patient.