Pharma dept sends reminder to all stakeholders
The proposal for price negotiation of patented drugs is being revisited by the government. While a new regime for price regulation of medicines, much more broader in coverage albeit lenient is in the offing, the department of pharmaceuticals recently sent a reminder to all stakeholders to send their comments on the pricing of patented medicines by Tuesday.
An earlier deadline of March 31 was extended because the comments received were not on “expected lines,” an official source said, without elaborating.
The move comes at a time India has made it clear through recent pronouncements by the political executive and the judiciary that making drugs affordable to the masses is a policy priority. New Delhi issued the first-ever compulsory licence (CL) only last year, to Natco Pharma to develop German drug major Bayer’s patented cancer treating medicine Sorafenib (brand name Nexawar). CL is a TRIPS-compliant provision in the Indian patent law that allows to sidestep patents and allow generic industry to produce patented drugs for concerns of public health. High prices of patented drugs can be a ground for invoking the CL provision. The Patent Controller’s order in favour of Natco was later also upheld by the Intellectual Property Appellate Board, giving the indication that India is pro public health.
The government is also contemplating grant of compulsory licences for three other cancer drugs, while Mumbai-based BDR Pharmaceuticals recently applied for a similar licence to make Bristol-Myers Squibb’s anti-cancer drug Sprycel.
Consent of the drug innovator is not necessary under this provision which allows a rare flexibility on patent protection included in the World Trade Organisation’s agreement on intellectual property.
They added that if a drug price is negotiated between a company and the government, prices could come down between 25% and 50%.
?Price negotiation would ensure that the affordability condition of the government is addressed in a better manner,? said Sujay Shetty, India leader (Pharma) at PricewaterhouseCoopers.
Patented medicines account for 1 % of India’s Rs 70,000 crore drug market, all made by multinational companies.
In Natco’s case, the CL was given on condition that its drug will not be sold for more than Rs 8,880 for a month’s dose as opposed to Rs 280,000 charged by the German drug maker.
Even BDR Pharma has promised to offer the product at a price that is over 95% cheaper for a month’s treatment. “As against Bristol-Myers Squibb’s monthly treatment cost of Rs 165,680, BDR will offer the product at Rs 8,100 per month, which works out to around 95.2 per cent cheaper,” BDR Pharma had said.